Advanced Malignancies
Conditions
Keywords
Solid tumors, Melanoma, Non small cell lung cancer, NSCLC, Renal cell carcinoma, RCC, Phase I-Ib/II, MBG453, PDR001, Checkpoint inhibitor, PD-1, TIM-3
Brief summary
The purpose of this first-in-human study of MBG453 was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. as a single agent or in combination with PDR001 or decitabine in adult patients with advanced solid tumors
Detailed description
This study was a first in human (FIH), open-label, Phase I-Ib/II, multi-center study which consisted of a Phase I dose escalation part of sabatolimab (MBG453) as single agent, and a Phase Ib dose escalation part of sabatolimab in combination with spartalizumab (PDR001) that commenced after two cohorts in the dose escalation with single agent were completed. Once the maximum tolerated dose (MTD)/recommended Phase II dose (RP2D) of sabatolimab as single agent and in combination with spartalizumab was achieved, a dose ranging part and a Phase II part started. • Phase I dose escalation part (sabatolimab single agent): In the Phase I part of the study, cohorts of subjects were treated with sabatolimab as single agent either every 2 weeks (Q2W) or every 4 weeks (Q4W) until the MTD was reached or a lower RP2D was established. The sabatolimab single agent dose escalation part in Japan ran separately in order to ensure that the safety and pharmacokinetics (PK) profiles of single-agent sabatolimab are adequately characterized in Japanese patients. If the recommended dose of single agent sabatolimab in Japanese patients was the same as in the rest of the world (ROW) patients, then patients enrolled in Japan were to be recruited into the other parts of the study. • Phase Ib dose escalation part (sabatolimab in combination with spartalizumab): The combination Phase Ib part of the study was to be commenced after at least two cohorts of sabatolimab as single agent were completed, and safety data suggested acceptable toxicity for subjects to begin treatment in combination. Following identification of the MTD/RP2D for the combination of sabatolimab and spartalizumab with a Q2W dosing schedule, a further dose escalation was planned to identify the MTD/RP2D with a Q4W dosing schedule. The sabatolimab in combination with decitabine treatment arm (Phase Ib) was not opened for enrollment. * Dose ranging part: During the dose ranging part various dose levels of single agent sabatolimab were tested to better understand the safety, tolerability and PK. * Phase II part (sabatolimab in combination with spartalizumab): Once the MTD and/or RP2D were declared for sabatolimab in combination with spartalizumab, additional subjects were enrolled in the Phase II part in the selected indications (melanoma and non-small cell lung carcinoma) in order to assess the preliminary anti-tumor activity. The Phase II single agent sabatolimab treatment arm was not opened for enrollment.
Interventions
DRUGMBG453
Anti human TIM-3 monoclonal antibody. MBG453 administered via intravenous (i.v.) infusion either every 2 weeks (Q2W) or every 4 weeks (Q4W).
DRUGPDR001
Anti-human PD-1 monoclonal antibody. PDR001 administered via intravenous (i.v.) infusion either every 2 weeks (Q2W) or every 4 weeks (Q4W).
DRUGDecitabine
commercially available chemotherapy
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically documented advanced or metastatic solid tumors. * Phase I-Ib part (including dose ranging part): Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST v1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists and who did not receive prior anti-PD-1/PD-L1 treatment. * Phase II part (MBG453 single agent): Patients with advanced/metastatic solid tumors in the indication in which at least one confirmed PR or CR was seen during the dose escalation phase I part. Patients must have measurable disease as determined by RECIST v1.1, have progressed despite standard therapy or be intolerant to standard therapy. * Phase II part (MBG453 in combination PDR001): Patients with advanced/metastatic tumors in the below selected indications, with at least one measurable lesion as determined by RECIST v1.1, who have received standard therapy and are intolerant of standard therapy or have progressed following their last prior therapy.: * Melanoma (anti-PD-1/PD-L1 therapy naïve or pre-treated) * Non small cell lung cancer (anti-PD-1/PD-L1 therapy naïve or pre-treated) * Renal Cell Carcinoma (anti-PD-1/PD-L1 therapy naïve or pre-treated) * Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening/baseline, and during therapy on the study. * For MBG453 in combination with decitabine: anti-PD-1/PD-L1 therapy naïve SCLC patients who have failed no more than two lines of standard chemotherapy including topotecan
Exclusion criteria
* Presence of symptomatic central nervous system metastases. * History of severe hypersensitivity reactions to other monoclonal antibodies. * Human Immunodeficiency Virus, Hepatitis B Virus or Hepatitis C Virus infection. * Active autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease or any condition that requires systemic steroids. * Systemic steroid therapy or any immunosuppressive therapy (≥10mg/day prednisone or equivalent). * Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment. * Pre-treatment with anti-CTLA4 antibodies in combination with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway. * Participation in an interventional, investigational non-immunotherapy study within 2 weeks of the first dose of study treatment. * Prior participation in an interventional, investigational cancer vaccine or immunotherapy study except for an anti-PD-1/PD-L1 study. * For MBG453 in combination with decitabine: Hypersensitivity to decitabine or to any of the excipients, listed in decitabine country specific label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | From first dose of study medication up to 30 days after last dose, with a maximum duration of 2 years for sabatolimab and 5 years for sabatolimab in combination with spartalizumab | Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration. |
| Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 28 days (sabatolimab single agent) and 56 days (sabatolimab+spartalizumab) | A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first cycle of treatment with sabatolimab as single agent or in the first two cycles of treatment when sabatolimab is given in combination with spartalizumab during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. The duration of one treatment cycle is 28 days. |
| Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | From first dose of study medication up to last dose, with a maximum duration of 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab | Number of participants with at least one dose reduction of sabatolimab and number of participants with at least one dose interruption of sabatolimab. |
| Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | From first dose of study medication up to last dose, with a maximum duration of 4.9 years | Number of participants with at least one dose reduction of spartalizumab and number of participants with at least one dose interruption of spartalizumab. |
| Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | From first dose of study medication up to last dose, with a maximum duration of 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab | Dose intensity of sabatolimab Q2W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 14 days. Dose intensity of sabatolimab Q4W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days. |
| Phase Ib: Dose Intensity of Spartalizumab | From first dose of study medication up to last dose, with a maximum duration of 4.9 years | Dose intensity of spartalizumab Q2W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 14 days. Dose intensity of spartalizumab Q4W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days. |
| Phase II: Overall Response Rate (ORR) Per RECIST v1.1 | From start of treatment until end of treatment, assessed up to 2.9 years | Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days. | PK parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. |
| Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days. | PK parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation. |
| Terminal Elimination Half-life (T1/2) of Sabatolimab | pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days. | PK parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. T1/2 was calculated by regression analysis of the terminal elimination phase. T1/2 was computed as 0.693/terminal elimination rate constant. |
| Maximum Observed Serum Concentration (Cmax) of Spartalizumab | pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days. | PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days. | PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. |
| Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days. | PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation. |
| Terminal Elimination Half-life (T1/2) of Spartalizumab | pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days. | PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. T1/2 was calculated by regression analysis of the terminal elimination phase. T1/2 was computed as 0.693/terminal elimination rate constant. |
| Number of Participants With Anti-sabatolimab Antibodies | Baseline (before first dose) and post-baseline (assessed throughout the treatment up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab) | Immunogenicity was evaluated in serum in a validated three-tiered assay approach. Samples were screened for potential anti-sabatolimab antibodies and positive screen results were confirmed using a confirmatory assay. For confirmed anti-drug antibodies (ADA) positive samples, titers were determined. Patient ADA status was defined as follows: * ADA-negative at baseline: ADA-negative sample at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples * ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative * Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample * Treatment-boosted ADA-positive = ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample |
| Number of Participants With Anti-spartalizumab Antibodies | Baseline (before first dose) and post-baseline (assessed throughout the treatment up to 4.9 years). | Immunogenicity was evaluated in serum in a validated three-tiered assay approach. Samples were screened for potential anti-spartalizumab antibodies and positive screen results were confirmed using a confirmatory assay. For confirmed anti-drug antibodies (ADA) positive samples, titers were determined. Patient ADA status was defined as follows: * ADA-negative at baseline: ADA-negative sample at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples * ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative * Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample * Treatment-boosted ADA-positive = ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample |
| Baseline Expression of PD-L1 | Screening | The tumor expression of programmed cell death-ligand 1 (PD-L1) was measured by immunohistochemical methods. This record summarizes the baseline expression of PD-1 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. |
| Best Overall Response (BOR) Per RECIST v1.1 | From start of treatment until end of treatment, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab | BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per RECIST v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression; NCRNPD: Persistence of one or more non-target lesions. Number of participants in each category is reported in the table. |
| Baseline Expression of TIM-3 | Screening | The tumor expression of T-cell Immunoglobulin domain and Mucin domain-3 (TIM-3) was measured by immunohistochemical methods. This record summarizes the baseline expression of TIM-3 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. |
| Baseline Expression of LAG-3 | Screening | The tumor expression of lymphocyte-activation gene-3 (LAG-3) was measured by immunohistochemical methods. This record summarizes the baseline expression of LAG-3 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. |
| Baseline Expression of CD163 | Screening | The tumor expression of CD163 was measured by immunohistochemical methods. This record summarizes the baseline expression of CD163 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. |
| Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | Baseline (screening) and post-baseline (assessed throughout the treatment up to maximum 193 days) | The count of TILs was performed by hematoxylin and eosin stain. |
| Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | From first dose of study medication up to 30 days after last dose, with a maximum duration of 3 years | Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration. |
| Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | From first dose of study medication up to last dose, with a maximum duration of 2.9 years | Number of participants with at least one dose reduction of sabatolimab and number of participants with at least one dose interruption of sabatolimab. |
| Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | From first dose of study medication up to last dose, with a maximum duration of 2.9 years | Number of participants with at least one dose reduction of spartalizumab and number of participants with at least one dose interruption of spartalizumab. |
| Phase II: Dose Intensity of Sabatolimab | From first dose of study medication up to last dose, with a maximum duration of 2.9 years | Dose intensity of sabatolimab was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days. |
| Phase II: Dose Intensity of Spartalizumab | From first dose of study medication up to last dose, with a maximum duration of 2.9 years | Dose intensity of spartalizumab was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days. |
| Baseline Expression of CD8+ | Screening | The tumor expression of CD8+ was measured by immunohistochemical methods. This record summarizes the baseline expression of CD8+ and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. |
| Progression-Free Survival (PFS) Per RECIST v1.1 | From start of treatment until first documented progression or death due to any cause, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab | PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1. PFS was analyzed using Kaplan-Meier estimates. |
| Duration of Response (DOR) Per RECIST v1.1 | From first documented response to first documented disease progression or death due to underlying cancer, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab | DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment according to RECIST v1.1. DOR is defined as the time from the date of first documented response to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, duration was censored at the date of last adequate tumor assessment. According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed CR or PR in each treatment group/arm. |
| Overall Response Rate (ORR) Per irRC | From start of treatment until end of treatment, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab | Tumor response was based on local investigator assessment as per irRC. ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of diameters. |
| Progression-Free Survival (PFS) Per irRC | From start of treatment until first documented and confirmed progression or death due to any cause, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab | PFS is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor evaluation. Tumor response was based on local investigator assessment per irRC. PFS was analyzed using Kaplan-Meier estimates. |
| Overall Survival (OS) | From start of treatment until death due to any cause, assessed up to 2 years for sabatolimab and 5.3 years for sabatolimab in combination with spartalizumab | OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. OS was estimated using Kaplan-Meier estimates. |
| Maximum Observed Serum Concentration (Cmax) of Sabatolimab | pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days. | Pharmacokinetic (PK) parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
Countries
Canada, Italy, Japan, Netherlands, Singapore, South Korea, Switzerland, Taiwan, United States
Participant flow
Recruitment details
Participants took part in 14 investigative sites in 9 countries.
Pre-assignment details
The screening period began once patients had signed the study informed consent. Screening evaluations were performed within 28 days prior to the first dose of study medication. After screening, the treatment period started on Cycle 1 Day 1.
Participants by arm
| Arm | Count |
|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW Sabatolimab 80 mg every 2 weeks (Q2W) in Phase I Dose Escalation Part in rest of the world (ROW) patients | 14 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW Sabatolimab 240 mg Q2W in Phase I Dose Escalation Part in ROW patients | 9 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW Sabatolimab 800 mg Q2W in Phase I Dose Escalation Part in ROW patients | 16 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW Sabatolimab 1200 mg Q2W in Phase I Dose Escalation Part in ROW patients | 5 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan Sabatolimab 80 mg Q2W in Phase I Dose Escalation Part in Japanese patients | 2 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan Sabatolimab 240 mg Q2W in Phase I Dose Escalation Part in Japanese patients | 4 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan Sabatolimab 800 mg Q2W in Phase I Dose Escalation Part in Japanese patients | 6 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan Sabatolimab 1200 mg Q2W in Phase I Dose Escalation Part in Japanese participants | 2 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW Sabatolimab 240 mg every 4 weeks (Q4W) in Phase I Dose Escalation Part in ROW patients | 8 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW Sabatolimab 800 mg Q4W in Phase I Dose Escalation Part in ROW patients | 9 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW Sabatolimab 1200 mg Q4W in Phase I Dose Escalation Part in ROW patients | 6 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan Sabatolimab 1200 mg Q4W in Phase I Dose Escalation Part in Japanese patients | 6 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Sabatolimab 20 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part | 6 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Sabatolimab 80 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part | 13 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Sabatolimab 240 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part | 6 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Sabatolimab 240 mg Q2W in combination with spartalizumab 240 mg Q2W in Phase Ib Dose Escalation Part | 5 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Sabatolimab 800 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part | 5 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Sabatolimab 800 mg Q2W in combination with spartalizumab 240 mg Q2W in Phase Ib Dose Escalation Part | 6 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Sabatolimab 80 mg Q4W in combination with spartalizumab 80 mg Q4W in Phase Ib Dose Escalation Part | 6 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Sabatolimab 80 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part | 3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Sabatolimab 240 mg Q4W in combination with spartalizumab 80 mg Q4W in Phase Ib Dose Escalation Part | 12 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Sabatolimab 240 mg Q4W in combination with spartalizumab 240 mg Q4W in Phase Ib Dose Escalation Part | 5 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Sabatolimab 240 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part | 7 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part | 6 |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Sabatolimab 1200 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part | 6 |
| Dose Ranging Part: MBG453 80mg Q4W Sabatolimab 80 mg Q4W in Dose Ranging Part | 14 |
| Dose Ranging Part: MBG453 240mg Q4W Sabatolimab 240 mg Q4W in Dose Ranging Part | 17 |
| Dose Ranging Part: MBG453 1200mg Q4W Sabatolimab 1200 mg Q4W in Dose Ranging Part | 15 |
| Phase II: MBG453 + PDR001 NSCLC Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in non-small cell lung carcinoma (NSCLC) | 17 |
| Phase II: MBG453 + PDR001 Melanoma Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in melanoma | 16 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 4 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 2 | 1 | 1 |
| Overall Study | Progressive disease | 12 | 8 | 13 | 5 | 2 | 4 | 6 | 2 | 5 | 6 | 5 | 5 | 4 | 11 | 6 | 3 | 5 | 5 | 5 | 2 | 10 | 4 | 5 | 5 | 3 | 11 | 16 | 11 | 10 | 15 |
| Overall Study | Subject/guardian decision | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Dose Ranging Part: MBG453 80mg Q4W | Dose Ranging Part: MBG453 240mg Q4W | Dose Ranging Part: MBG453 1200mg Q4W | Phase II: MBG453 + PDR001 NSCLC | Phase II: MBG453 + PDR001 Melanoma | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 13.8 | 50.7 years STANDARD_DEVIATION 16.69 | 53.6 years STANDARD_DEVIATION 15.95 | 57.2 years STANDARD_DEVIATION 8.07 | 73.0 years STANDARD_DEVIATION 8.49 | 65.8 years STANDARD_DEVIATION 5.74 | 54.0 years STANDARD_DEVIATION 16.64 | 55.0 years STANDARD_DEVIATION 7.07 | 56.1 years STANDARD_DEVIATION 12.76 | 62.2 years STANDARD_DEVIATION 10.86 | 60.8 years STANDARD_DEVIATION 13.09 | 63.5 years STANDARD_DEVIATION 7.4 | 47.8 years STANDARD_DEVIATION 13.92 | 56.9 years STANDARD_DEVIATION 13.98 | 56.5 years STANDARD_DEVIATION 16.56 | 54.6 years STANDARD_DEVIATION 15.87 | 56.0 years STANDARD_DEVIATION 10.58 | 54.0 years STANDARD_DEVIATION 12.77 | 54.2 years STANDARD_DEVIATION 14.47 | 62.3 years STANDARD_DEVIATION 22.37 | 66.0 years STANDARD_DEVIATION 7.02 | 59.4 years STANDARD_DEVIATION 20.16 | 61.3 years STANDARD_DEVIATION 14.51 | 53.8 years STANDARD_DEVIATION 10.36 | 57.7 years STANDARD_DEVIATION 12.16 | 57.4 years STANDARD_DEVIATION 12.2 | 59.4 years STANDARD_DEVIATION 10.12 | 57.3 years STANDARD_DEVIATION 11.85 | 64.5 years STANDARD_DEVIATION 10.28 | 61.8 years STANDARD_DEVIATION 11.35 | 58.4 years STANDARD_DEVIATION 12.8 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 4 Participants | 6 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 6 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants | 8 Participants | 66 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 12 Participants | 9 Participants | 12 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 9 Participants | 5 Participants | 0 Participants | 2 Participants | 11 Participants | 4 Participants | 4 Participants | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 10 Participants | 4 Participants | 5 Participants | 3 Participants | 5 Participants | 12 Participants | 15 Participants | 14 Participants | 11 Participants | 8 Participants | 177 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 5 Participants | 3 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 6 Participants | 4 Participants | 3 Participants | 3 Participants | 2 Participants | 7 Participants | 2 Participants | 2 Participants | 0 Participants | 4 Participants | 3 Participants | 2 Participants | 5 Participants | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 10 Participants | 14 Participants | 13 Participants | 3 Participants | 8 Participants | 132 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 11 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 6 Participants | 4 Participants | 3 Participants | 5 Participants | 2 Participants | 3 Participants | 1 Participants | 7 Participants | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 2 Participants | 14 Participants | 8 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk | EG032 affected / at risk | EG033 affected / at risk | EG034 affected / at risk | EG035 affected / at risk | EG036 affected / at risk | EG037 affected / at risk | EG038 affected / at risk | EG039 affected / at risk | EG040 affected / at risk | EG041 affected / at risk | EG042 affected / at risk | EG043 affected / at risk | EG044 affected / at risk | EG045 affected / at risk | EG046 affected / at risk | EG047 affected / at risk | EG048 affected / at risk | EG049 affected / at risk | EG050 affected / at risk | EG051 affected / at risk | EG052 affected / at risk | EG053 affected / at risk | EG054 affected / at risk | EG055 affected / at risk | EG056 affected / at risk | EG057 affected / at risk | EG058 affected / at risk | EG059 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 14 | 4 / 9 | 6 / 16 | 5 / 5 | 1 / 2 | 4 / 4 | 5 / 6 | 1 / 2 | 3 / 8 | 4 / 9 | 4 / 6 | 3 / 6 | 1 / 6 | 5 / 13 | 2 / 6 | 5 / 5 | 2 / 5 | 3 / 6 | 0 / 6 | 3 / 3 | 5 / 12 | 2 / 5 | 1 / 7 | 2 / 6 | 4 / 6 | 8 / 14 | 9 / 17 | 6 / 15 | 9 / 17 | 6 / 16 | 3 / 5 | 4 / 5 | 7 / 10 | 0 / 0 | 1 / 1 | 0 / 0 | 1 / 1 | 1 / 1 | 3 / 5 | 3 / 5 | 1 / 2 | 3 / 3 | 2 / 5 | 4 / 8 | 3 / 4 | 0 / 0 | 2 / 3 | 2 / 3 | 2 / 6 | 0 / 0 | 6 / 7 | 2 / 3 | 3 / 6 | 2 / 4 | 1 / 2 | 4 / 6 | 3 / 8 | 7 / 9 | 8 / 8 | 7 / 10 |
| other Total, other adverse events | 13 / 14 | 9 / 9 | 14 / 16 | 5 / 5 | 2 / 2 | 4 / 4 | 6 / 6 | 2 / 2 | 7 / 8 | 9 / 9 | 5 / 6 | 6 / 6 | 6 / 6 | 12 / 13 | 6 / 6 | 5 / 5 | 5 / 5 | 6 / 6 | 6 / 6 | 3 / 3 | 11 / 12 | 5 / 5 | 6 / 7 | 6 / 6 | 6 / 6 | 13 / 14 | 17 / 17 | 14 / 15 | 17 / 17 | 15 / 16 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 6 / 14 | 1 / 9 | 9 / 16 | 2 / 5 | 0 / 2 | 0 / 4 | 0 / 6 | 0 / 2 | 3 / 8 | 6 / 9 | 4 / 6 | 0 / 6 | 2 / 6 | 7 / 13 | 2 / 6 | 5 / 5 | 4 / 5 | 0 / 6 | 4 / 6 | 1 / 3 | 2 / 12 | 3 / 5 | 2 / 7 | 4 / 6 | 5 / 6 | 10 / 14 | 8 / 17 | 9 / 15 | 9 / 17 | 5 / 16 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Phase Ib: Dose Intensity of Spartalizumab
Dose intensity of spartalizumab Q2W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 14 days. Dose intensity of spartalizumab Q4W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 4.9 years
Population: All patients in Phase Ib who received at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase Ib: Dose Intensity of Spartalizumab | 77.36 milligrams | Standard Deviation 4.171 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase Ib: Dose Intensity of Spartalizumab | 77.83 milligrams | Standard Deviation 3.957 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase Ib: Dose Intensity of Spartalizumab | 78.73 milligrams | Standard Deviation 5.017 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase Ib: Dose Intensity of Spartalizumab | 230.24 milligrams | Standard Deviation 19.982 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase Ib: Dose Intensity of Spartalizumab | 74.39 milligrams | Standard Deviation 7.953 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase Ib: Dose Intensity of Spartalizumab | 229.12 milligrams | Standard Deviation 26.871 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase Ib: Dose Intensity of Spartalizumab | 76.39 milligrams | Standard Deviation 5.315 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase Ib: Dose Intensity of Spartalizumab | 400.53 milligrams | Standard Deviation 0.92 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase Ib: Dose Intensity of Spartalizumab | 79.79 milligrams | Standard Deviation 1.409 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase Ib: Dose Intensity of Spartalizumab | 236.00 milligrams | Standard Deviation 7.8 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase Ib: Dose Intensity of Spartalizumab | 383.22 milligrams | Standard Deviation 36.754 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase Ib: Dose Intensity of Spartalizumab | 377.89 milligrams | Standard Deviation 51.948 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase Ib: Dose Intensity of Spartalizumab | 398.72 milligrams | Standard Deviation 3.14 |
Primary
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab
Number of participants with at least one dose reduction of spartalizumab and number of participants with at least one dose interruption of spartalizumab.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 4.9 years
Population: All patients in Phase Ib who received at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 2 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 2 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 2 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 2 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
Primary
Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab
Dose intensity of sabatolimab Q2W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 14 days. Dose intensity of sabatolimab Q4W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
Population: All patients in Phase I-Ib and Dose ranging Part who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 78.35 milligrams | Standard Deviation 4.678 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 235.60 milligrams | Standard Deviation 17.14 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 728.06 milligrams | Standard Deviation 164.525 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 1203.03 milligrams | Standard Deviation 15.891 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 80.00 milligrams | Standard Deviation 0 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 217.50 milligrams | Standard Deviation 28.723 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 758.03 milligrams | Standard Deviation 57.03 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 1208.70 milligrams | Standard Deviation 12.298 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 240.19 milligrams | Standard Deviation 1.954 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 752.29 milligrams | Standard Deviation 123.021 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 1193.10 milligrams | Standard Deviation 16.893 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 1196.49 milligrams | Standard Deviation 8.595 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 19.34 milligrams | Standard Deviation 1.043 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 78.58 milligrams | Standard Deviation 2.872 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 236.19 milligrams | Standard Deviation 15.05 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 230.24 milligrams | Standard Deviation 19.982 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 743.88 milligrams | Standard Deviation 79.534 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 763.72 milligrams | Standard Deviation 89.571 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 76.39 milligrams | Standard Deviation 5.315 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 80.11 milligrams | Standard Deviation 0.184 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 239.36 milligrams | Standard Deviation 4.227 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 236.00 milligrams | Standard Deviation 7.8 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 230.28 milligrams | Standard Deviation 21.179 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 755.79 milligrams | Standard Deviation 103.897 |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 1196.15 milligrams | Standard Deviation 9.421 |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 79.55 milligrams | Standard Deviation 1.661 |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 239.68 milligrams | Standard Deviation 4.977 |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab | 1192.33 milligrams | Standard Deviation 23.366 |
Primary
Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
Time frame: From first dose of study medication up to 30 days after last dose, with a maximum duration of 2 years for sabatolimab and 5 years for sabatolimab in combination with spartalizumab
Population: All patients in Phase I-Ib and Dose ranging Part who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 4 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 9 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 13 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 13 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 2 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 3 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 5 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 3 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 4 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 9 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 3 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 14 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 1 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 6 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 12 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 6 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 6 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 2 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 1 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 4 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 2 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 2 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 2 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 3 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 3 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 6 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 2 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 1 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 2 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 2 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 3 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 7 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 7 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 9 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 2 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 7 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 6 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 7 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 1 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 5 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 2 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 3 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 4 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 4 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 3 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 3 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 1 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 2 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 2 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 5 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 4 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 2 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 3 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 6 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 12 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 7 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 9 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 3 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 12 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 2 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 4 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 4 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 5 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 5 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 4 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 3 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 2 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 3 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 4 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 4 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 6 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 4 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 4 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 3 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 3 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 2 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 10 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 11 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 2 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 5 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 6 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 7 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 1 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 1 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 5 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 2 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 6 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 2 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 1 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 2 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 5 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 4 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 3 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 1 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 13 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 1 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 1 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 12 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 10 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 8 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 0 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 7 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 1 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 1 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 7 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 7 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 17 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 17 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 7 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 12 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 2 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 14 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 10 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 0 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 2 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 10 Participants |
Primary
Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab
Number of participants with at least one dose reduction of sabatolimab and number of participants with at least one dose interruption of sabatolimab.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
Population: All patients in Phase I-Ib and Dose ranging Part who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 2 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 2 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 3 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 2 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 1 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 2 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 2 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 2 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 2 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 1 Participants |
Primary
Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs)
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first cycle of treatment with sabatolimab as single agent or in the first two cycles of treatment when sabatolimab is given in combination with spartalizumab during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. The duration of one treatment cycle is 28 days.
Time frame: 28 days (sabatolimab single agent) and 56 days (sabatolimab+spartalizumab)
Population: Patients in Phase I-Ib who either met the minimum exposure criterion defined in the protocol and had sufficient safety evaluations, or had experienced a DLT during Cycle 1 or Cycle 2 (combination arm only)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
Primary
Phase II: Overall Response Rate (ORR) Per RECIST v1.1
Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: From start of treatment until end of treatment, assessed up to 2.9 years
Population: All patients in Phase II who received at least one full or partial dose of the combination sabatolimab+spartalizumab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Overall Response Rate (ORR) Per RECIST v1.1 | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Overall Response Rate (ORR) Per RECIST v1.1 | 0 Percentage of participants |
Secondary
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab
PK parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
Time frame: pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure in each timepoint. PAS consists of all patients who have at least one blood sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 128 day*µg/mL | Standard Deviation 33.2 |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 172 day*µg/mL | Standard Deviation 157 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 1350 day*µg/mL | Standard Deviation 576 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 555 day*µg/mL | Standard Deviation 191 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 3270 day*µg/mL | Standard Deviation 900 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 1670 day*µg/mL | Standard Deviation 438 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 4980 day*µg/mL | — |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 2780 day*µg/mL | Standard Deviation 862 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 231 day*µg/mL | Standard Deviation 4.77 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 463 day*µg/mL | Standard Deviation 47.9 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 2300 day*µg/mL | Standard Deviation 407 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 2070 day*µg/mL | Standard Deviation 570 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 3220 day*µg/mL | Standard Deviation 107 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 851 day*µg/mL | Standard Deviation 425 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 1100 day*µg/mL | Standard Deviation 559 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 2290 day*µg/mL | Standard Deviation 793 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 3590 day*µg/mL | Standard Deviation 1120 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 2800 day*µg/mL | — |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 2800 day*µg/mL | Standard Deviation 921 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 9080 day*µg/mL | Standard Deviation 648 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 4480 day*µg/mL | Standard Deviation 1610 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 86.5 day*µg/mL | — |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 321 day*µg/mL | — |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 357 day*µg/mL | Standard Deviation 356 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 126 day*µg/mL | Standard Deviation 34.7 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 502 day*µg/mL | Standard Deviation 146 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 824 day*µg/mL | Standard Deviation 149 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 393 day*µg/mL | Standard Deviation 197 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 3110 day*µg/mL | Standard Deviation 721 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 1550 day*µg/mL | Standard Deviation 115 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 1450 day*µg/mL | Standard Deviation 546 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 4040 day*µg/mL | Standard Deviation 894 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 165 day*µg/mL | Standard Deviation 57.3 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 149 day*µg/mL | Standard Deviation 63.1 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 109 day*µg/mL | Standard Deviation 57.5 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 124 day*µg/mL | — |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 710 day*µg/mL | Standard Deviation 337 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 673 day*µg/mL | Standard Deviation 245 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 606 day*µg/mL | Standard Deviation 302 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 1310 day*µg/mL | Standard Deviation 603 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 702 day*µg/mL | Standard Deviation 329 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 989 day*µg/mL | Standard Deviation 425 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 2690 day*µg/mL | Standard Deviation 1060 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 1870 day*µg/mL | Standard Deviation 570 |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 3530 day*µg/mL | — |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 3450 day*µg/mL | Standard Deviation 2020 |
| Dose Ranging Part: MBG453 80mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 223 day*µg/mL | Standard Deviation 75.5 |
| Dose Ranging Part: MBG453 80mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 216 day*µg/mL | Standard Deviation 85.3 |
| Dose Ranging Part: MBG453 240mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 805 day*µg/mL | Standard Deviation 278 |
| Dose Ranging Part: MBG453 240mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 892 day*µg/mL | Standard Deviation 499 |
| Dose Ranging Part: MBG453 1200mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 3730 day*µg/mL | Standard Deviation 1640 |
| Dose Ranging Part: MBG453 1200mg Q4W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 3710 day*µg/mL | Standard Deviation 1280 |
| Phase II: MBG453 + PDR001 NSCLC | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 1820 day*µg/mL | Standard Deviation 735 |
| Phase II: MBG453 + PDR001 NSCLC | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 3060 day*µg/mL | Standard Deviation 1230 |
| Phase II: MBG453 + PDR001 Melanoma | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 1 | 2430 day*µg/mL | Standard Deviation 988 |
| Phase II: MBG453 + PDR001 Melanoma | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sabatolimab | Cycle 3 | 4390 day*µg/mL | Standard Deviation 1610 |
Secondary
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab
PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
Time frame: pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure in each timepoint. PAS consists of all patients who have at least one blood sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 197 day*µg/mL | Standard Deviation 61.5 |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 366 day*µg/mL | Standard Deviation 147 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 389 day*µg/mL | Standard Deviation 123 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 166 day*µg/mL | Standard Deviation 44.3 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 160 day*µg/mL | Standard Deviation 45.5 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 314 day*µg/mL | Standard Deviation 43 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 470 day*µg/mL | Standard Deviation 173 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 348 day*µg/mL | Standard Deviation 74.2 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 152 day*µg/mL | Standard Deviation 45.3 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 1280 day*µg/mL | Standard Deviation 213 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 502 day*µg/mL | Standard Deviation 157 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 355 day*µg/mL | Standard Deviation 58.4 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 279 day*µg/mL | Standard Deviation 89.5 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 888 day*µg/mL | Standard Deviation 452 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 1800 day*µg/mL | — |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 291 day*µg/mL | Standard Deviation 313 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 266 day*µg/mL | Standard Deviation 154 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 773 day*µg/mL | Standard Deviation 289 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 1540 day*µg/mL | Standard Deviation 558 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 2080 day*µg/mL | Standard Deviation 837 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 1300 day*µg/mL | Standard Deviation 735 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 1120 day*µg/mL | Standard Deviation 366 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 1680 day*µg/mL | Standard Deviation 610 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 1620 day*µg/mL | — |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 1180 day*µg/mL | Standard Deviation 501 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 1870 day*µg/mL | Standard Deviation 775 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 1070 day*µg/mL | Standard Deviation 322 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 1 | 1570 day*µg/mL | Standard Deviation 747 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab | Cycle 3 | 2890 day*µg/mL | Standard Deviation 741 |
Secondary
Baseline Expression of CD163
The tumor expression of CD163 was measured by immunohistochemical methods. This record summarizes the baseline expression of CD163 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1.
Time frame: Screening
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab and had a valid assessment for the outcome measure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of CD163 | Clinical benefit | 3.12 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of CD163 | No clinical benefit | 11.53 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of CD163 | Clinical benefit | 0.26 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of CD163 | No clinical benefit | 9.48 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of CD163 | Clinical benefit | 6.05 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of CD163 | No clinical benefit | 5.22 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Baseline Expression of CD163 | No clinical benefit | 3.92 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Baseline Expression of CD163 | No clinical benefit | 7.60 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of CD163 | Clinical benefit | 14.56 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of CD163 | No clinical benefit | 0.98 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of CD163 | No clinical benefit | 14.30 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of CD163 | Clinical benefit | 15.47 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Baseline Expression of CD163 | No clinical benefit | 3.66 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Baseline Expression of CD163 | No clinical benefit | 6.95 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Baseline Expression of CD163 | Clinical benefit | 0.42 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Baseline Expression of CD163 | No clinical benefit | 7.36 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Baseline Expression of CD163 | Clinical benefit | 3.79 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Baseline Expression of CD163 | No clinical benefit | 19.69 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of CD163 | No clinical benefit | 5.78 percent marker area expression of CD163 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of CD163 | Clinical benefit | 5.53 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD163 | Clinical benefit | 6.76 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD163 | No clinical benefit | 16.17 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD163 | No clinical benefit | 26.28 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD163 | Clinical benefit | 21.36 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD163 | Clinical benefit | 0.41 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD163 | No clinical benefit | 6.23 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Baseline Expression of CD163 | No clinical benefit | 10.36 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD163 | No clinical benefit | 5.08 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD163 | Clinical benefit | 12.93 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of CD163 | Clinical benefit | 1.66 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of CD163 | No clinical benefit | 11.11 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of CD163 | Clinical benefit | 3.44 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of CD163 | No clinical benefit | 1.14 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD163 | No clinical benefit | 28.64 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of CD163 | Clinical benefit | 7.09 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of CD163 | No clinical benefit | 10.62 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Baseline Expression of CD163 | Clinical benefit | 26.40 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Baseline Expression of CD163 | No clinical benefit | 3.67 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD163 | Clinical benefit | 12.40 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD163 | No clinical benefit | 1.41 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD163 | No clinical benefit | 3.47 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD163 | Clinical benefit | 5.46 percent marker area expression of CD163 |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD163 | No clinical benefit | 5.80 percent marker area expression of CD163 |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of CD163 | No clinical benefit | 5.78 percent marker area expression of CD163 |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of CD163 | Clinical benefit | 5.66 percent marker area expression of CD163 |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of CD163 | Clinical benefit | 7.41 percent marker area expression of CD163 |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of CD163 | No clinical benefit | 4.92 percent marker area expression of CD163 |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of CD163 | No clinical benefit | 3.56 percent marker area expression of CD163 |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of CD163 | Clinical benefit | 5.41 percent marker area expression of CD163 |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of CD163 | Clinical benefit | 16.34 percent marker area expression of CD163 |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of CD163 | No clinical benefit | 17.46 percent marker area expression of CD163 |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of CD163 | Clinical benefit | 36.59 percent marker area expression of CD163 |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of CD163 | No clinical benefit | 11.88 percent marker area expression of CD163 |
Secondary
Baseline Expression of CD8+
The tumor expression of CD8+ was measured by immunohistochemical methods. This record summarizes the baseline expression of CD8+ and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1.
Time frame: Screening
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab and had a valid assessment for the outcome measure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of CD8+ | No clinical benefit | 2.17 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of CD8+ | Clinical benefit | 0.35 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of CD8+ | No clinical benefit | 0.90 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of CD8+ | Clinical benefit | 0.35 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of CD8+ | No clinical benefit | 0.13 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of CD8+ | Clinical benefit | 0.73 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Baseline Expression of CD8+ | No clinical benefit | 0.65 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Baseline Expression of CD8+ | No clinical benefit | 4.28 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of CD8+ | No clinical benefit | 0.21 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of CD8+ | Clinical benefit | 1.00 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of CD8+ | No clinical benefit | 0.37 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of CD8+ | Clinical benefit | 5.54 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Baseline Expression of CD8+ | No clinical benefit | 0.68 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Baseline Expression of CD8+ | No clinical benefit | 0.29 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Baseline Expression of CD8+ | Clinical benefit | 0.04 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Baseline Expression of CD8+ | Clinical benefit | 0.01 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Baseline Expression of CD8+ | No clinical benefit | 0.22 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Baseline Expression of CD8+ | No clinical benefit | 0.55 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of CD8+ | No clinical benefit | 0.11 percent marker area expression of CD8+ |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of CD8+ | Clinical benefit | 0.26 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD8+ | Clinical benefit | 0.47 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD8+ | No clinical benefit | 4.76 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD8+ | Clinical benefit | 2.07 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD8+ | No clinical benefit | 4.58 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD8+ | No clinical benefit | 1.25 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD8+ | Clinical benefit | 0.09 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Baseline Expression of CD8+ | No clinical benefit | 0.42 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD8+ | No clinical benefit | 0.16 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Baseline Expression of CD8+ | Clinical benefit | 8.32 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of CD8+ | Clinical benefit | 0.03 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of CD8+ | No clinical benefit | 3.56 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of CD8+ | Clinical benefit | 0.08 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of CD8+ | No clinical benefit | 0.10 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD8+ | No clinical benefit | 0.96 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of CD8+ | Clinical benefit | 0.60 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of CD8+ | No clinical benefit | 0.59 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Baseline Expression of CD8+ | Clinical benefit | 3.81 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD8+ | Clinical benefit | 3.87 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD8+ | No clinical benefit | 0.18 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD8+ | Clinical benefit | 0.55 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD8+ | No clinical benefit | 0.12 percent marker area expression of CD8+ |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Baseline Expression of CD8+ | No clinical benefit | 0.11 percent marker area expression of CD8+ |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of CD8+ | No clinical benefit | 0.16 percent marker area expression of CD8+ |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of CD8+ | Clinical benefit | 0.90 percent marker area expression of CD8+ |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of CD8+ | Clinical benefit | 0.60 percent marker area expression of CD8+ |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of CD8+ | No clinical benefit | 0.71 percent marker area expression of CD8+ |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of CD8+ | No clinical benefit | 0.38 percent marker area expression of CD8+ |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of CD8+ | Clinical benefit | 0.11 percent marker area expression of CD8+ |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of CD8+ | Clinical benefit | 7.08 percent marker area expression of CD8+ |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of CD8+ | No clinical benefit | 3.36 percent marker area expression of CD8+ |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of CD8+ | No clinical benefit | 3.47 percent marker area expression of CD8+ |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of CD8+ | Clinical benefit | 6.67 percent marker area expression of CD8+ |
Secondary
Baseline Expression of LAG-3
The tumor expression of lymphocyte-activation gene-3 (LAG-3) was measured by immunohistochemical methods. This record summarizes the baseline expression of LAG-3 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1.
Time frame: Screening
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab and had a valid assessment for the outcome measure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of LAG-3 | Clinical benefit | 0.24 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of LAG-3 | No clinical benefit | 1.61 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of LAG-3 | No clinical benefit | 0.69 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of LAG-3 | Clinical benefit | 0.08 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of LAG-3 | No clinical benefit | 2.68 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of LAG-3 | Clinical benefit | 0.23 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Baseline Expression of LAG-3 | No clinical benefit | 0.11 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Baseline Expression of LAG-3 | No clinical benefit | 2.11 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of LAG-3 | Clinical benefit | 1.30 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of LAG-3 | No clinical benefit | 0.02 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of LAG-3 | Clinical benefit | 7.12 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of LAG-3 | No clinical benefit | 0.14 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Baseline Expression of LAG-3 | No clinical benefit | 0.58 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Baseline Expression of LAG-3 | Clinical benefit | 0.03 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Baseline Expression of LAG-3 | No clinical benefit | 0.10 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Baseline Expression of LAG-3 | No clinical benefit | 0.05 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Baseline Expression of LAG-3 | No clinical benefit | 0.18 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of LAG-3 | No clinical benefit | 0.06 percent marker area expression of LAG-3 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of LAG-3 | Clinical benefit | 0.02 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of LAG-3 | Clinical benefit | 0.31 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of LAG-3 | No clinical benefit | 7.63 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of LAG-3 | No clinical benefit | 1.49 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of LAG-3 | Clinical benefit | 2.44 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of LAG-3 | Clinical benefit | 0.00 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of LAG-3 | No clinical benefit | 0.78 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Baseline Expression of LAG-3 | No clinical benefit | 0.30 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Baseline Expression of LAG-3 | No clinical benefit | 0.05 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of LAG-3 | Clinical benefit | 0.01 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of LAG-3 | No clinical benefit | 1.33 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of LAG-3 | Clinical benefit | 0.01 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.07 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.08 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of LAG-3 | Clinical benefit | 0.20 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.33 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Baseline Expression of LAG-3 | Clinical benefit | 2.08 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.00 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of LAG-3 | Clinical benefit | 0.31 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.05 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.06 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of LAG-3 | Clinical benefit | 0.83 percent marker area expression of LAG-3 |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.03 percent marker area expression of LAG-3 |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.04 percent marker area expression of LAG-3 |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of LAG-3 | Clinical benefit | 0.35 percent marker area expression of LAG-3 |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of LAG-3 | Clinical benefit | 0.16 percent marker area expression of LAG-3 |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.43 percent marker area expression of LAG-3 |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of LAG-3 | No clinical benefit | 0.06 percent marker area expression of LAG-3 |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of LAG-3 | Clinical benefit | 0.04 percent marker area expression of LAG-3 |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of LAG-3 | Clinical benefit | 3.08 percent marker area expression of LAG-3 |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of LAG-3 | No clinical benefit | 1.98 percent marker area expression of LAG-3 |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of LAG-3 | Clinical benefit | 3.39 percent marker area expression of LAG-3 |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of LAG-3 | No clinical benefit | 0.57 percent marker area expression of LAG-3 |
Secondary
Baseline Expression of PD-L1
The tumor expression of programmed cell death-ligand 1 (PD-L1) was measured by immunohistochemical methods. This record summarizes the baseline expression of PD-1 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1.
Time frame: Screening
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab and had a valid assessment for the outcome measure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of PD-L1 | No clinical benefit | 5.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Baseline Expression of PD-L1 | No clinical benefit | 2.50 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of PD-L1 | No clinical benefit | 5.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of PD-L1 | No clinical benefit | 0.50 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of PD-L1 | Clinical benefit | 1.25 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Baseline Expression of PD-L1 | Clinical benefit | 5.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of PD-L1 | No clinical benefit | 2.50 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 5.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 40.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of PD-L1 | Clinical benefit | 10.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 60.00 PD-L1 positivity percentage |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of PD-L1 | Clinical benefit | 22.50 PD-L1 positivity percentage |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of PD-L1 | No clinical benefit | 0.00 PD-L1 positivity percentage |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of PD-L1 | Clinical benefit | 0.00 PD-L1 positivity percentage |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of PD-L1 | Clinical benefit | 80.0 PD-L1 positivity percentage |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of PD-L1 | No clinical benefit | 50.0 PD-L1 positivity percentage |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of PD-L1 | Clinical benefit | 7.75 PD-L1 positivity percentage |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of PD-L1 | No clinical benefit | 1.00 PD-L1 positivity percentage |
Secondary
Baseline Expression of TIM-3
The tumor expression of T-cell Immunoglobulin domain and Mucin domain-3 (TIM-3) was measured by immunohistochemical methods. This record summarizes the baseline expression of TIM-3 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1.
Time frame: Screening
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab and had a valid assessment for the outcome measure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of TIM-3 | No clinical benefit | 9.32 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Baseline Expression of TIM-3 | Clinical benefit | 3.01 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of TIM-3 | Clinical benefit | 2.56 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Baseline Expression of TIM-3 | No clinical benefit | 6.10 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of TIM-3 | No clinical benefit | 3.96 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Baseline Expression of TIM-3 | Clinical benefit | 6.68 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Baseline Expression of TIM-3 | No clinical benefit | 0.99 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Baseline Expression of TIM-3 | No clinical benefit | 10.93 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of TIM-3 | No clinical benefit | 0.88 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Baseline Expression of TIM-3 | Clinical benefit | 6.06 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of TIM-3 | No clinical benefit | 6.74 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Baseline Expression of TIM-3 | Clinical benefit | 41.00 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Baseline Expression of TIM-3 | No clinical benefit | 5.49 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Baseline Expression of TIM-3 | No clinical benefit | 4.82 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Baseline Expression of TIM-3 | No clinical benefit | 2.70 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Baseline Expression of TIM-3 | Clinical benefit | 1.05 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Baseline Expression of TIM-3 | No clinical benefit | 15.88 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of TIM-3 | Clinical benefit | 6.26 percent marker area expression of TIM-3 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Baseline Expression of TIM-3 | No clinical benefit | 2.36 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of TIM-3 | Clinical benefit | 4.19 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Baseline Expression of TIM-3 | No clinical benefit | 32.23 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of TIM-3 | Clinical benefit | 15.19 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Baseline Expression of TIM-3 | No clinical benefit | 47.27 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of TIM-3 | Clinical benefit | 0.04 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Baseline Expression of TIM-3 | No clinical benefit | 11.29 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Baseline Expression of TIM-3 | No clinical benefit | 7.27 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Baseline Expression of TIM-3 | No clinical benefit | 1.89 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of TIM-3 | No clinical benefit | 8.92 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Baseline Expression of TIM-3 | Clinical benefit | 0.66 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 2.13 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Baseline Expression of TIM-3 | Clinical benefit | 0.40 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 52.24 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 6.74 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Baseline Expression of TIM-3 | Clinical benefit | 7.13 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 0.84 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Baseline Expression of TIM-3 | Clinical benefit | 17.81 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 0.37 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Baseline Expression of TIM-3 | Clinical benefit | 11.27 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 2.88 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Baseline Expression of TIM-3 | Clinical benefit | 14.57 percent marker area expression of TIM-3 |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 0.71 percent marker area expression of TIM-3 |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of TIM-3 | Clinical benefit | 5.05 percent marker area expression of TIM-3 |
| Dose Ranging Part: MBG453 80mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 1.50 percent marker area expression of TIM-3 |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of TIM-3 | Clinical benefit | 2.32 percent marker area expression of TIM-3 |
| Dose Ranging Part: MBG453 240mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 2.16 percent marker area expression of TIM-3 |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of TIM-3 | Clinical benefit | 1.66 percent marker area expression of TIM-3 |
| Dose Ranging Part: MBG453 1200mg Q4W | Baseline Expression of TIM-3 | No clinical benefit | 6.20 percent marker area expression of TIM-3 |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of TIM-3 | No clinical benefit | 8.19 percent marker area expression of TIM-3 |
| Phase II: MBG453 + PDR001 NSCLC | Baseline Expression of TIM-3 | Clinical benefit | 7.78 percent marker area expression of TIM-3 |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of TIM-3 | No clinical benefit | 3.11 percent marker area expression of TIM-3 |
| Phase II: MBG453 + PDR001 Melanoma | Baseline Expression of TIM-3 | Clinical benefit | 28.92 percent marker area expression of TIM-3 |
Secondary
Best Overall Response (BOR) Per RECIST v1.1
BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per RECIST v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression; NCRNPD: Persistence of one or more non-target lesions. Number of participants in each category is reported in the table.
Time frame: From start of treatment until end of treatment, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 4 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 3 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 7 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 6 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 8 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 7 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 5 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 2 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 2 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 1 Participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 4 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 2 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 4 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 7 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 1 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 7 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 5 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 2 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 2 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 2 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 0 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 2 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 7 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 4 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 3 Participants |
| Dose Ranging Part: MBG453 80mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 2 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 13 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Dose Ranging Part: MBG453 240mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 4 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 3 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 8 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase II: MBG453 + PDR001 NSCLC | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase II: MBG453 + PDR001 NSCLC | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 6 Participants |
| Phase II: MBG453 + PDR001 NSCLC | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 5 Participants |
| Phase II: MBG453 + PDR001 NSCLC | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 6 Participants |
| Phase II: MBG453 + PDR001 NSCLC | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase II: MBG453 + PDR001 NSCLC | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase II: MBG453 + PDR001 Melanoma | Best Overall Response (BOR) Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase II: MBG453 + PDR001 Melanoma | Best Overall Response (BOR) Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase II: MBG453 + PDR001 Melanoma | Best Overall Response (BOR) Per RECIST v1.1 | Unknown | 1 Participants |
| Phase II: MBG453 + PDR001 Melanoma | Best Overall Response (BOR) Per RECIST v1.1 | Progressive Disease (PD) | 12 Participants |
| Phase II: MBG453 + PDR001 Melanoma | Best Overall Response (BOR) Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase II: MBG453 + PDR001 Melanoma | Best Overall Response (BOR) Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
Secondary
Duration of Response (DOR) Per RECIST v1.1
DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment according to RECIST v1.1. DOR is defined as the time from the date of first documented response to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, duration was censored at the date of last adequate tumor assessment. According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed CR or PR in each treatment group/arm.
Time frame: From first documented response to first documented disease progression or death due to underlying cancer, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
Population: All patients for whom best overall response is complete response (CR) or partial response (PR) per RECIST v1.1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Duration of Response (DOR) Per RECIST v1.1 | NA months |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Duration of Response (DOR) Per RECIST v1.1 | NA months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Duration of Response (DOR) Per RECIST v1.1 | NA months |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Duration of Response (DOR) Per RECIST v1.1 | NA months |
Secondary
Maximum Observed Serum Concentration (Cmax) of Sabatolimab
Pharmacokinetic (PK) parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time frame: pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure in each timepoint. PAS consists of all patients who have at least one blood sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 24.8 µg/mL | Standard Deviation 13.5 |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 23 µg/mL | Standard Deviation 6.28 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 144 µg/mL | Standard Deviation 60.8 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 81.3 µg/mL | Standard Deviation 24.4 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 251 µg/mL | Standard Deviation 57.3 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 420 µg/mL | Standard Deviation 138 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 429 µg/mL | Standard Deviation 152 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 563 µg/mL | — |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 36.1 µg/mL | Standard Deviation 0.919 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 74 µg/mL | Standard Deviation 8.59 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 443 µg/mL | Standard Deviation 190 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 321 µg/mL | Standard Deviation 64.2 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 443 µg/mL | Standard Deviation 4.24 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 709 µg/mL | — |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 116 µg/mL | Standard Deviation 28.6 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 98.8 µg/mL | Standard Deviation 50.8 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 271 µg/mL | Standard Deviation 78.5 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 333 µg/mL | Standard Deviation 39.6 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 448 µg/mL | — |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 304 µg/mL | Standard Deviation 86.5 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 713 µg/mL | Standard Deviation 14.8 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 457 µg/mL | Standard Deviation 135 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 12.7 µg/mL | Standard Deviation 16.8 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 7.68 µg/mL | Standard Deviation 3.68 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 40.2 µg/mL | Standard Deviation 31.1 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 23 µg/mL | Standard Deviation 6.38 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 101 µg/mL | Standard Deviation 25.6 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 83 µg/mL | Standard Deviation 20.7 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 58.3 µg/mL | Standard Deviation 12.7 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 45.4 µg/mL | — |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 379 µg/mL | Standard Deviation 104 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 213 µg/mL | Standard Deviation 4.19 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 189 µg/mL | Standard Deviation 70.6 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 422 µg/mL | Standard Deviation 49.5 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 25.8 µg/mL | Standard Deviation 5.22 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 22.9 µg/mL | Standard Deviation 5.91 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 23.3 µg/mL | Standard Deviation 0.529 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 18.6 µg/mL | Standard Deviation 0.99 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 77 µg/mL | Standard Deviation 27.2 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 72 µg/mL | Standard Deviation 18.3 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 104 µg/mL | Standard Deviation 32.5 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 59.7 µg/mL | Standard Deviation 30.2 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 79 µg/mL | Standard Deviation 26 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 102 µg/mL | Standard Deviation 32.5 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 286 µg/mL | Standard Deviation 60.8 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 254 µg/mL | Standard Deviation 38.7 |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 343 µg/mL | Standard Deviation 112 |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 557 µg/mL | — |
| Dose Ranging Part: MBG453 80mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 34.6 µg/mL | Standard Deviation 21.8 |
| Dose Ranging Part: MBG453 80mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 31.2 µg/mL | Standard Deviation 5.58 |
| Dose Ranging Part: MBG453 240mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 86.2 µg/mL | Standard Deviation 27 |
| Dose Ranging Part: MBG453 240mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 94.4 µg/mL | Standard Deviation 19.1 |
| Dose Ranging Part: MBG453 1200mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 394 µg/mL | Standard Deviation 86.7 |
| Dose Ranging Part: MBG453 1200mg Q4W | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 412 µg/mL | Standard Deviation 124 |
| Phase II: MBG453 + PDR001 NSCLC | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 185 µg/mL | Standard Deviation 64.6 |
| Phase II: MBG453 + PDR001 NSCLC | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 267 µg/mL | Standard Deviation 82.5 |
| Phase II: MBG453 + PDR001 Melanoma | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 3 | 316 µg/mL | Standard Deviation 105 |
| Phase II: MBG453 + PDR001 Melanoma | Maximum Observed Serum Concentration (Cmax) of Sabatolimab | Cycle 1 | 233 µg/mL | Standard Deviation 60.3 |
Secondary
Maximum Observed Serum Concentration (Cmax) of Spartalizumab
PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time frame: pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure in each timepoint. PAS consists of all patients who have at least one blood sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 21.3 µg/mL | Standard Deviation 14.9 |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 38.4 µg/mL | Standard Deviation 12 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 40.6 µg/mL | Standard Deviation 7.09 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 24.8 µg/mL | Standard Deviation 7.8 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 34.5 µg/mL | Standard Deviation 6.59 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 20.1 µg/mL | Standard Deviation 5.36 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 50 µg/mL | — |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 66.2 µg/mL | Standard Deviation 12.2 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 40.2 µg/mL | Standard Deviation 6.12 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 18.6 µg/mL | Standard Deviation 4.5 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 125 µg/mL | Standard Deviation 5.66 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 71.9 µg/mL | Standard Deviation 23.8 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 27 µg/mL | Standard Deviation 3.77 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 28.8 µg/mL | Standard Deviation 18.6 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 122 µg/mL | Standard Deviation 7.07 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 78.1 µg/mL | Standard Deviation 35.2 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 24.3 µg/mL | Standard Deviation 20.6 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 24 µg/mL | Standard Deviation 12.5 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 97 µg/mL | Standard Deviation 27.7 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 65.1 µg/mL | Standard Deviation 23.1 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 152 µg/mL | Standard Deviation 40.2 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 121 µg/mL | Standard Deviation 30 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 134 µg/mL | Standard Deviation 38.2 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 113 µg/mL | Standard Deviation 27 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 112 µg/mL | Standard Deviation 35.8 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 80.5 µg/mL | — |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 98.1 µg/mL | Standard Deviation 29.1 |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 143 µg/mL | Standard Deviation 46.5 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 3 | 174 µg/mL | Standard Deviation 63.5 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | Cycle 1 | 126 µg/mL | Standard Deviation 42.1 |
Secondary
Number of Participants With Anti-sabatolimab Antibodies
Immunogenicity was evaluated in serum in a validated three-tiered assay approach. Samples were screened for potential anti-sabatolimab antibodies and positive screen results were confirmed using a confirmatory assay. For confirmed anti-drug antibodies (ADA) positive samples, titers were determined. Patient ADA status was defined as follows: * ADA-negative at baseline: ADA-negative sample at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples * ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative * Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample * Treatment-boosted ADA-positive = ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample
Time frame: Baseline (before first dose) and post-baseline (assessed throughout the treatment up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab)
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab and had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample for assessing anti-sabatolimab antibodies. Determinant samples are defined as samples which are not unevaluable (where unevaluable = sample where assay is not available).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 3 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 3 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 5 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 3 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 8 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 7 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 14 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 14 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 5 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 5 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 2 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 3 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 4 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 6 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 6 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 2 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 5 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 6 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 7 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 5 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 5 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 6 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 6 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 6 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 5 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 7 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 12 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 5 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 3 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 4 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 1 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 5 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 2 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 4 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 4 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 1 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 4 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 4 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 3 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 5 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 2 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 1 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 1 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 10 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 12 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 4 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 5 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 1 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 3 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 4 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 1 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 5 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 6 participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 1 participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Dose Ranging Part: MBG453 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 9 participants |
| Dose Ranging Part: MBG453 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Dose Ranging Part: MBG453 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 8 participants |
| Dose Ranging Part: MBG453 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Dose Ranging Part: MBG453 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 2 participants |
| Dose Ranging Part: MBG453 80mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Dose Ranging Part: MBG453 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 0 participants |
| Dose Ranging Part: MBG453 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Dose Ranging Part: MBG453 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 7 participants |
| Dose Ranging Part: MBG453 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Dose Ranging Part: MBG453 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 12 participants |
| Dose Ranging Part: MBG453 240mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 5 participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 10 participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 1 participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 10 participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 2 participants |
| Phase II: MBG453 + PDR001 NSCLC | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase II: MBG453 + PDR001 NSCLC | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 1 participants |
| Phase II: MBG453 + PDR001 NSCLC | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 10 participants |
| Phase II: MBG453 + PDR001 NSCLC | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 1 participants |
| Phase II: MBG453 + PDR001 NSCLC | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 11 participants |
| Phase II: MBG453 + PDR001 NSCLC | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 1 participants |
| Phase II: MBG453 + PDR001 Melanoma | Number of Participants With Anti-sabatolimab Antibodies | ADA- inconclusive post-baseline | 14 participants |
| Phase II: MBG453 + PDR001 Melanoma | Number of Participants With Anti-sabatolimab Antibodies | ADA-positive at baseline | 1 participants |
| Phase II: MBG453 + PDR001 Melanoma | Number of Participants With Anti-sabatolimab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase II: MBG453 + PDR001 Melanoma | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative at baseline | 13 participants |
| Phase II: MBG453 + PDR001 Melanoma | Number of Participants With Anti-sabatolimab Antibodies | ADA-negative post-baseline | 0 participants |
| Phase II: MBG453 + PDR001 Melanoma | Number of Participants With Anti-sabatolimab Antibodies | Treatment-boosted ADA-positive | 0 participants |
Secondary
Number of Participants With Anti-spartalizumab Antibodies
Immunogenicity was evaluated in serum in a validated three-tiered assay approach. Samples were screened for potential anti-spartalizumab antibodies and positive screen results were confirmed using a confirmatory assay. For confirmed anti-drug antibodies (ADA) positive samples, titers were determined. Patient ADA status was defined as follows: * ADA-negative at baseline: ADA-negative sample at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples * ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative * Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample * Treatment-boosted ADA-positive = ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample
Time frame: Baseline (before first dose) and post-baseline (assessed throughout the treatment up to 4.9 years).
Population: All patients who received at least one full or partial dose of assigned combination sabatolimab+spartalizumab and had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample for assessing anti-spartalizumab antibodies. Determinant samples are defined as samples which are not unevaluable (where unevaluable = sample where assay is not available).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 4 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 2 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 3 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 9 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 7 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 3 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 1 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 4 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 5 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 4 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 3 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 4 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 4 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 1 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 5 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 3 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 2 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 7 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 9 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 3 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 4 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 2 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 3 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 4 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 6 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 1 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 1 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 2 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 3 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 6 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 6 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 12 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative at baseline | 13 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA- inconclusive post-baseline | 6 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA-negative post-baseline | 7 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Number of Participants With Anti-spartalizumab Antibodies | ADA-positive at baseline | 0 participants |
Secondary
Overall Response Rate (ORR) Per irRC
Tumor response was based on local investigator assessment as per irRC. ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of diameters.
Time frame: From start of treatment until end of treatment, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Overall Response Rate (ORR) Per irRC | 16.7 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Overall Response Rate (ORR) Per irRC | 7.7 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Overall Response Rate (ORR) Per irRC | 28.6 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Overall Response Rate (ORR) Per irRC | 16.7 Percentage of participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Dose Ranging Part: MBG453 80mg Q4W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Dose Ranging Part: MBG453 240mg Q4W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Dose Ranging Part: MBG453 1200mg Q4W | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase II: MBG453 + PDR001 NSCLC | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
| Phase II: MBG453 + PDR001 Melanoma | Overall Response Rate (ORR) Per irRC | 0 Percentage of participants |
Secondary
Overall Survival (OS)
OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. OS was estimated using Kaplan-Meier estimates.
Time frame: From start of treatment until death due to any cause, assessed up to 2 years for sabatolimab and 5.3 years for sabatolimab in combination with spartalizumab
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Overall Survival (OS) | 4.1 months |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Overall Survival (OS) | 6.7 months |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Overall Survival (OS) | 10.3 months |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Overall Survival (OS) | 4.3 months |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Overall Survival (OS) | 4.1 months |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Overall Survival (OS) | 4.2 months |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Overall Survival (OS) | 5.0 months |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Overall Survival (OS) | 8.5 months |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Overall Survival (OS) | 12.5 months |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Overall Survival (OS) | 2.5 months |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Overall Survival (OS) | 4.8 months |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Overall Survival (OS) | 6.6 months |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Overall Survival (OS) | 24.4 months |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Overall Survival (OS) | 10.0 months |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Overall Survival (OS) | 9.6 months |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Overall Survival (OS) | 3.1 months |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Overall Survival (OS) | 20.6 months |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Overall Survival (OS) | 5.4 months |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Overall Survival (OS) | NA months |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Overall Survival (OS) | 3.6 months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Overall Survival (OS) | 8.6 months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Overall Survival (OS) | 12.3 months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Overall Survival (OS) | 24.8 months |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Overall Survival (OS) | 18.0 months |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Overall Survival (OS) | 2.4 months |
| Dose Ranging Part: MBG453 80mg Q4W | Overall Survival (OS) | 4.0 months |
| Dose Ranging Part: MBG453 240mg Q4W | Overall Survival (OS) | 4.9 months |
| Dose Ranging Part: MBG453 1200mg Q4W | Overall Survival (OS) | 10.9 months |
| Phase II: MBG453 + PDR001 NSCLC | Overall Survival (OS) | 6.6 months |
| Phase II: MBG453 + PDR001 Melanoma | Overall Survival (OS) | 6.7 months |
Secondary
Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count
The count of TILs was performed by hematoxylin and eosin stain.
Time frame: Baseline (screening) and post-baseline (assessed throughout the treatment up to maximum 193 days)
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab and had a paired assessment at baseline and post-baseline for the outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | 41.67 percentage change from baseline |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -100.00 percentage change from baseline |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -25.00 percentage change from baseline |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -50.00 percentage change from baseline |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -70.00 percentage change from baseline |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -75.00 percentage change from baseline |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -66.67 percentage change from baseline |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -25.00 percentage change from baseline |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -50.00 percentage change from baseline |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -50.00 percentage change from baseline |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -97.50 percentage change from baseline |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -87.50 percentage change from baseline |
| Dose Ranging Part: MBG453 80mg Q4W | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -66.67 percentage change from baseline |
| Dose Ranging Part: MBG453 240mg Q4W | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | 550.00 percentage change from baseline |
| Phase II: MBG453 + PDR001 NSCLC | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -40.95 percentage change from baseline |
| Phase II: MBG453 + PDR001 Melanoma | Percentage Change From Baseline of Tumor Infiltrating Lymphocytes (TILs) Count | -48.43 percentage change from baseline |
Secondary
Phase II: Dose Intensity of Sabatolimab
Dose intensity of sabatolimab was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 2.9 years
Population: All patients in Phase II who received at least one full or partial dose of the combination sabatolimab+spartalizumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Dose Intensity of Sabatolimab | 772.94 milligrams | Standard Deviation 62.826 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Dose Intensity of Sabatolimab | 800.00 milligrams | Standard Deviation 0 |
Secondary
Phase II: Dose Intensity of Spartalizumab
Dose intensity of spartalizumab was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 2.9 years
Population: All patients in Phase II who received at least one full or partial dose of the combination sabatolimab+spartalizumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Dose Intensity of Spartalizumab | 386.47 milligrams | Standard Deviation 31.413 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Dose Intensity of Spartalizumab | 400.00 milligrams | Standard Deviation 0 |
Secondary
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
Time frame: From first dose of study medication up to 30 days after last dose, with a maximum duration of 3 years
Population: All patients in Phase II who received at least one full or partial dose of the combination sabatolimab+spartalizumab
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 16 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 10 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 6 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 2 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 2 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 4 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 15 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 9 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs requiring additional therapy | 14 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to dose adjustment/interruption | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 15 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 9 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs with grade ≥ 3 | 6 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs with grade ≥ 3 | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 2 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs leading to discontinuation | 1 Participants |
Secondary
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab
Number of participants with at least one dose reduction of sabatolimab and number of participants with at least one dose interruption of sabatolimab.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 2.9 years
Population: All patients in Phase II who received at least one full or partial dose of the combination sabatolimab+spartalizumab
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 3 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab | At least one dose interruption | 0 Participants |
Secondary
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab
Number of participants with at least one dose reduction of spartalizumab and number of participants with at least one dose interruption of spartalizumab.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 2.9 years
Population: All patients in Phase II who received at least one full or partial dose of the combination sabatolimab+spartalizumab
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 3 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose reduction | 0 Participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab | At least one dose interruption | 0 Participants |
Secondary
Progression-Free Survival (PFS) Per irRC
PFS is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor evaluation. Tumor response was based on local investigator assessment per irRC. PFS was analyzed using Kaplan-Meier estimates.
Time frame: From start of treatment until first documented and confirmed progression or death due to any cause, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Progression-Free Survival (PFS) Per irRC | 1.8 months |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Progression-Free Survival (PFS) Per irRC | 1.8 months |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Progression-Free Survival (PFS) Per irRC | 1.8 months |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Progression-Free Survival (PFS) Per irRC | 1.7 months |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Progression-Free Survival (PFS) Per irRC | 1.5 months |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Progression-Free Survival (PFS) Per irRC | 1.9 months |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Progression-Free Survival (PFS) Per irRC | 2.0 months |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Progression-Free Survival (PFS) Per irRC | 1.6 months |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Progression-Free Survival (PFS) Per irRC | 1.7 months |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Progression-Free Survival (PFS) Per irRC | 1.8 months |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Progression-Free Survival (PFS) Per irRC | 2.3 months |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Progression-Free Survival (PFS) Per irRC | 2.0 months |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Progression-Free Survival (PFS) Per irRC | 3.6 months |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Progression-Free Survival (PFS) Per irRC | 3.6 months |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Progression-Free Survival (PFS) Per irRC | 1.7 months |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Progression-Free Survival (PFS) Per irRC | 1.8 months |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Progression-Free Survival (PFS) Per irRC | 1.8 months |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Progression-Free Survival (PFS) Per irRC | 1.7 months |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Progression-Free Survival (PFS) Per irRC | 2.6 months |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Progression-Free Survival (PFS) Per irRC | 2.4 months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Progression-Free Survival (PFS) Per irRC | 2.3 months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Progression-Free Survival (PFS) Per irRC | 5.5 months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Progression-Free Survival (PFS) Per irRC | NA months |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Progression-Free Survival (PFS) Per irRC | 2.7 months |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Progression-Free Survival (PFS) Per irRC | 1.7 months |
| Dose Ranging Part: MBG453 80mg Q4W | Progression-Free Survival (PFS) Per irRC | 1.8 months |
| Dose Ranging Part: MBG453 240mg Q4W | Progression-Free Survival (PFS) Per irRC | 1.7 months |
| Dose Ranging Part: MBG453 1200mg Q4W | Progression-Free Survival (PFS) Per irRC | 1.7 months |
| Phase II: MBG453 + PDR001 NSCLC | Progression-Free Survival (PFS) Per irRC | 1.7 months |
| Phase II: MBG453 + PDR001 Melanoma | Progression-Free Survival (PFS) Per irRC | 1.8 months |
Secondary
Progression-Free Survival (PFS) Per RECIST v1.1
PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1. PFS was analyzed using Kaplan-Meier estimates.
Time frame: From start of treatment until first documented progression or death due to any cause, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.8 months |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.8 months |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.8 months |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.7 months |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.5 months |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.9 months |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Progression-Free Survival (PFS) Per RECIST v1.1 | 2.0 months |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.6 months |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.7 months |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.7 months |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.8 months |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Progression-Free Survival (PFS) Per RECIST v1.1 | 2.0 months |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Progression-Free Survival (PFS) Per RECIST v1.1 | 3.6 months |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Progression-Free Survival (PFS) Per RECIST v1.1 | 3.6 months |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.7 months |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.8 months |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.8 months |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.7 months |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | 2.6 months |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | 2.4 months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.8 months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | 3.5 months |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | 2.7 months |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.7 months |
| Dose Ranging Part: MBG453 80mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.8 months |
| Dose Ranging Part: MBG453 240mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.7 months |
| Dose Ranging Part: MBG453 1200mg Q4W | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.7 months |
| Phase II: MBG453 + PDR001 NSCLC | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.7 months |
| Phase II: MBG453 + PDR001 Melanoma | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.8 months |
Secondary
Terminal Elimination Half-life (T1/2) of Sabatolimab
PK parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. T1/2 was calculated by regression analysis of the terminal elimination phase. T1/2 was computed as 0.693/terminal elimination rate constant.
Time frame: pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure in each timepoint. PAS consists of all patients who have at least one blood sample providing evaluable PK data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Terminal Elimination Half-life (T1/2) of Sabatolimab | 8.6 days | Standard Deviation 4.9 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Terminal Elimination Half-life (T1/2) of Sabatolimab | 16.5 days | Standard Deviation 6.61 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Terminal Elimination Half-life (T1/2) of Sabatolimab | 13.5 days | Standard Deviation 5.1 |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Terminal Elimination Half-life (T1/2) of Sabatolimab | 33.8 days | — |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Terminal Elimination Half-life (T1/2) of Sabatolimab | 12.1 days | Standard Deviation 2.35 |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Terminal Elimination Half-life (T1/2) of Sabatolimab | 23.3 days | Standard Deviation 11.1 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Terminal Elimination Half-life (T1/2) of Sabatolimab | 13.7 days | Standard Deviation 1.8 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Terminal Elimination Half-life (T1/2) of Sabatolimab | 6.38 days | — |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Terminal Elimination Half-life (T1/2) of Sabatolimab | 14.3 days | Standard Deviation 13 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 17.5 days | — |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 13.7 days | Standard Deviation 11.6 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 16.5 days | Standard Deviation 7.69 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 17.6 days | Standard Deviation 0.142 |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 14.9 days | Standard Deviation 6.72 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 6.46 days | Standard Deviation 1.55 |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 6.8 days | — |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 11.2 days | Standard Deviation 5.27 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 16.4 days | Standard Deviation 7.48 |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 11.6 days | Standard Deviation 3.66 |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 13.9 days | Standard Deviation 1.48 |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 11.5 days | — |
| Dose Ranging Part: MBG453 80mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 5.85 days | Standard Deviation 1.77 |
| Dose Ranging Part: MBG453 240mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 12 days | Standard Deviation 4.33 |
| Dose Ranging Part: MBG453 1200mg Q4W | Terminal Elimination Half-life (T1/2) of Sabatolimab | 12.9 days | Standard Deviation 5.62 |
| Phase II: MBG453 + PDR001 NSCLC | Terminal Elimination Half-life (T1/2) of Sabatolimab | 19.1 days | Standard Deviation 8.69 |
| Phase II: MBG453 + PDR001 Melanoma | Terminal Elimination Half-life (T1/2) of Sabatolimab | 21.7 days | Standard Deviation 2.14 |
Secondary
Terminal Elimination Half-life (T1/2) of Spartalizumab
PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. T1/2 was calculated by regression analysis of the terminal elimination phase. T1/2 was computed as 0.693/terminal elimination rate constant.
Time frame: pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure in each timepoint. PAS consists of all patients who have at least one blood sample providing evaluable PK data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Terminal Elimination Half-life (T1/2) of Spartalizumab | 13.7 days | Standard Deviation 6.46 |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Terminal Elimination Half-life (T1/2) of Spartalizumab | 19.9 days | Standard Deviation 13.9 |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Terminal Elimination Half-life (T1/2) of Spartalizumab | 29.5 days | Standard Deviation 19.4 |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Terminal Elimination Half-life (T1/2) of Spartalizumab | 13.2 days | Standard Deviation 1.14 |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Terminal Elimination Half-life (T1/2) of Spartalizumab | 17.4 days | Standard Deviation 9.53 |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Terminal Elimination Half-life (T1/2) of Spartalizumab | 30.6 days | Standard Deviation 23.5 |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Terminal Elimination Half-life (T1/2) of Spartalizumab | 32.1 days | — |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Terminal Elimination Half-life (T1/2) of Spartalizumab | 15.7 days | Standard Deviation 5.6 |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Terminal Elimination Half-life (T1/2) of Spartalizumab | 23.6 days | Standard Deviation 8.82 |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Terminal Elimination Half-life (T1/2) of Spartalizumab | 24.3 days | Standard Deviation 9.72 |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Terminal Elimination Half-life (T1/2) of Spartalizumab | 22.9 days | Standard Deviation 6.19 |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Terminal Elimination Half-life (T1/2) of Spartalizumab | 28.7 days | — |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Terminal Elimination Half-life (T1/2) of Spartalizumab | 24.5 days | Standard Deviation 11.8 |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Terminal Elimination Half-life (T1/2) of Spartalizumab | 22.7 days | Standard Deviation 3.15 |
Secondary
Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab
PK parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time frame: pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure in each timepoint. PAS consists of all patients who have at least one blood sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.53 hours |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.54 hours |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.58 hours |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.5 hours |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.57 hours |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.53 hours |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.7 hours |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.53 hours |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.57 hours |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.57 hours |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.55 hours |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.56 hours |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.62 hours |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.53 hours |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.58 hours |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.21 hours |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.5 hours |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.63 hours |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.5 hours |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.53 hours |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.57 hours |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.55 hours |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 4 hours |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.25 hours |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.31 hours |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.08 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.13 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.09 hours |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.08 hours |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.2 hours |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.48 hours |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.04 hours |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.32 hours |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.38 hours |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3 hours |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.17 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.13 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.04 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.25 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.21 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.08 hours |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.08 hours |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3 hours |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.5 hours |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.23 hours |
| Dose Ranging Part: MBG453 80mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.5 hours |
| Dose Ranging Part: MBG453 80mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.58 hours |
| Dose Ranging Part: MBG453 240mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.58 hours |
| Dose Ranging Part: MBG453 240mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.58 hours |
| Dose Ranging Part: MBG453 1200mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 1.58 hours |
| Dose Ranging Part: MBG453 1200mg Q4W | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 1.67 hours |
| Phase II: MBG453 + PDR001 NSCLC | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.37 hours |
| Phase II: MBG453 + PDR001 NSCLC | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.08 hours |
| Phase II: MBG453 + PDR001 Melanoma | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 1 | 3.15 hours |
| Phase II: MBG453 + PDR001 Melanoma | Time to Reach Maximum Serum Concentration (Tmax) of Sabatolimab | Cycle 3 | 3.24 hours |
Secondary
Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab
PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time frame: pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
Population: Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure in each timepoint. PAS consists of all patients who have at least one blood sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.67 hours |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.78 hours |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.5 hours |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.58 hours |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.83 hours |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.58 hours |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.63 hours |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.58 hours |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.57 hours |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.67 hours |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 13 hours |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.61 hours |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.72 hours |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.5 hours |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.58 hours |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.63 hours |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.5 hours |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.52 hours |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.53 hours |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.58 hours |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.65 hours |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.5 hours |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.5 hours |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.58 hours |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 165 hours |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.58 hours |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.58 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 3 | 1.56 hours |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | Cycle 1 | 1.58 hours |
Post Hoc
All-Collected Deaths
On-treatment and post-treatment safety follow-up deaths were collected from first dose of study medication to 30 days after last dose (sabatolimab single agent) and to 150 days after last dose (sabatolimab+spartalizumab). Survival follow-up deaths were collected from 31 days (sabatolimab) and 151 days (sabatolimab+spartalizumab) after last dose until end of study. All deaths refer to the sum of on-treatment and post-treatment safety follow-up deaths plus survival follow-up deaths.
Time frame: On-treatment and post-treatment safety follow-up deaths: up to 2 years for sabatolimab and 5.3 years for sabatolimab + spartalizumab. Survival follow-up deaths: up to 2 years for sabatolimab and 5.3 years for sabatolimab + spartalizumab
Population: All patients who received at least one dose of assigned single agent sabatolimab, or at least one full or partial dose of assigned combination sabatolimab+spartalizumab
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 9 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W ROW | All-Collected Deaths | All deaths | 12 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | All-Collected Deaths | All deaths | 8 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | All-Collected Deaths | Survival follow-up deaths | 4 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W ROW | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 4 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | All-Collected Deaths | All deaths | 13 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 6 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W ROW | All-Collected Deaths | Survival follow-up deaths | 7 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 5 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W ROW | All-Collected Deaths | All deaths | 5 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 1 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | All-Collected Deaths | Survival follow-up deaths | 1 participants |
| Phase I Dose Escalation: MBG453 80mg Q2W Japan | All-Collected Deaths | All deaths | 2 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | All-Collected Deaths | All deaths | 4 participants |
| Phase I Dose Escalation: MBG453 240mg Q2W Japan | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 4 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | All-Collected Deaths | Survival follow-up deaths | 1 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 5 participants |
| Phase I Dose Escalation: MBG453 800mg Q2W Japan | All-Collected Deaths | All deaths | 6 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | All-Collected Deaths | All deaths | 2 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 1 participants |
| Phase I Dose Escalation: MBG453 1200mg Q2W Japan | All-Collected Deaths | Survival follow-up deaths | 1 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | All-Collected Deaths | All deaths | 6 participants |
| Phase I Dose Escalation: MBG453 240mg Q4W ROW | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 3 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | All-Collected Deaths | All deaths | 7 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 4 participants |
| Phase I Dose Escalation: MBG453 800mg Q4W ROW | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 4 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | All-Collected Deaths | Survival follow-up deaths | 1 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W ROW | All-Collected Deaths | All deaths | 5 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | All-Collected Deaths | All deaths | 6 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I Dose Escalation: MBG453 1200mg Q4W Japan | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 3 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 1 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | All deaths | 3 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 5 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | All deaths | 9 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | Survival follow-up deaths | 4 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | All deaths | 5 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | All-Collected Deaths | All deaths | 5 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 5 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W | All-Collected Deaths | All deaths | 4 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 3 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W | All-Collected Deaths | All deaths | 5 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | All-Collected Deaths | All deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 0 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 3 participants |
| Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | All deaths | 3 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | All-Collected Deaths | All deaths | 11 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | All-Collected Deaths | Survival follow-up deaths | 6 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 5 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | All-Collected Deaths | All deaths | 4 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | All deaths | 4 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 1 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | All deaths | 4 participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 4 participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | Survival follow-up deaths | 1 participants |
| Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W | All-Collected Deaths | All deaths | 5 participants |
| Dose Ranging Part: MBG453 80mg Q4W | All-Collected Deaths | All deaths | 12 participants |
| Dose Ranging Part: MBG453 80mg Q4W | All-Collected Deaths | Survival follow-up deaths | 4 participants |
| Dose Ranging Part: MBG453 80mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 8 participants |
| Dose Ranging Part: MBG453 240mg Q4W | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Dose Ranging Part: MBG453 240mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 9 participants |
| Dose Ranging Part: MBG453 240mg Q4W | All-Collected Deaths | All deaths | 12 participants |
| Dose Ranging Part: MBG453 1200mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 6 participants |
| Dose Ranging Part: MBG453 1200mg Q4W | All-Collected Deaths | Survival follow-up deaths | 7 participants |
| Dose Ranging Part: MBG453 1200mg Q4W | All-Collected Deaths | All deaths | 13 participants |
| Phase II: MBG453 + PDR001 NSCLC | All-Collected Deaths | All deaths | 17 participants |
| Phase II: MBG453 + PDR001 NSCLC | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 9 participants |
| Phase II: MBG453 + PDR001 NSCLC | All-Collected Deaths | Survival follow-up deaths | 8 participants |
| Phase II: MBG453 + PDR001 Melanoma | All-Collected Deaths | Survival follow-up deaths | 7 participants |
| Phase II: MBG453 + PDR001 Melanoma | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 6 participants |
| Phase II: MBG453 + PDR001 Melanoma | All-Collected Deaths | All deaths | 13 participants |