Advanced Solid Tumors
Conditions
Keywords
Non-small cell lung cancer, Melanoma, Renal cancer, Mesothelioma, Triple Negative Breast, TNBC, Renal
Brief summary
This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation (phase 1) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion (phase 2) which characterized treatment of LAG525 in combination with PDR001 at the MTD or RP2D.
Detailed description
This was a Phase 1/2, multi-center, open-label study comprising a Phase 1 dose escalation part followed by a Phase 2 dose expansion part. During the Phase 1 dose escalation part patients with any advanced solid tumor received the study treatment until the MTD was reached or a lower RP2D was established. The study had the following 3 dose escalation parts: 1) Single-agent LAG525; 2) Single-agent LAG525 in Japanese patients; 3) Combination of LAG525 with PDR001. Once the RP2D or MTD had been determined in the escalation parts, additional patients were to be enrolled in the Phase 2 expansion parts in order to assess the preliminary anti-tumor activity. Phase 2 expansion cohorts testing single-agent LAG525 were not opened for enrollment based on emerging data including but not limited to preliminary anti-tumor activity. Phase 2 expansion cohorts for the combination of LAG525 with PDR001 were opened and 5 tumor types were assessed: 1) Non-small cell lung cancer (NSCLC); 2) Melanoma; 3) Renal cell cancer (RCC); 4) Mesothelioma; 5) Triple negative breast cancer (TNBC). The efficacy and safety of the combination of LAG525 with PDR001 in these tumor types was assessed in both the PD-1/PD-L1 pre-treated and naïve settings.
Interventions
DRUGLAG525
LAG525 was administered via intravenous (i.v.) infusion
DRUGPDR001
PDR001 was administered via i.v. infusion
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
Phase I part: \- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists Phase II part: * Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression following their last prior therapy and fit into one of the following groups: * Group 1: NSCLC * Group 2: Melanoma * Group 3: Renal cancer * Group 4: Mesothelioma * Group 5: TNBC * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy.
Exclusion criteria
* History of severe hypersensitivity reactions to study treatment ingredients or other mAbs * Active, known or suspected autoimmune disease * Active infection requiring systemic antibiotic therapy * HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Patients receiving chronic treatment with systemic steroid therapy, other than replacement-dose corticosteroids in the setting of adrenal insufficiency * Patients receiving systemic treatment with any immunosuppressive medication * Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment * Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. * Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks * History of drug-induced pneumonitis or current pneumonitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms | 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 having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. |
| Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | From start of treatment until end of treatment, assessed up to 2.6 years | Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 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 diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 4.4 years. | Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable. |
| Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 2.6 years. | Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type. |
| Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 4.4 years. | Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). Japanese patients were not treated with PDR001 and therefore the RDI of this study drug is not applicable. |
| Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 2.6 years. | Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). The RDI of both study drugs is reported for each tumor type. |
| Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 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. |
| Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 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. |
| Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. |
| Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. |
| Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. |
| Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. |
| Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable. |
| Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on PDR001 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. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable. |
| Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on PDR001 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. |
| Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable. |
| Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. |
| Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable. |
| Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. |
| Phase 1: Number of Participants With Anti-LAG525 Antibodies | Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years). | Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record. |
| Phase 2: Number of Participants With Anti-LAG525 Antibodies | Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years). | Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record. |
| Phase 1: Number of Participants With Anti-PDR001 Antibodies | Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years). | Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record. |
| Phase 2: Number of Participants With Anti-PDR001 Antibodies | Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years). | Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record. |
| Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | From start of treatment until end of treatment, assessed up to 4.4 years | Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 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 diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients. |
| Phase 1: Overall Response Rate (ORR) Per irRC | From start of treatment until end of treatment, assessed up to 4.4 years | TTumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (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 target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients. |
| Phase 2: Overall Response Rate (ORR) Per irRC | From start of treatment until end of treatment, assessed up to 2.6 years | Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (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 target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type. |
| Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | From start of treatment until end of treatment, assessed up to 4.4 years | Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). 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; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients. |
| Phase 1: Disease Control Rate (DCR) Per irRC | From start of treatment until end of treatment, assessed up to 4.4 years | Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). 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 target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients. |
| Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | From start of treatment until end of treatment, assessed up to 2.6 years | Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). 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; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type. |
| Phase 2: Disease Control Rate (DCR) Per irRC | From start of treatment until end of treatment, assessed up to 2.6 years | Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). 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 target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type. |
| Phase 1: Duration of Response (DOR) Per RECIST 1.1 | From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years | DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. |
| Phase 1: Duration of Response (DOR) Per irRC | From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 4.4 years | DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. |
| Phase 2: Duration of Response (DOR) Per RECIST 1.1 | From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 2.6 years | DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. DOR is reported by tumor type. |
| Phase 2: Duration of Response (DOR) Per irRC | From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years | DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. DOR is reported by tumor type. |
| Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years. | Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record. |
| Phase 1: Progression-free Survival (PFS) Per irRC | From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years | PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported for ROW and Japanese patients. |
| Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years | PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported by tumor type. |
| Phase 2: Progression-free Survival (PFS) Per irRC | From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years | PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported by tumor type. |
| Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years | PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported for ROW and Japanese patients. |
| Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years. | Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants with AEs and SAEs is reported for each tumor type. |
Countries
Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Singapore, Spain, Taiwan, United States
Participant flow
Recruitment details
Participants took part in 25 investigative sites in 12 countries.
Pre-assignment details
The screening period began once patients had signed the study informed consent. All screening/baseline evaluations were performed ≤ 21 days before Cycle 1 Day 1, except for baseline radiological evaluations which had to be done within 28 days.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W Single-agent LAG525 1 mg/kg Q2W | 17 |
| Phase 1: LAG525 3 mg/kg Q2W Single-agent LAG525 3 mg/kg Q2W | 12 |
| Phase 1: LAG525 5 mg/kg Q2W Single-agent LAG525 5 mg/kg Q2W | 6 |
| Phase 1: LAG525 10 mg/kg Q2W Single-agent LAG525 10 mg/kg Q2W | 6 |
| Phase 1: LAG525 15 mg/kg Q2W Single-agent LAG525 15 mg/kg Q2W | 6 |
| Phase 1: LAG525 240 mg Q2W Single-agent LAG525 240 mg Q2W | 30 |
| Phase 1: LAG525 400 mg Q2W Single-agent LAG525 400 mg Q2W | 30 |
| Phase 1: LAG525 3 mg/kg Q4W Single-agent LAG525 3 mg/kg Q4W | 5 |
| Phase 1: LAG525 5 mg/kg Q4W Single-agent LAG525 5 mg/kg Q4W | 6 |
| Phase 1: LAG525 10 mg/kg Q4W Single-agent LAG525 10 mg/kg Q4W | 11 |
| Phase 1: LAG525 400 mg Q4W Single-agent LAG525 400 mg Q4W | 5 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W) | 6 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W) | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W) | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W) | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W) | 6 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W) | 20 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) | 6 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W) | 12 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W) | 7 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W) | 6 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W) | 12 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W) | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W) | 11 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W) | 6 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W) | 6 |
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1 | 121 |
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1 | 21 |
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1 | 93 |
| Total | 490 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 11 | 1 | 6 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 5 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 1 | 1 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 14 | 1 | 6 |
| Overall Study | Progressive disease | 15 | 11 | 5 | 6 | 3 | 26 | 28 | 4 | 5 | 9 | 5 | 4 | 5 | 4 | 5 | 5 | 15 | 3 | 8 | 3 | 4 | 9 | 4 | 11 | 4 | 5 | 85 | 17 | 77 |
| Overall Study | Subject/guardian decision | 2 | 0 | 1 | 0 | 2 | 2 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 6 | 2 | 3 |
Baseline characteristics
| Characteristic | Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: LAG525 400 mg Q4W | Phase 1: LAG525 1 mg/kg Q2W | Phase 1: LAG525 3 mg/kg Q2W | Phase 1: LAG525 5 mg/kg Q2W | Phase 1: LAG525 10 mg/kg Q2W | Phase 1: LAG525 15 mg/kg Q2W | Phase 1: LAG525 240 mg Q2W | Phase 1: LAG525 400 mg Q2W | Phase 1: LAG525 3 mg/kg Q4W | Phase 1: LAG525 5 mg/kg Q4W | Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: LAG525 10 mg/kg Q4W | Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 10.03 | 60.4 years STANDARD_DEVIATION 7.16 | 56.1 years STANDARD_DEVIATION 12.55 | 64.5 years STANDARD_DEVIATION 12.43 | 61.8 years STANDARD_DEVIATION 13.32 | 53.3 years STANDARD_DEVIATION 20.76 | 61.2 years STANDARD_DEVIATION 9.58 | 57.2 years STANDARD_DEVIATION 10.94 | 56.7 years STANDARD_DEVIATION 10.82 | 60.8 years STANDARD_DEVIATION 9.36 | 54.8 years STANDARD_DEVIATION 17.26 | 54.3 years STANDARD_DEVIATION 8.78 | 58.0 years STANDARD_DEVIATION 5.9 | 44.8 years STANDARD_DEVIATION 5.23 | 59.5 years STANDARD_DEVIATION 7.16 | 48.7 years STANDARD_DEVIATION 24.36 | 59.1 years STANDARD_DEVIATION 12.83 | 61.2 years STANDARD_DEVIATION 11.34 | 61.3 years STANDARD_DEVIATION 8.25 | 51.1 years STANDARD_DEVIATION 12.03 | 59.8 years STANDARD_DEVIATION 8.11 | 51.8 years STANDARD_DEVIATION 12.1 | 59.2 years STANDARD_DEVIATION 5.42 | 56.6 years STANDARD_DEVIATION 10.31 | 60.7 years STANDARD_DEVIATION 6.89 | 52.3 years STANDARD_DEVIATION 12.5 | 61.0 years STANDARD_DEVIATION 10.79 | 49.4 years STANDARD_DEVIATION 8.94 | 58.4 years STANDARD_DEVIATION 11.18 | 58.1 years STANDARD_DEVIATION 11.49 |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 8 Participants | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 10 Participants | 10 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 48 Participants | 4 Participants | 17 Participants | 122 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 4 Participants | 3 Participants | 8 Participants | 9 Participants | 5 Participants | 3 Participants | 6 Participants | 20 Participants | 20 Participants | 2 Participants | 4 Participants | 2 Participants | 6 Participants | 6 Participants | 10 Participants | 5 Participants | 20 Participants | 6 Participants | 10 Participants | 7 Participants | 4 Participants | 8 Participants | 5 Participants | 9 Participants | 5 Participants | 6 Participants | 69 Participants | 15 Participants | 70 Participants | 347 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Pacific Islander | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 7 Participants | 6 Participants | 3 Participants | 4 Participants | 4 Participants | 17 Participants | 14 Participants | 2 Participants | 4 Participants | 3 Participants | 3 Participants | 2 Participants | 6 Participants | 3 Participants | 9 Participants | 3 Participants | 11 Participants | 3 Participants | 3 Participants | 7 Participants | 5 Participants | 6 Participants | 4 Participants | 3 Participants | 53 Participants | 20 Participants | 40 Participants | 248 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 10 Participants | 6 Participants | 3 Participants | 2 Participants | 2 Participants | 13 Participants | 16 Participants | 3 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 5 Participants | 3 Participants | 11 Participants | 3 Participants | 1 Participants | 4 Participants | 3 Participants | 5 Participants | 1 Participants | 5 Participants | 2 Participants | 3 Participants | 68 Participants | 1 Participants | 53 Participants | 242 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 13 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 5 / 25 | 3 / 24 | 0 / 4 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 6 | 1 / 11 | 0 / 5 | 0 / 6 | 0 / 6 | 1 / 6 | 1 / 5 | 0 / 6 | 1 / 20 | 0 / 6 | 2 / 12 | 1 / 7 | 0 / 6 | 1 / 12 | 0 / 6 | 0 / 11 | 1 / 6 | 1 / 6 | 1 / 20 | 3 / 20 | 2 / 19 | 1 / 41 | 1 / 21 | 1 / 21 | 1 / 22 | 1 / 22 | 0 / 19 | 2 / 16 | 1 / 14 | 33 / 490 |
| other Total, other adverse events | 13 / 13 | 11 / 12 | 6 / 6 | 6 / 6 | 6 / 6 | 24 / 25 | 24 / 24 | 4 / 4 | 5 / 5 | 6 / 6 | 5 / 5 | 6 / 6 | 11 / 11 | 5 / 5 | 6 / 6 | 6 / 6 | 6 / 6 | 5 / 5 | 6 / 6 | 19 / 20 | 5 / 6 | 12 / 12 | 7 / 7 | 6 / 6 | 12 / 12 | 6 / 6 | 11 / 11 | 6 / 6 | 6 / 6 | 19 / 20 | 17 / 20 | 19 / 19 | 41 / 41 | 21 / 21 | 21 / 21 | 21 / 22 | 22 / 22 | 19 / 19 | 16 / 16 | 14 / 14 | 481 / 490 |
| serious Total, serious adverse events | 4 / 13 | 2 / 12 | 5 / 6 | 2 / 6 | 3 / 6 | 10 / 25 | 11 / 24 | 0 / 4 | 2 / 5 | 0 / 6 | 2 / 5 | 4 / 6 | 5 / 11 | 2 / 5 | 3 / 6 | 2 / 6 | 3 / 6 | 3 / 5 | 1 / 6 | 9 / 20 | 3 / 6 | 6 / 12 | 4 / 7 | 5 / 6 | 5 / 12 | 2 / 6 | 5 / 11 | 4 / 6 | 4 / 6 | 13 / 20 | 8 / 20 | 14 / 19 | 15 / 41 | 9 / 21 | 10 / 21 | 7 / 22 | 8 / 22 | 5 / 19 | 4 / 16 | 4 / 14 | 208 / 490 |
Outcome results
Primary
Phase 1: 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 having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Time frame: 15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001, and who either completed a minimum exposure requirement or who had a DLT during the first 15 days of treatment (1 cycle) for single-agent LAG525 arms or the first 30 days (2 cycles) for the LAG525 + PDR001 arms.~Japanese patients were analyzed together with the rest of the world (ROW) patients as per protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 1 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 2 Participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 1 Participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 1 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 1 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 1 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 1 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
Primary
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 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 diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type.
Time frame: From start of treatment until end of treatment, assessed up to 2.6 years
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Mesothelioma | 17.1 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Renal cell cancer (RCC) | 26.3 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | 14.3 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Melanoma | 15.0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Non-small cell lung cancer (NSCLC) | 15.0 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | 4.8 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | 0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Melanoma | 9.1 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Non-small cell lung cancer (NSCLC) | 0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Renal cell cancer (RCC) | 5.3 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | Mesothelioma | 6.3 percentage of participants |
Secondary
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 136 day*ug/mL | Standard Deviation 49.2 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 264 day*ug/mL | Standard Deviation 146 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, Japanese patients | 144 day*ug/mL | Standard Deviation 35.6 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, Japanese patients | 89.6 day*ug/mL | Standard Deviation 76.7 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 1000 day*ug/mL | Standard Deviation 358 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 506 day*ug/mL | Standard Deviation 111 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 758 day*ug/mL | Standard Deviation 172 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 2470 day*ug/mL | — |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 1830 day*ug/mL | Standard Deviation 627 |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 2330 day*ug/mL | — |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 5270 day*ug/mL | Standard Deviation 1250 |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 2810 day*ug/mL | Standard Deviation 555 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, Japanese patients | 1720 day*ug/mL | — |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 500 day*ug/mL | Standard Deviation 147 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, Japanese patients | 679 day*ug/mL | Standard Deviation 142 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 862 day*ug/mL | Standard Deviation 583 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 708 day*ug/mL | Standard Deviation 199 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 1390 day*ug/mL | Standard Deviation 759 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, Japanese patients | 2520 day*ug/mL | Standard Deviation 359 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, Japanese patients | 1130 day*ug/mL | Standard Deviation 153 |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 631 day*ug/mL | Standard Deviation 184 |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 928 day*ug/mL | Standard Deviation 469 |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 1220 day*ug/mL | Standard Deviation 491 |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 1200 day*ug/mL | Standard Deviation 754 |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 2230 day*ug/mL | Standard Deviation 731 |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 1770 day*ug/mL | Standard Deviation 2230 |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 1290 day*ug/mL | Standard Deviation 537 |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 2740 day*ug/mL | Standard Deviation 2680 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 35.8 day*ug/mL | Standard Deviation 10.5 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 59.9 day*ug/mL | Standard Deviation 39.3 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 174 day*ug/mL | Standard Deviation 31.3 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 286 day*ug/mL | Standard Deviation 134 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 264 day*ug/mL | Standard Deviation 133 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 138 day*ug/mL | Standard Deviation 38.9 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 162 day*ug/mL | Standard Deviation 56.5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 234 day*ug/mL | Standard Deviation 108 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 588 day*ug/mL | Standard Deviation 196 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 1310 day*ug/mL | Standard Deviation 701 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 869 day*ug/mL | Standard Deviation 328 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 608 day*ug/mL | Standard Deviation 165 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 952 day*ug/mL | Standard Deviation 441 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 1410 day*ug/mL | Standard Deviation 831 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 1640 day*ug/mL | Standard Deviation 539 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 1990 day*ug/mL | Standard Deviation 1180 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 336 day*ug/mL | Standard Deviation 439 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 198 day*ug/mL | Standard Deviation 101 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 1040 day*ug/mL | Standard Deviation 183 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 2250 day*ug/mL | Standard Deviation 44.7 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 2890 day*ug/mL | Standard Deviation 982 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 3840 day*ug/mL | Standard Deviation 1600 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 3020 day*ug/mL | Standard Deviation 928 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 7160 day*ug/mL | Standard Deviation 3190 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 150 day*ug/mL | Standard Deviation 61.6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 211 day*ug/mL | Standard Deviation 150 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 484 day*ug/mL | Standard Deviation 173 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 938 day*ug/mL | Standard Deviation 141 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, ROW patients | 1230 day*ug/mL | Standard Deviation 617 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, ROW patients | 551 day*ug/mL | Standard Deviation 205 |
Secondary
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 114 day*ug/mL | Standard Deviation 17 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 292 day*ug/mL | Standard Deviation 131 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 268 day*ug/mL | Standard Deviation 151 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 141 day*ug/mL | Standard Deviation 45.4 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 289 day*ug/mL | Standard Deviation 196 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 134 day*ug/mL | Standard Deviation 25.7 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 816 day*ug/mL | Standard Deviation 472 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 437 day*ug/mL | Standard Deviation 177 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 466 day*ug/mL | Standard Deviation 159 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 1340 day*ug/mL | Standard Deviation 673 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 1180 day*ug/mL | Standard Deviation 447 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 601 day*ug/mL | Standard Deviation 238 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 537 day*ug/mL | Standard Deviation 163 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 1020 day*ug/mL | Standard Deviation 563 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 637 day*ug/mL | Standard Deviation 263 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 939 day*ug/mL | Standard Deviation 572 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 591 day*ug/mL | Standard Deviation 207 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 1500 day*ug/mL | Standard Deviation 1450 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 789 day*ug/mL | Standard Deviation 319 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 1860 day*ug/mL | Standard Deviation 150 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 1950 day*ug/mL | Standard Deviation 645 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 1290 day*ug/mL | Standard Deviation 441 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 1190 day*ug/mL | Standard Deviation 353 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 2840 day*ug/mL | Standard Deviation 531 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 1440 day*ug/mL | Standard Deviation 828 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 1080 day*ug/mL | Standard Deviation 412 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 1110 day*ug/mL | Standard Deviation 335 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 1510 day*ug/mL | Standard Deviation 874 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, ROW patients | 950 day*ug/mL | Standard Deviation 264 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, ROW patients | 1310 day*ug/mL | Standard Deviation 700 |
Secondary
Phase 1: Disease Control Rate (DCR) Per irRC
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). 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 target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients.
Time frame: From start of treatment until end of treatment, assessed up to 4.4 years
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 30.8 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | Japanese | 25.0 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 50.0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | Japanese | 40.0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 28.0 percentage of participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | Japanese | 16.7 percentage of participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 20.0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 18.2 percentage of participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 20.0 percentage of participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 50.0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 66.7 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 50.0 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 60.0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 55.0 percentage of participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 50.0 percentage of participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 8.3 percentage of participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 28.6 percentage of participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 66.7 percentage of participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 50.0 percentage of participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 36.4 percentage of participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 50.0 percentage of participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per irRC | ROW | 50.0 percentage of participants |
Secondary
Phase 1: Disease Control Rate (DCR) Per RECIST 1.1
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). 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; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients.
Time frame: From start of treatment until end of treatment, assessed up to 4.4 years
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | Japanese | 25.0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 23.1 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 41.7 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 66.7 percentage of participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | Japanese | 40.0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 24.0 percentage of participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 20.8 percentage of participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | Japanese | 16.7 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 20.0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 18.2 percentage of participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 20.0 percentage of participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 50.0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 60.0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 55.0 percentage of participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 50.0 percentage of participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 8.3 percentage of participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 28.6 percentage of participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 66.7 percentage of participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 41.7 percentage of participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 36.4 percentage of participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 50.0 percentage of participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 | ROW | 50.0 percentage of participants |
Secondary
Phase 1: Duration of Response (DOR) Per irRC
DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC.
Time frame: From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 4.4 years
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (irCR or irPR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Duration of Response (DOR) Per irRC | NA months |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Duration of Response (DOR) Per irRC | NA months |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Duration of Response (DOR) Per irRC | 12.2 months |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Duration of Response (DOR) Per irRC | NA months |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Duration of Response (DOR) Per irRC | NA months |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Duration of Response (DOR) Per irRC | 9.2 months |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Duration of Response (DOR) Per irRC | NA months |
Secondary
Phase 1: Duration of Response (DOR) Per RECIST 1.1
DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.
Time frame: From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (CR or PR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Duration of Response (DOR) Per RECIST 1.1 | NA months |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Duration of Response (DOR) Per RECIST 1.1 | NA months |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Duration of Response (DOR) Per RECIST 1.1 | 12.2 months |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Duration of Response (DOR) Per RECIST 1.1 | NA months |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Duration of Response (DOR) Per RECIST 1.1 | 18.4 months |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Duration of Response (DOR) Per RECIST 1.1 | 6.5 months |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Duration of Response (DOR) Per RECIST 1.1 | NA months |
Secondary
Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, Japanese patients | 32.6 ug/mL | Standard Deviation 1.2 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 21.8 ug/mL | Standard Deviation 6.52 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 34.7 ug/mL | Standard Deviation 13.2 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, Japanese patients | 23.1 ug/mL | Standard Deviation 2.58 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 124 ug/mL | Standard Deviation 30.5 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 72.4 ug/mL | Standard Deviation 14.1 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 272 ug/mL | — |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 117 ug/mL | Standard Deviation 26.7 |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 247 ug/mL | Standard Deviation 63.2 |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 306 ug/mL | — |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 607 ug/mL | Standard Deviation 108 |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 393 ug/mL | Standard Deviation 95.2 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, Japanese patients | 95.5 ug/mL | Standard Deviation 18.3 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 73.8 ug/mL | Standard Deviation 19.2 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, Japanese patients | 198 ug/mL | — |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 114 ug/mL | Standard Deviation 36.5 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 169 ug/mL | Standard Deviation 60.7 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, Japanese patients | 255 ug/mL | Standard Deviation 59.1 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 116 ug/mL | Standard Deviation 28.3 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, Japanese patients | 152 ug/mL | Standard Deviation 33.9 |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 77.9 ug/mL | Standard Deviation 11 |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 66.4 ug/mL | Standard Deviation 14.1 |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 117 ug/mL | Standard Deviation 26.2 |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 118 ug/mL | Standard Deviation 23.8 |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 222 ug/mL | Standard Deviation 0 |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 268 ug/mL | Standard Deviation 38.5 |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 250 ug/mL | Standard Deviation 187 |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 125 ug/mL | Standard Deviation 38.9 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 8.58 ug/mL | Standard Deviation 2.53 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 9.57 ug/mL | Standard Deviation 4.91 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 31.6 ug/mL | Standard Deviation 9.9 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 26.5 ug/mL | Standard Deviation 3.6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 24.1 ug/mL | Standard Deviation 6.58 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 35.2 ug/mL | Standard Deviation 7.29 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 25.1 ug/mL | Standard Deviation 6.81 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 33.8 ug/mL | Standard Deviation 7.75 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 156 ug/mL | Standard Deviation 70.4 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 87.9 ug/mL | Standard Deviation 24.7 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 73.1 ug/mL | Standard Deviation 14.7 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 88.7 ug/mL | Standard Deviation 25.3 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 114 ug/mL | Standard Deviation 19.8 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 122 ug/mL | Standard Deviation 36.4 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 215 ug/mL | Standard Deviation 43.9 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 274 ug/mL | Standard Deviation 57.1 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 27.2 ug/mL | Standard Deviation 5.51 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 32 ug/mL | Standard Deviation 17 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 121 ug/mL | Standard Deviation 8.96 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 174 ug/mL | Standard Deviation 11.3 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 354 ug/mL | Standard Deviation 118 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 276 ug/mL | Standard Deviation 66.5 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 303 ug/mL | Standard Deviation 82.3 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 513 ug/mL | Standard Deviation 72.8 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 33.3 ug/mL | Standard Deviation 14.5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 27.1 ug/mL | Standard Deviation 7.56 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 96 ug/mL | Standard Deviation 42.8 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 86.2 ug/mL | Standard Deviation 22.2 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, ROW patients | 147 ug/mL | Standard Deviation 43 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, ROW patients | 73.1 ug/mL | Standard Deviation 42.2 |
Secondary
Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 30.4 ug/mL | Standard Deviation 11.9 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 19.6 ug/mL | Standard Deviation 3.59 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 28.7 ug/mL | Standard Deviation 8.4 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 19.6 ug/mL | Standard Deviation 2.77 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 17.7 ug/mL | Standard Deviation 3.84 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 29.7 ug/mL | Standard Deviation 9.97 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 89.5 ug/mL | Standard Deviation 28.9 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 58.8 ug/mL | Standard Deviation 23.2 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 67.9 ug/mL | Standard Deviation 20.4 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 168 ug/mL | Standard Deviation 20.1 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 97.5 ug/mL | Standard Deviation 34.4 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 76.2 ug/mL | Standard Deviation 20 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 80 ug/mL | Standard Deviation 25.1 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 61.5 ug/mL | Standard Deviation 22.1 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 123 ug/mL | Standard Deviation 35.6 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 85.1 ug/mL | Standard Deviation 28 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 90.8 ug/mL | Standard Deviation 51.2 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 65 ug/mL | Standard Deviation 11.3 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 87.6 ug/mL | Standard Deviation 24.5 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 142 ug/mL | — |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 134 ug/mL | Standard Deviation 56.7 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 113 ug/mL | Standard Deviation 26.8 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 167 ug/mL | Standard Deviation 9.9 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 116 ug/mL | Standard Deviation 28.1 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 100 ug/mL | Standard Deviation 23.1 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 141 ug/mL | Standard Deviation 58.2 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 115 ug/mL | Standard Deviation 33.2 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 147 ug/mL | Standard Deviation 29.8 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, ROW patients | 97.9 ug/mL | Standard Deviation 17 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, ROW patients | 126 ug/mL | Standard Deviation 27.2 |
Secondary
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record.
Time frame: From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Japanese patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 4 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Japanese patients | 4 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 13 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 2 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 11 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 5 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 2 Participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 3 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 24 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 10 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Japanese patients | 2 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Japanese patients | 5 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Japanese patients | 6 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Japanese patients | 0 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 24 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 11 Participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 5 Participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 2 Participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 4 Participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 5 Participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 11 Participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 2 Participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 5 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 3 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 2 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 3 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 5 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 3 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 1 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 19 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 9 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 3 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 12 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 6 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 4 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 7 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 5 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 12 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 5 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 2 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 11 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 5 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 4 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, ROW patients | 4 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, ROW patients | 6 Participants |
Secondary
Phase 1: Number of Participants With Anti-LAG525 Antibodies
Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Time frame: Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable. Japanese patients were analyzed together with the rest of the world (ROW) patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 6 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 14 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 10 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 4 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 2 Participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 1 Participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 0 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 2 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 19 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 15 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 2 Participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 3 Participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 6 Participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 0 Participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 0 Participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 6 Participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 2 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 3 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 1 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 2 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 2 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 4 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 4 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 1 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 1 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 12 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 3 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 1 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 1 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 8 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 6 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 4 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 3 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 0 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 0 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 9 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 5 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 10 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 1 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline | 1 Participants |
Secondary
Phase 1: Number of Participants With Anti-PDR001 Antibodies
Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Time frame: Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 2 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 6 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 2 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 2 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 4 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 0 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 2 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 2 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 14 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 2 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 0 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 7 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 2 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 1 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 7 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 4 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 0 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 0 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 5 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 2 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 1 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 6 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 3 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 1 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 3 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline (i.e. ADA incidence) | 0 Participants |
Secondary
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable.
Time frame: From start of treatment until end of treatment, assessed up to 4.4 years.
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, Japanese patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, Japanese patients | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, Japanese patients | 0 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, Japanese patients | 2 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, Japanese patients | 2 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, Japanese patients | 0 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 0 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 4 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 4 Participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 1 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 0 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 6 Participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 6 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 2 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 1 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 1 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 3 Participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 3 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 0 Participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 4 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 3 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 0 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, ROW patients | 1 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, ROW patients | 0 Participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, ROW patients | 1 Participants |
Secondary
Phase 1: Overall Response Rate (ORR) Per irRC
TTumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (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 target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients.
Time frame: From start of treatment until end of treatment, assessed up to 4.4 years
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | Japanese | 0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | Japanese | 0 percentage of participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | Japanese | 0 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 20.0 percentage of participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per irRC | ROW | 0 percentage of participants |
Secondary
Phase 1: Overall Response Rate (ORR) Per RECIST 1.1
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 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 diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients.
Time frame: From start of treatment until end of treatment, assessed up to 4.4 years
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | Japanese | 0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | Japanese | 0 percentage of participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | Japanese | 0 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 20.0 percentage of participants |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 33.3 percentage of participants |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 16.7 percentage of participants |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 | ROW | 0 percentage of participants |
Secondary
Phase 1: Progression-free Survival (PFS) Per irRC
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported for ROW and Japanese patients.
Time frame: From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.9 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | Japanese | 1.8 months |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.9 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.6 months |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.9 months |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 3.4 months |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | Japanese | 1.8 months |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.8 months |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | Japanese | 1.7 months |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.9 months |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 2.8 months |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 2.6 months |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.8 months |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.5 months |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 3.8 months |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 4.2 months |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 2.6 months |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 8.4 months |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.8 months |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 2.8 months |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 7.5 months |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.6 months |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 2.0 months |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 3.1 months |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 3.2 months |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 1.5 months |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 2.0 months |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 3.8 months |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per irRC | ROW | 3.2 months |
Secondary
Phase 1: Progression-free Survival (PFS) Per RECIST 1.1
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported for ROW and Japanese patients.
Time frame: From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | Japanese | 1.8 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.8 months |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 2.3 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.6 months |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.9 months |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 7.9 months |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.7 months |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | Japanese | 1.8 months |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | Japanese | 1.7 months |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.8 months |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 2.8 months |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 2.1 months |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.8 months |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.5 months |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 3.8 months |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.9 months |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.8 months |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 8.4 months |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.8 months |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 2.8 months |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 6.5 months |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.4 months |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.8 months |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 3.1 months |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 2.3 months |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.5 months |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 1.9 months |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 3.8 months |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 | ROW | 3.2 months |
Secondary
Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). Japanese patients were not treated with PDR001 and therefore the RDI of this study drug is not applicable.
Time frame: From start of treatment until end of treatment, assessed up to 4.4 years.
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, Japanese patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 98.9 percentage | Standard Deviation 3.93 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 94.4 percentage | Standard Deviation 13.61 |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 98.2 percentage | Standard Deviation 4.47 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 99.0 percentage | Standard Deviation 5 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, Japanese patients | 98.0 percentage | Standard Deviation 4.47 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, Japanese patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 99.9 percentage | Standard Deviation 0.6 |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 97.3 percentage | Standard Deviation 6.72 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 97.4 percentage | Standard Deviation 6.27 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 99.7 percentage | Standard Deviation 0.84 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 97.6 percentage | Standard Deviation 5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 99.6 percentage | Standard Deviation 0.93 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 98.0 percentage | Standard Deviation 4.95 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 97.8 percentage | Standard Deviation 5.27 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 97.7 percentage | Standard Deviation 7.54 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, ROW patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, ROW patients | 100 percentage | Standard Deviation 0 |
Secondary
Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 11.2 days | Standard Deviation 2.62 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 7.65 days | Standard Deviation 1.94 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, Japanese patients | 5.49 days | Standard Deviation 2.38 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, Japanese patients | 13.7 days | Standard Deviation 10.2 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 14.4 days | Standard Deviation 5.82 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 11.1 days | Standard Deviation 4.12 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 9.99 days | Standard Deviation 2.37 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 5.94 days | — |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 12.2 days | — |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 12 days | Standard Deviation 4.5 |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 16.5 days | Standard Deviation 2.87 |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 12.8 days | Standard Deviation 8 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, Japanese patients | 19.4 days | — |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, Japanese patients | 9.42 days | Standard Deviation 2.27 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 10.3 days | Standard Deviation 3.5 |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 12.1 days | Standard Deviation 5.06 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, Japanese patients | 13.8 days | Standard Deviation 4.38 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 18 days | Standard Deviation 9.7 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 11.5 days | Standard Deviation 6.59 |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, Japanese patients | 28.1 days | Standard Deviation 18 |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 15 days | Standard Deviation 2.36 |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 13.5 days | Standard Deviation 4.07 |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 13.1 days | Standard Deviation 5.38 |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 20.6 days | Standard Deviation 8.51 |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 20.8 days | — |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 13.9 days | Standard Deviation 5.15 |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 23.4 days | Standard Deviation 14.6 |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 13.6 days | Standard Deviation 7.61 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 3.47 days | Standard Deviation 1.4 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 6.15 days | Standard Deviation 2.98 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 9.15 days | Standard Deviation 3.86 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 9.55 days | Standard Deviation 3.95 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 6.5 days | Standard Deviation 3.25 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 9.17 days | Standard Deviation 4.36 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 7.52 days | Standard Deviation 2.5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 13.1 days | Standard Deviation 0.736 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 14.7 days | — |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 9.5 days | Standard Deviation 2.78 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 14.3 days | Standard Deviation 7.02 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 11.5 days | Standard Deviation 3.7 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 11.3 days | Standard Deviation 4.94 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 14.5 days | Standard Deviation 1.24 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 10.2 days | Standard Deviation 3.68 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 13.8 days | Standard Deviation 4.45 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 11.1 days | Standard Deviation 10.9 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 7.49 days | Standard Deviation 4.42 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 18.3 days | Standard Deviation 3.58 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 15.7 days | Standard Deviation 4.23 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 17.9 days | Standard Deviation 7.88 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 15.1 days | Standard Deviation 5.44 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 14.4 days | Standard Deviation 3.28 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 26.3 days | Standard Deviation 11.9 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 7.32 days | Standard Deviation 4.94 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 5.26 days | Standard Deviation 2.43 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 10.8 days | Standard Deviation 1.76 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 9.12 days | Standard Deviation 2.07 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, ROW patients | 9.36 days | Standard Deviation 2.18 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, ROW patients | 15.1 days | Standard Deviation 4.54 |
Secondary
Phase 1: Terminal Elimination Half-life (T1/2) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 9.71 day | Standard Deviation 8.24 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 21.4 day | Standard Deviation 9.4 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 22.3 day | Standard Deviation 7.13 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 10.2 day | Standard Deviation 4.81 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 12.4 day | Standard Deviation 10.3 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 12.5 day | Standard Deviation 3.38 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 20.7 day | Standard Deviation 8.72 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 17.8 day | Standard Deviation 5.03 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 44.4 day | Standard Deviation 36.8 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 30.8 day | Standard Deviation 47 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 27.7 day | Standard Deviation 19.4 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 22.8 day | Standard Deviation 13.8 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 27.4 day | Standard Deviation 4.25 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 14.8 day | Standard Deviation 4.78 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 17.4 day | Standard Deviation 5.64 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 11.8 day | Standard Deviation 5 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 20.8 day | Standard Deviation 12.4 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 14 day | Standard Deviation 3.72 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 22.4 day | — |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 15.1 day | Standard Deviation 10.2 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 21.9 day | Standard Deviation 4.22 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 20.4 day | Standard Deviation 8.41 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 18.7 day | Standard Deviation 7.18 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 32.8 day | Standard Deviation 12.5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 20.4 day | Standard Deviation 10 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 16.7 day | Standard Deviation 10.2 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 14.6 day | Standard Deviation 5.48 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 16.1 day | Standard Deviation 5.64 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, ROW patients | 24.9 day | Standard Deviation 6.75 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, ROW patients | 17.3 day | Standard Deviation 2.76 |
Secondary
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Pharmacokinetic (PK) parameters were calculated based on LAG525 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, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, Japanese patients | 1.58 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, Japanese patients | 1.63 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.83 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.73 days |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 2.05 days |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.6 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.08 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.63 days |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.63 days |
| Phase 1: LAG525 10 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.55 days |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.67 days |
| Phase 1: LAG525 15 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.99 days |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.59 days |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.58 days |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, Japanese patients | 1.54 days |
| Phase 1: LAG525 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, Japanese patients | 1.57 days |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, Japanese patients | 1.54 days |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, Japanese patients | 1.6 days |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.57 days |
| Phase 1: LAG525 400 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.5 days |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.58 days |
| Phase 1: LAG525 3 mg/kg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 2.08 days |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 2.1 days |
| Phase 1: LAG525 5 mg/kg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.93 days |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 2.02 days |
| Phase 1: LAG525 10 mg/kg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.83 days |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.5 days |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.72 days |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.51 days |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.5 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.5 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.53 days |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.55 days |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.53 days |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.53 days |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.52 days |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.58 days |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.57 days |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.52 days |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.52 days |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.58 days |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.54 days |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.58 days |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.58 days |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.75 days |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.58 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.53 days |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.7 days |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.58 days |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, ROW patients | 1.58 days |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, ROW patients | 1.5 days |
Secondary
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 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. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.5 days |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.58 days |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.55 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.55 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.63 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.72 days |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.51 days |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.75 days |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.5 days |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.53 days |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.5 days |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.75 days |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.53 days |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.58 days |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.58 days |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.63 days |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.8 days |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.53 days |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.66 days |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.87 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.5 days |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.55 days |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.55 days |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.58 days |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, ROW patients | 1.58 days |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, ROW patients | 1.56 days |
Secondary
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, NSCLC patients | 1260 day*ug/mL | Standard Deviation 509 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, melanoma patients | 1030 day*ug/mL | Standard Deviation 404 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, mesothelioma patients | 1400 day*ug/mL | Standard Deviation 732 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, RCC patients | 1420 day*ug/mL | Standard Deviation 678 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, TNBC patients | 1180 day*ug/mL | Standard Deviation 379 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, RCC patients | 979 day*ug/mL | Standard Deviation 366 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, mesothelioma patients | 963 day*ug/mL | Standard Deviation 329 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, melanoma patients | 1860 day*ug/mL | Standard Deviation 507 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, TNBC patients | 1710 day*ug/mL | Standard Deviation 1090 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, NSCLC patients | 1500 day*ug/mL | Standard Deviation 688 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, TNBC patients | 2010 day*ug/mL | Standard Deviation 807 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, TNBC patients | 2800 day*ug/mL | Standard Deviation 1210 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, TNBC patients | 1530 day*ug/mL | Standard Deviation 578 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, NSCLC patients | 955 day*ug/mL | Standard Deviation 272 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, NSCLC patients | 1260 day*ug/mL | Standard Deviation 554 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, melanoma patients | 953 day*ug/mL | Standard Deviation 340 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, melanoma patients | 1680 day*ug/mL | Standard Deviation 754 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, RCC patients | 1280 day*ug/mL | Standard Deviation 809 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, mesothelioma patients | 1070 day*ug/mL | Standard Deviation 350 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 3, mesothelioma patients | 1380 day*ug/mL | Standard Deviation 729 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, TNBC patients | 1150 day*ug/mL | Standard Deviation 234 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | Cycle 1, RCC patients | 886 day*ug/mL | Standard Deviation 429 |
Secondary
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, TNBC patients | 808 day*ug/mL | Standard Deviation 331 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, NSCLC patients | 853 day*ug/mL | Standard Deviation 347 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, NSCLC patients | 1020 day*ug/mL | Standard Deviation 500 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, melanoma patients | 663 day*ug/mL | Standard Deviation 291 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, melanoma patients | 1390 day*ug/mL | Standard Deviation 406 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, RCC patients | 739 day*ug/mL | Standard Deviation 227 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, RCC patients | 879 day*ug/mL | Standard Deviation 547 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, mesothelioma patients | 633 day*ug/mL | Standard Deviation 263 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, mesothelioma patients | 1110 day*ug/mL | Standard Deviation 500 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, TNBC patients | 1370 day*ug/mL | Standard Deviation 570 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, TNBC patients | 2150 day*ug/mL | Standard Deviation 1180 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, TNBC patients | 1110 day*ug/mL | Standard Deviation 621 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, RCC patients | 1060 day*ug/mL | Standard Deviation 464 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, TNBC patients | 1360 day*ug/mL | Standard Deviation 351 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, NSCLC patients | 629 day*ug/mL | Standard Deviation 197 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, mesothelioma patients | 747 day*ug/mL | Standard Deviation 388 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, RCC patients | 617 day*ug/mL | Standard Deviation 347 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, melanoma patients | 633 day*ug/mL | Standard Deviation 310 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, mesothelioma patients | 1110 day*ug/mL | Standard Deviation 606 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, melanoma patients | 1070 day*ug/mL | Standard Deviation 537 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 3, NSCLC patients | 881 day*ug/mL | Standard Deviation 443 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 | Cycle 1, TNBC patients | 766 day*ug/mL | Standard Deviation 277 |
Secondary
Phase 2: Disease Control Rate (DCR) Per irRC
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). 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 target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type.
Time frame: From start of treatment until end of treatment, assessed up to 2.6 years
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Mesothelioma | 65.9 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Renal cell cancer (RCC) | 68.4 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Triple negative breast cancer (TNBC) | 33.3 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Non-small cell lung cancer (NSCLC) | 60.0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Melanoma | 55.0 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Triple negative breast cancer (TNBC) | 28.6 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Triple negative breast cancer (TNBC) | 21.4 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Non-small cell lung cancer (NSCLC) | 50.0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Melanoma | 40.9 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Renal cell cancer (RCC) | 42.1 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per irRC | Mesothelioma | 56.3 percentage of participants |
Secondary
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). 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; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type.
Time frame: From start of treatment until end of treatment, assessed up to 2.6 years
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Mesothelioma | 65.9 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Non-small cell lung cancer (NSCLC) | 50.0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | 33.3 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Renal cell cancer (RCC) | 63.2 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Melanoma | 45.0 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | 23.8 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | 21.4 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Melanoma | 40.9 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Renal cell cancer (RCC) | 42.1 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Mesothelioma | 56.3 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 | Non-small cell lung cancer (NSCLC) | 50.0 percentage of participants |
Secondary
Phase 2: Duration of Response (DOR) Per irRC
DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. DOR is reported by tumor type.
Time frame: From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (irCR or irPR).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per irRC | Non-small cell lung cancer (NSCLC) | NA months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per irRC | Melanoma | 17.5 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per irRC | Triple negative breast cancer (TNBC) | NA months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per irRC | Renal cell cancer (RCC) | NA months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per irRC | Mesothelioma | NA months |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per irRC | Triple negative breast cancer (TNBC) | NA months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per irRC | Renal cell cancer (RCC) | NA months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per irRC | Melanoma | NA months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per irRC | Mesothelioma | NA months |
Secondary
Phase 2: Duration of Response (DOR) Per RECIST 1.1
DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. DOR is reported by tumor type.
Time frame: From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 2.6 years
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (CR or PR).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per RECIST 1.1 | Mesothelioma | NA months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per RECIST 1.1 | Melanoma | 11.0 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per RECIST 1.1 | Non-small cell lung cancer (NSCLC) | 5.0 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per RECIST 1.1 | Renal cell cancer (RCC) | NA months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | NA months |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | NA months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per RECIST 1.1 | Mesothelioma | NA months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per RECIST 1.1 | Renal cell cancer (RCC) | NA months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Duration of Response (DOR) Per RECIST 1.1 | Melanoma | NA months |
Secondary
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, mesothelioma patients | 141 ug/mL | Standard Deviation 39.7 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, TNBC patients | 144 ug/mL | Standard Deviation 32.4 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, TNBC patients | 179 ug/mL | Standard Deviation 65.2 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, NSCLC patients | 154 ug/mL | Standard Deviation 43.5 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, NSCLC patients | 169 ug/mL | Standard Deviation 51.9 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, melanoma patients | 115 ug/mL | Standard Deviation 29.9 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, melanoma patients | 171 ug/mL | Standard Deviation 32 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, RCC patients | 118 ug/mL | Standard Deviation 34.7 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, RCC patients | 158 ug/mL | Standard Deviation 45.4 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, mesothelioma patients | 116 ug/mL | Standard Deviation 31 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, TNBC patients | 207 ug/mL | Standard Deviation 53.1 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, TNBC patients | 190 ug/mL | Standard Deviation 55 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, melanoma patients | 102 ug/mL | Standard Deviation 36.7 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, RCC patients | 153 ug/mL | Standard Deviation 43.5 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, TNBC patients | 132 ug/mL | Standard Deviation 26.7 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, melanoma patients | 163 ug/mL | Standard Deviation 52.8 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, TNBC patients | 157 ug/mL | Standard Deviation 33.2 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, mesothelioma patients | 138 ug/mL | Standard Deviation 33.1 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, NSCLC patients | 106 ug/mL | Standard Deviation 26.8 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 3, NSCLC patients | 137 ug/mL | Standard Deviation 30.8 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, RCC patients | 111 ug/mL | Standard Deviation 28.3 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | Cycle 1, mesothelioma patients | 119 ug/mL | Standard Deviation 37.6 |
Secondary
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, mesothelioma patients | 96.5 ug/mL | Standard Deviation 31.5 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, melanoma patients | 75.7 ug/mL | Standard Deviation 25.2 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, RCC patients | 104 ug/mL | Standard Deviation 23.8 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, TNBC patients | 91.5 ug/mL | Standard Deviation 25.1 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, mesothelioma patients | 70.5 ug/mL | Standard Deviation 21.4 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, melanoma patients | 117 ug/mL | Standard Deviation 29.8 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, RCC patients | 81 ug/mL | Standard Deviation 21.3 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, NSCLC patients | 118 ug/mL | Standard Deviation 36.5 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, TNBC patients | 124 ug/mL | Standard Deviation 36.5 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, NSCLC patients | 102 ug/mL | Standard Deviation 33 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, TNBC patients | 117 ug/mL | Standard Deviation 36.7 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, TNBC patients | 134 ug/mL | Standard Deviation 54 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, TNBC patients | 123 ug/mL | Standard Deviation 18.5 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, NSCLC patients | 68.9 ug/mL | Standard Deviation 17.3 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, melanoma patients | 71.3 ug/mL | Standard Deviation 26.2 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, mesothelioma patients | 113 ug/mL | Standard Deviation 36.8 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, NSCLC patients | 100 ug/mL | Standard Deviation 24.2 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, melanoma patients | 105 ug/mL | Standard Deviation 43.3 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, RCC patients | 67 ug/mL | Standard Deviation 25.8 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3, RCC patients | 103 ug/mL | Standard Deviation 36.1 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, mesothelioma patients | 82.7 ug/mL | Standard Deviation 39 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1, TNBC patients | 89.8 ug/mL | Standard Deviation 14.8 |
Secondary
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants with AEs and SAEs is reported for each tumor type.
Time frame: From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Melanoma | 8 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Melanoma | 19 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Mesothelioma | 15 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Renal cell cancer (RCC) | 19 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Triple negative breast cancer (TNBC) | 21 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Renal cell cancer (RCC) | 14 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Mesothelioma | 41 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Non-small cell lung cancer (NSCLC) | 13 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Triple negative breast cancer (TNBC) | 9 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Non-small cell lung cancer (NSCLC) | 19 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Triple negative breast cancer (TNBC) | 21 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Triple negative breast cancer (TNBC) | 10 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Triple negative breast cancer (TNBC) | 4 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Non-small cell lung cancer (NSCLC) | 22 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Non-small cell lung cancer (NSCLC) | 7 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Melanoma | 22 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Melanoma | 8 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Renal cell cancer (RCC) | 19 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Renal cell cancer (RCC) | 5 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Mesothelioma | 16 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs, Mesothelioma | 4 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs, Triple negative breast cancer (TNBC) | 14 Participants |
Secondary
Phase 2: Number of Participants With Anti-LAG525 Antibodies
Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Time frame: Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, melanoma patients | 1 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, NSCLC patients | 19 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, TNBC patients | 2 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, mesothelioma patients | 35 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, NSCLC patients | 4 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, mesothelioma patients | 3 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, melanoma patients | 15 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, RCC patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, TNBC patients | 15 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, RCC patients | 17 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, TNBC patients | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, TNBC patients | 15 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, TNBC patients | 11 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, RCC patients | 13 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, TNBC patients | 1 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, NSCLC patients | 19 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, NSCLC patients | 2 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, melanoma patients | 19 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, melanoma patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, RCC patients | 1 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-negative at baseline, mesothelioma patients | 13 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-LAG525 Antibodies | ADA-positive at post-baseline, mesothelioma patients | 1 Participants |
Secondary
Phase 2: Number of Participants With Anti-PDR001 Antibodies
Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Time frame: Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, melanoma patients | 5 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, melanoma patients | 16 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, mesothelioma patients | 6 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, RCC patients | 17 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, TNBC patients | 17 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, RCC patients | 2 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, mesothelioma patients | 32 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, NSCLC patients | 6 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, TNBC patients | 5 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, NSCLC patients | 18 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, TNBC patients | 13 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, TNBC patients | 1 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, TNBC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, NSCLC patients | 21 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, NSCLC patients | 4 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, melanoma patients | 19 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, melanoma patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, RCC patients | 12 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, RCC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, mesothelioma patients | 11 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at post-baseline, mesothelioma patients | 2 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline, TNBC patients | 9 Participants |
Secondary
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type.
Time frame: From start of treatment until end of treatment, assessed up to 2.6 years.
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, melanoma patients | 4 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, melanoma patients | 4 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, melanoma patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, TNBC patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, TNBC patients | 3 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, mesothelioma patients | 8 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, TNBC patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, mesothelioma patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, mesothelioma patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, TNBC patients | 3 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, melanoma patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, mesothelioma patients | 8 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, NSCLC patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, RCC patients | 5 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, NSCLC patients | 3 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, RCC patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, NSCLC patients | 0 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, RCC patients | 5 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, NSCLC patients | 3 Participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, RCC patients | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, TNBC patients | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, TNBC patients | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, TNBC patients | 0 Participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, TNBC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, melanoma patients | 4 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, melanoma patients | 4 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, NSCLC patients | 3 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, RCC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, NSCLC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, RCC patients | 1 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, NSCLC patients | 3 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, RCC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, NSCLC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, RCC patients | 1 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, TNBC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, mesothelioma patients | 5 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, TNBC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, mesothelioma patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose interruption, TNBC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose interruption, mesothelioma patients | 5 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, mesothelioma patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, melanoma patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | LAG525 dose reduction, TNBC patients | 0 Participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | PDR001 dose reduction, melanoma patients | 0 Participants |
Secondary
Phase 2: Overall Response Rate (ORR) Per irRC
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (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 target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type.
Time frame: From start of treatment until end of treatment, assessed up to 2.6 years
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Melanoma | 15.0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Mesothelioma | 19.5 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Triple negative breast cancer (TNBC) | 14.3 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Non-small cell lung cancer (NSCLC) | 15.0 percentage of participants |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Renal cell cancer (RCC) | 26.3 percentage of participants |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Triple negative breast cancer (TNBC) | 4.8 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Triple negative breast cancer (TNBC) | 0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Non-small cell lung cancer (NSCLC) | 0 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Melanoma | 9.1 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Renal cell cancer (RCC) | 5.3 percentage of participants |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Overall Response Rate (ORR) Per irRC | Mesothelioma | 6.3 percentage of participants |
Secondary
Phase 2: Progression-free Survival (PFS) Per irRC
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported by tumor type.
Time frame: From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Triple negative breast cancer (TNBC) | 1.9 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Non-small cell lung cancer (NSCLC) | 4.2 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Melanoma | 5.4 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Renal cell cancer (RCC) | 5.8 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Mesothelioma | 5.6 months |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Triple negative breast cancer (TNBC) | 1.9 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Renal cell cancer (RCC) | 3.0 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Melanoma | 1.9 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Triple negative breast cancer (TNBC) | 1.7 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Mesothelioma | 3.4 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per irRC | Non-small cell lung cancer (NSCLC) | 3.5 months |
Secondary
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported by tumor type.
Time frame: From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Mesothelioma | 5.5 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Renal cell cancer (RCC) | 4.4 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | 1.9 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Non-small cell lung cancer (NSCLC) | 3.9 months |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Melanoma | 2.2 months |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | 1.8 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Triple negative breast cancer (TNBC) | 1.7 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Non-small cell lung cancer (NSCLC) | 3.5 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Melanoma | 1.9 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Renal cell cancer (RCC) | 3.0 months |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 | Mesothelioma | 3.4 months |
Secondary
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). The RDI of both study drugs is reported for each tumor type.
Time frame: From start of treatment until end of treatment, assessed up to 2.6 years.
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, TNBC patients | 96.5 percentage | Standard Deviation 11.08 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, TNBC patients | 98.4 percentage | Standard Deviation 7.21 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, NSCLC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, NSCLC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, melanoma patients | 99.4 percentage | Standard Deviation 2.8 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, melanoma patients | 99.4 percentage | Standard Deviation 2.8 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, RCC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, RCC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, mesothelioma patients | 99.3 percentage | Standard Deviation 4.26 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, mesothelioma patients | 99.3 percentage | Standard Deviation 4.26 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, TNBC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, TNBC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, melanoma patients | 99.7 percentage | Standard Deviation 1.47 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, TNBC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, mesothelioma patients | 99.4 percentage | Standard Deviation 1.99 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, TNBC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, RCC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, NSCLC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, NSCLC patients | 99.8 percentage | Standard Deviation 0.71 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | LAG525, melanoma patients | 99.7 percentage | Standard Deviation 1.47 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, RCC patients | 100 percentage | Standard Deviation 0 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | PDR001, mesothelioma patients | 99.4 percentage | Standard Deviation 1.99 |
Secondary
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and had a valid measure of the endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, NSCLC patients | 11.6 days | Standard Deviation 6.11 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, NSCLC patients | 16.3 days | Standard Deviation 9.17 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, melanoma patients | 15.6 days | Standard Deviation 5.18 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, melanoma patients | 20.1 days | Standard Deviation 5.24 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, RCC patients | 14.2 days | Standard Deviation 3.61 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, RCC patients | 14.1 days | Standard Deviation 3.71 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, mesothelioma patients | 13 days | Standard Deviation 5.13 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, mesothelioma patients | 18.4 days | Standard Deviation 7.16 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, TNBC patients | 22.5 days | Standard Deviation 18.9 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, TNBC patients | 18.7 days | Standard Deviation 9.14 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, TNBC patients | 14.6 days | Standard Deviation 3.82 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, RCC patients | 23.1 days | Standard Deviation 6.33 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, NSCLC patients | 13.3 days | Standard Deviation 4.62 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, NSCLC patients | 15.9 days | Standard Deviation 7.88 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, mesothelioma patients | 13.7 days | Standard Deviation 5.27 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, melanoma patients | 15.5 days | Standard Deviation 5.92 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, TNBC patients | 14.4 days | Standard Deviation 5.01 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, melanoma patients | 19.2 days | Standard Deviation 9.26 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, mesothelioma patients | 18.7 days | Standard Deviation 5.47 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 3, TNBC patients | 19 days | Standard Deviation 4.78 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | Cycle 1, RCC patients | 14.1 days | Standard Deviation 5.39 |
Secondary
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Time frame: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 2 who received at least one full or partial dose of PDR001 and had a valid measure of the endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, melanoma patients | 24.2 days | Standard Deviation 6.17 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, melanoma patients | 29.1 days | Standard Deviation 31.6 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, mesothelioma patients | 25.2 days | Standard Deviation 14.5 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, RCC patients | 17.8 days | Standard Deviation 4.77 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, TNBC patients | 18.8 days | Standard Deviation 8.33 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, RCC patients | 18.4 days | Standard Deviation 5.02 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, mesothelioma patients | 19.1 days | Standard Deviation 7.98 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, NSCLC patients | 16.8 days | Standard Deviation 7.88 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, TNBC patients | 23.9 days | Standard Deviation 17.1 |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, NSCLC patients | 17.2 days | Standard Deviation 10 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, TNBC patients | 21.3 days | Standard Deviation 7.43 |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, TNBC patients | 22.2 days | Standard Deviation 0.591 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, TNBC patients | 23.8 days | Standard Deviation 5.64 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, NSCLC patients | 15.8 days | Standard Deviation 5.65 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, NSCLC patients | 24.5 days | Standard Deviation 8.47 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, melanoma patients | 20 days | Standard Deviation 5.66 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, melanoma patients | 25.6 days | Standard Deviation 15.7 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, RCC patients | 18.4 days | Standard Deviation 7.3 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, RCC patients | 24.2 days | Standard Deviation 5.05 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, mesothelioma patients | 25.6 days | Standard Deviation 7.49 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 3, mesothelioma patients | 17.3 days | Standard Deviation 8.11 |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 | Cycle 1, TNBC patients | 19.9 days | Standard Deviation 6.24 |
Secondary
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Pharmacokinetic (PK) parameters were calculated based on LAG525 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, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, NSCLC patients | 1.53 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, NSCLC patients | 1.55 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, mesothelioma patients | 1.53 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, melanoma patients | 1.51 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, TNBC patients | 1.53 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, RCC patients | 1.58 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, RCC patients | 1.51 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, melanoma patients | 1.53 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, TNBC patients | 1.63 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, mesothelioma patients | 1.5 days |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, TNBC patients | 1.53 days |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, TNBC patients | 1.78 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, TNBC patients | 1.6 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, melanoma patients | 1.53 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, RCC patients | 1.53 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, RCC patients | 1.53 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, mesothelioma patients | 1.55 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, mesothelioma patients | 1.52 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, NSCLC patients | 1.55 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 3, NSCLC patients | 1.58 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, TNBC patients | 1.58 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | Cycle 1, melanoma patients | 1.53 days |
Secondary
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 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, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Population: All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, TNBC patients | 1.58 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, melanoma patients | 1.57 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, RCC patients | 1.58 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, RCC patients | 1.53 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, melanoma patients | 1.55 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, mesothelioma patients | 1.55 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, NSCLC patients | 1.57 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, mesothelioma patients | 1.52 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, TNBC patients | 1.6 days |
| Phase 1: LAG525 1 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, NSCLC patients | 1.57 days |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, TNBC patients | 1.57 days |
| Phase 1: LAG525 3 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, TNBC patients | 1.75 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, TNBC patients | 1.65 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, NSCLC patients | 1.57 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, NSCLC patients | 1.58 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, mesothelioma patients | 1.5 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, TNBC patients | 1.53 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, melanoma patients | 1.53 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, melanoma patients | 1.53 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, RCC patients | 1.57 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3, RCC patients | 1.58 days |
| Phase 1: LAG525 5 mg/kg Q2W | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1, mesothelioma patients | 1.54 days |