Advanced Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Hepatocellular Carcinoma, Melanoma, Metastatic Cancer, Non-small Cell Lung Cancer, Pancreatic Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Cancer
Conditions
Brief summary
A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of alomfilimab as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.
Interventions
DRUGAlomfilimab
A human anti-ICOS monoclonal antibody
DRUGAtezolizumab
An anti-PD-L1 monoclonal antibody
Sponsors
Sanofi
Kymab Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years (≥20 years in Taiwan) * Histologically documented advanced/metastatic malignancies * Phase 1 and Phase 2 participants with advanced/metastatic malignancies who have measurable disease (non-measurable disease is allowed only in Phase 1) as determined by RECIST 1.1 will be eligible if, according to the National Comprehensive Cancer Network (NCCN) guidelines, there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options. Additionally, the following specific tumor indications will be enrolled: 1. Phase 1: Participants with advanced/metastatic malignancies, and preferred indications (non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), melanoma, cervical, esophageal, gastric, renal, pancreatic, and triple negative breast cancer) 2. Phase 2 Alomfilimab single agent: Participants with advanced/metastatic malignancies in indications in which signs of anti-tumor activity (Complete Response (CR), Partial Response (PR) or durable stable disease (SD) with tumor shrinkage that does not qualify for PR) were seen during the dose escalation of Alomfilimab as single agent 3. Phase 2 Alomfilimab in combination with atezolizumab: Participants with advanced/metastatic malignancies in the selected indications below, and/or indications which have shown promising activity in Phase 1: * NSCLC (anti-PD-(L)1 therapy naïve and pre-treated between 1 and 2 prior lines of systemic therapy for advanced disease) * Gastric (anti-PD-(L)1 therapy naïve and pre-treated) * Recurrent and/or metastatic HNSCC (anti-PD-(L)1 therapy naïve and pre-treated between 1 and 2 prior lines of systemic therapy for advanced disease) * Esophageal (anti-PD-(L)1 therapy naïve and pre-treated) * Cervical (anti-PD-(L)1 therapy naïve and pre-treated) * Indications, in which signs of anti-tumor activity has been observed in Phase 1 with Alomfilimab in combination with atezolizumab * Prior therapy with anti-PD-(L)1 inhibitors is allowed provided any toxicity attributed to prior anti-PD-(L)1-directed therapy did not lead to discontinuation of therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Life expectancy longer than 12 weeks * Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Participants must be willing to undergo a new tumor biopsy at screening, and during therapy on the study
Exclusion criteria
* 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 of first dose of study treatment * History of severe hypersensitivity reactions to other monoclonal antibodies and/or their excipients * Known presence of neutralizing anti-atezolizumab antibodies (for patients previously treated with atezolizumab) * Having out of range laboratory values: creatinine, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), absolute neutrophil count (ANC), platelet count, hemoglobin * Impaired cardiac function or clinically significant cardiac disease, including any of the following: 1. Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association \[NYHA\] Grade ≥2), uncontrolled hypertension or clinically significant arrhythmia 2. QTcF \>470 msec on screening (electrocardiogram) ECG using Fridericia's formula (QTcF) or congenital long QT syndrome 3. Acute myocardial infarction or unstable angina pectoris * Known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection * Malignant disease, other than that being treated in this study * Any medical condition that would, in the Investigator's judgment, prevent participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results * Active autoimmune disease or a documented history of autoimmune disease * Participants previously exposed to anti-PD-(L)1 treatment who are not adequately treated for skin rash or had no replacement therapy for endocrinopathies should be excluded * Participants with a history of drug-induced pneumonitis or current pneumonitis * Systemic steroid therapy or any immunosuppressive therapy. Topical, inhaled, nasal, and ophthalmic steroids are not prohibited * Use of live attenuated vaccines against infectious diseases within 4 weeks of the first dose of study treatment. SARS-CoV-2 vaccines authorized for use by the competent local regulatory health authorities for active immunization to prevent COVID 19 are allowed (unless the vaccine is live or live attenuated) and must be given in accordance with the prevailing immunization guidelines. * Anti-CTLA4, anti-PD-(L)1 treatment within 4 weeks of the first dose of study treatment * Pre-treatment with anti-CTLA4 antibodies in combination with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway * Presence of Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) ≥Grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if CTCAE v5 ≥Grade 3) due to prior cancer therapy * Radiotherapy within 2 weeks of the first dose of study treatment, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass. To allow evaluation for response to treatment, participants enrolled in the Phase 2 part must have remaining measurable disease that has not been irradiated * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Number of Participants Experiencing Dose Changes | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks | Dose changes were defined as infusion interruption and dose reduction. |
| Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks | An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An serious AE (SAE) was any AE that: * resulted in death; * was life-threatening; * resulted in inpatient hospitalization or prolongation of existing hospitalization; * resulted in a persistent or significant disability/incapacity; * resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs; * constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment. |
| Phase 1: Absolute Dose Intensity | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks | Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks). |
| Phase 1: Relative Dose Intensity | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks | Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration. |
| Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | From first dose of study treatment (Day 1) up to 21 days | A DLT was defined as a clinically relevant AE or abnormal laboratory value of Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) ≥ Grade 3 assessed as unrelated to disease, PD, inter-current illness or concomitant medications, which occurs within the first cycle (21 days) of treatment with alomfilimab as single agent or in combination with atezolizumab during the dose escalation part of the study. |
| Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 162 weeks | ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% confidence interval (CI) was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate at 12 and 24 Months | Months 12 and 24 | Overall Survival rate was defined as the proportion of participants that had known survival status. Overall survival rate was obtained via Kaplan Meier estimation using the complimentary log-log transformation method. |
| Phase 2: Number of Participants Experiencing TEAEs | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An SAE was any AE that: * resulted in death; * was life-threatening; * resulted in inpatient hospitalization or prolongation of existing hospitalization; * resulted in a persistent or significant disability/incapacity; * resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs; * constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment. |
| Phase 2: Number of Participants Experiencing Dose Changes | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks | Dose changes were defined as infusion interruption and dose reduction. |
| Phase 2: Absolute Dose Intensity | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks | Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks). |
| Best Overall Response (BOR) Per RECIST 1.1 | From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively | BOR for each participant was defined as the best confirmed response per RECIST 1.1 among all responses recorded from start of treatment until PD, initiation of new anti-cancer therapy, death, or analysis cut-off date, whichever comes first, with responses of: CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. Not evaluable (NE). |
| Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length) | The serum pharmacokinetics (PK) of alomfilimab were characterized using non-compartmental analysis (NCA). Nominal times of sample collections were used for the NCA. All below limit of quantification (BLQ) values were set to 0 units. |
| Phase 1: Half-life (t1/2) of Alomfilimab | Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length) | The serum PK of alomfilimab were characterized using NCA. Nominal times of sample collections were used for the NCA. All BLQ values were set to 0 units. |
| Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | Phase 1: pre-infusion at all cycles (up to 69 cycles) + 90 days SFUP; Phase 2: pre-infusion at all cycles (up to 28 cycles) + 90 day SFUP (21 day cycle length) | Detection of ADA was assessed from blood samples taken during the study using validated bioanalytical methods. The number of participants who developed detectable anti-alomfilimab or anti-atezolizumab antibodies during any cycle or the safety follow-up period (SFUP) was calculated. |
| Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | Baseline and Cycle 2 Day 8 (21 day cycle length) | Biological samples (e.g., archived and fresh tumor samples or blood samples) were collected for analysis of responsive biomarkers. The summary of change in the following markers were calculated: * FOXP3-ICOS double-positive cells per mm\^2 in the Tumor * CD8-positive cells per mm\^2 in the tumor * CD8-positive cells per mm\^2 in the invasive margin. |
| Phase 2: Relative Dose Intensity | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks | Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration. |
| Progression-free Survival (PFS) Per RECIST 1.1 | From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively | PFS was calculated as (first documented PD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. |
| Duration of Response Per RECIST 1.1 | From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively | Duration of response was calculated as (date of the first documentation of PD or to death due to any cause in the absence of PD - date of the first documentation of unconfirmed objective response \[CR or PR\] + 1\]/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants with no disease assessment (or only had assessments with response = NE) after first study treatment or have baseline or post-baseline assessments where the RECIST criteria could not be applied had their duration of response time censored. Duration of response was obtained via Kaplan Meier estimation. |
| ORR Per iRECIST | From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively | RECIST 1.1 has been modified to take into consideration the unique response kinetics which have been observed with immunotherapy in some patients where responses to immune therapies may occur after progression has been assessed. ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete immune-response (iCR) or partial immune-response (iPR) according to iRECIST as the best response. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). iCR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). iPR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. |
| PFS Per iRECIST | From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively | PFS was calculated as (first documented iPD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. iPD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. |
| Phase 1: ORR Per RECIST 1.1 | From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 weeks | ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of CR or PR according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. |
Countries
Hungary, Italy, Poland, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 22 centers in 6 countries. A total of 222 participants, of which 0 were screen failures. Participants were enrolled from 28 January 2019 to 04 August 2023.
Participants by arm
| Arm | Count |
|---|---|
| Alomfilimab 0.8 mg Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 4 |
| Alomfilimab 2.4 mg Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 5 |
| Alomfilimab 8 mg Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 9 |
| Alomfilimab 24 mg Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 8 |
| Alomfilimab 80 mg Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 7 |
| Alomfilimab 240 mg Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 5 |
| Alomfilimab 0.8 mg + Atezolizumab Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 5 |
| Alomfilimab 2.4 mg + Atezolizumab Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 43 |
| Alomfilimab 8 mg + Atezolizumab Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 36 |
| Alomfilimab 24 mg + Atezolizumab Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 9 |
| Alomfilimab 80 mg + Atezolizumab Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 9 |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 15 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 14 |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 7 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 14 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 5 |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 5 |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 2 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 1 |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 1 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 6 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 3 |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. | 9 |
| Total | 222 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 2 | 4 | 5 | 6 | 5 | 4 | 5 | 24 | 22 | 6 | 3 | 10 | 10 | 5 | 7 | 2 | 2 | 1 | 1 | 1 | 1 | 2 | 3 |
| Overall Study | Lost to Follow Up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | 0 | 2 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Miscellaneous | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | PD | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 2 | 0 | 0 | 0 | 1 | 0 | 3 |
| Overall Study | Withdrawal of Consent | 2 | 0 | 3 | 0 | 1 | 1 | 0 | 10 | 10 | 3 | 4 | 4 | 4 | 0 | 3 | 0 | 1 | 1 | 0 | 0 | 3 | 0 | 1 |
Baseline characteristics
| Characteristic | Alomfilimab 2.4 mg | Alomfilimab 8 mg | Alomfilimab 24 mg | Alomfilimab 80 mg | Alomfilimab 240 mg | Alomfilimab 0.8 mg + Atezolizumab | Alomfilimab 2.4 mg + Atezolizumab | Alomfilimab 8 mg + Atezolizumab | Alomfilimab 24 mg + Atezolizumab | Alomfilimab 80 mg + Atezolizumab | Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Alomfilimab 0.8 mg | Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized >= 18 - 64 years | 2 Participants | 6 Participants | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 27 Participants | 27 Participants | 5 Participants | 5 Participants | 8 Participants | 5 Participants | 2 Participants | 6 Participants | 10 Participants | 3 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 133 Participants |
| Age, Customized >= 65 to 84 years | 3 Participants | 3 Participants | 6 Participants | 3 Participants | 1 Participants | 3 Participants | 16 Participants | 9 Participants | 4 Participants | 4 Participants | 7 Participants | 9 Participants | 2 Participants | 1 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 6 Participants | 88 Participants |
| Age, Customized >= 85 years | 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 | 0 Participants | 1 Participants |
| Ethnicity Not Collected | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 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 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 9 Participants | 6 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 28 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Missing | 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 | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other 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 |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 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 | 4 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 8 Participants | 8 Participants | 5 Participants | 5 Participants | 5 Participants | 30 Participants | 28 Participants | 6 Participants | 6 Participants | 14 Participants | 14 Participants | 4 Participants | 7 Participants | 13 Participants | 4 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 8 Participants | 181 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 6 Participants | 3 Participants | 3 Participants | 3 Participants | 20 Participants | 20 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 3 Participants | 7 Participants | 14 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 6 Participants | 1 Participants | 4 Participants | 118 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 23 Participants | 16 Participants | 4 Participants | 5 Participants | 9 Participants | 8 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 5 Participants | 104 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 4 | 4 / 5 | 5 / 9 | 7 / 8 | 5 / 7 | 4 / 5 | 5 / 5 | 24 / 43 | 22 / 36 | 6 / 9 | 3 / 9 | 10 / 15 | 10 / 14 | 5 / 7 | 7 / 14 | 3 / 5 | 2 / 5 | 1 / 2 | 1 / 1 | 1 / 1 | 1 / 6 | 2 / 3 | 4 / 9 |
| other Total, other adverse events | 4 / 4 | 4 / 5 | 7 / 10 | 7 / 8 | 7 / 7 | 5 / 5 | 4 / 5 | 39 / 43 | 34 / 35 | 9 / 9 | 9 / 9 | 15 / 15 | 13 / 14 | 7 / 7 | 14 / 14 | 5 / 5 | 5 / 5 | 2 / 2 | 1 / 1 | 1 / 1 | 6 / 6 | 2 / 3 | 8 / 8 |
| serious Total, serious adverse events | 1 / 4 | 1 / 5 | 3 / 10 | 2 / 8 | 3 / 7 | 2 / 5 | 2 / 5 | 17 / 43 | 11 / 35 | 4 / 9 | 3 / 9 | 6 / 15 | 2 / 14 | 1 / 7 | 2 / 14 | 1 / 5 | 1 / 5 | 1 / 2 | 0 / 1 | 0 / 1 | 2 / 6 | 1 / 3 | 4 / 8 |
Outcome results
Primary
Phase 1: Absolute Dose Intensity
Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Population: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 1: Absolute Dose Intensity | 0.260 mg/week | Standard Deviation 0 |
| Alomfilimab 2.4 mg | Phase 1: Absolute Dose Intensity | 0.778 mg/week | Standard Deviation 0.0179 |
| Alomfilimab 8 mg | Phase 1: Absolute Dose Intensity | 2.616 mg/week | Standard Deviation 0.0427 |
| Alomfilimab 24 mg | Phase 1: Absolute Dose Intensity | 7.799 mg/week | Standard Deviation 0.2694 |
| Alomfilimab 80 mg | Phase 1: Absolute Dose Intensity | 26.174 mg/week | Standard Deviation 0.1952 |
| Alomfilimab 240 mg | Phase 1: Absolute Dose Intensity | 76.650 mg/week | Standard Deviation 4.826 |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Absolute Dose Intensity | 0.236 mg/week | Standard Deviation 0.0288 |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Absolute Dose Intensity | 0.780 mg/week | Standard Deviation 0.0176 |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Absolute Dose Intensity | 2.573 mg/week | Standard Deviation 0.1159 |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Absolute Dose Intensity | 7.418 mg/week | Standard Deviation 1.1455 |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Absolute Dose Intensity | 25.774 mg/week | Standard Deviation 0.9037 |
Primary
Phase 1: Number of Participants Experiencing Dose Changes
Dose changes were defined as infusion interruption and dose reduction.
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Population: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 0.8 mg | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 1 Participants |
| Alomfilimab 2.4 mg | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 2.4 mg | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 8 mg | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 8 mg | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 24 mg | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 24 mg | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 1 Participants |
| Alomfilimab 80 mg | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 1 Participants |
| Alomfilimab 80 mg | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 240 mg | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 240 mg | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 2 Participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Changes | Infusion Interruption | 2 Participants |
Primary
Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
A DLT was defined as a clinically relevant AE or abnormal laboratory value of Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) ≥ Grade 3 assessed as unrelated to disease, PD, inter-current illness or concomitant medications, which occurs within the first cycle (21 days) of treatment with alomfilimab as single agent or in combination with atezolizumab during the dose escalation part of the study.
Time frame: From first dose of study treatment (Day 1) up to 21 days
Population: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alomfilimab 0.8 mg | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 2.4 mg | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 8 mg | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 24 mg | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 80 mg | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 240 mg | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 Participants |
Primary
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An serious AE (SAE) was any AE that: * resulted in death; * was life-threatening; * resulted in inpatient hospitalization or prolongation of existing hospitalization; * resulted in a persistent or significant disability/incapacity; * resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs; * constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Population: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 4 Participants |
| Alomfilimab 0.8 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 1 Participants |
| Alomfilimab 2.4 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 4 Participants |
| Alomfilimab 2.4 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 1 Participants |
| Alomfilimab 8 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 8 Participants |
| Alomfilimab 8 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 3 Participants |
| Alomfilimab 24 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 7 Participants |
| Alomfilimab 24 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 2 Participants |
| Alomfilimab 80 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 7 Participants |
| Alomfilimab 80 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 3 Participants |
| Alomfilimab 240 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 2 Participants |
| Alomfilimab 240 mg | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 5 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 2 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 4 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 43 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 17 Participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 34 Participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 11 Participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 9 Participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 4 Participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any TEAEs | 9 Participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Any Serious TEAEs | 3 Participants |
Primary
Phase 1: Relative Dose Intensity
Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Population: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 1: Relative Dose Intensity | 0.988 ratio | Standard Deviation 0.0189 |
| Alomfilimab 2.4 mg | Phase 1: Relative Dose Intensity | 0.978 ratio | Standard Deviation 0.0179 |
| Alomfilimab 8 mg | Phase 1: Relative Dose Intensity | 0.979 ratio | Standard Deviation 0.0179 |
| Alomfilimab 24 mg | Phase 1: Relative Dose Intensity | 1.015 ratio | Standard Deviation 0.0835 |
| Alomfilimab 80 mg | Phase 1: Relative Dose Intensity | 0.980 ratio | Standard Deviation 0.0058 |
| Alomfilimab 240 mg | Phase 1: Relative Dose Intensity | 0.958 ratio | Standard Deviation 0.061 |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Relative Dose Intensity | 0.884 ratio | Standard Deviation 0.1071 |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Relative Dose Intensity | 0.978 ratio | Standard Deviation 0.0202 |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Relative Dose Intensity | 0.963 ratio | Standard Deviation 0.0432 |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Relative Dose Intensity | 0.928 ratio | Standard Deviation 0.1422 |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Relative Dose Intensity | 0.967 ratio | Standard Deviation 0.0316 |
Primary
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% confidence interval (CI) was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Time frame: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 162 weeks
Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with measurable disease at baseline only for the purpose of evaluating ORR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alomfilimab 0.8 mg | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 2.4 mg | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 8 mg | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 24 mg | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 7.1 percentage of participants |
| Alomfilimab 80 mg | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 240 mg | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 33.3 percentage of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | 0 percentage of participants |
Secondary
Best Overall Response (BOR) Per RECIST 1.1
BOR for each participant was defined as the best confirmed response per RECIST 1.1 among all responses recorded from start of treatment until PD, initiation of new anti-cancer therapy, death, or analysis cut-off date, whichever comes first, with responses of: CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. Not evaluable (NE).
Time frame: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alomfilimab 0.8 mg | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 0.8 mg | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 0.8 mg | Best Overall Response (BOR) Per RECIST 1.1 | SD | 1 Participants |
| Alomfilimab 0.8 mg | Best Overall Response (BOR) Per RECIST 1.1 | PD | 3 Participants |
| Alomfilimab 0.8 mg | Best Overall Response (BOR) Per RECIST 1.1 | NE | 0 Participants |
| Alomfilimab 2.4 mg | Best Overall Response (BOR) Per RECIST 1.1 | PD | 3 Participants |
| Alomfilimab 2.4 mg | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 2.4 mg | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 2.4 mg | Best Overall Response (BOR) Per RECIST 1.1 | NE | 2 Participants |
| Alomfilimab 2.4 mg | Best Overall Response (BOR) Per RECIST 1.1 | SD | 0 Participants |
| Alomfilimab 8 mg | Best Overall Response (BOR) Per RECIST 1.1 | NE | 0 Participants |
| Alomfilimab 8 mg | Best Overall Response (BOR) Per RECIST 1.1 | SD | 2 Participants |
| Alomfilimab 8 mg | Best Overall Response (BOR) Per RECIST 1.1 | PD | 7 Participants |
| Alomfilimab 8 mg | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 8 mg | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 24 mg | Best Overall Response (BOR) Per RECIST 1.1 | NE | 3 Participants |
| Alomfilimab 24 mg | Best Overall Response (BOR) Per RECIST 1.1 | PD | 3 Participants |
| Alomfilimab 24 mg | Best Overall Response (BOR) Per RECIST 1.1 | SD | 2 Participants |
| Alomfilimab 24 mg | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 24 mg | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 80 mg | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 80 mg | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 80 mg | Best Overall Response (BOR) Per RECIST 1.1 | NE | 1 Participants |
| Alomfilimab 80 mg | Best Overall Response (BOR) Per RECIST 1.1 | PD | 4 Participants |
| Alomfilimab 80 mg | Best Overall Response (BOR) Per RECIST 1.1 | SD | 2 Participants |
| Alomfilimab 240 mg | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 240 mg | Best Overall Response (BOR) Per RECIST 1.1 | PD | 4 Participants |
| Alomfilimab 240 mg | Best Overall Response (BOR) Per RECIST 1.1 | SD | 1 Participants |
| Alomfilimab 240 mg | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 240 mg | Best Overall Response (BOR) Per RECIST 1.1 | NE | 0 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | NE | 1 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PD | 1 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | SD | 3 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | CR | 1 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | SD | 12 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PD | 20 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PR | 3 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | NE | 7 Participants |
| Alomfilimab 8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PD | 22 Participants |
| Alomfilimab 8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | NE | 4 Participants |
| Alomfilimab 8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PR | 2 Participants |
| Alomfilimab 8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | SD | 8 Participants |
| Alomfilimab 8 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | NE | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PD | 7 Participants |
| Alomfilimab 24 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | SD | 1 Participants |
| Alomfilimab 24 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PR | 1 Participants |
| Alomfilimab 80 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | NE | 3 Participants |
| Alomfilimab 80 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 80 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | PD | 2 Participants |
| Alomfilimab 80 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 80 mg + Atezolizumab | Best Overall Response (BOR) Per RECIST 1.1 | SD | 4 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | SD | 6 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PD | 9 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | NE | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | SD | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | NE | 3 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | PD | 11 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | NE | 1 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | PD | 5 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | SD | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | PD | 8 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | NE | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | SD | 4 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | PR | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | SD | 2 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | NE | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PD | 2 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | SD | 1 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | NE | 2 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PD | 2 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | PD | 1 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | SD | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | NE | 1 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | PD | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | SD | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Best Overall Response (BOR) Per RECIST 1.1 | NE | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | PD | 1 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | NE | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | SD | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | SD | 2 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | PD | 3 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Best Overall Response (BOR) Per RECIST 1.1 | NE | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | NE | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PR | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | SD | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PD | 2 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | NE | 2 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PD | 4 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | PR | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | SD | 3 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Best Overall Response (BOR) Per RECIST 1.1 | CR | 0 Participants |
Secondary
Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8
Biological samples (e.g., archived and fresh tumor samples or blood samples) were collected for analysis of responsive biomarkers. The summary of change in the following markers were calculated: * FOXP3-ICOS double-positive cells per mm\^2 in the Tumor * CD8-positive cells per mm\^2 in the tumor * CD8-positive cells per mm\^2 in the invasive margin.
Time frame: Baseline and Cycle 2 Day 8 (21 day cycle length)
Population: Biomarker Evaluable Set: consisted of all participants who received at least one dose of study drug and had at least one of ICOS, FOXP3 and CD8 cells results available for analysis within the relevant phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alomfilimab 0.8 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | 0.275 cells per mm^2 | Standard Deviation 5.5649 |
| Alomfilimab 0.8 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -449.920 cells per mm^2 | — |
| Alomfilimab 2.4 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | 21.905 cells per mm^2 | Standard Deviation 30.1015 |
| Alomfilimab 2.4 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 448.833 cells per mm^2 | Standard Deviation 443.5399 |
| Alomfilimab 8 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 47.126 cells per mm^2 | Standard Deviation 294.7947 |
| Alomfilimab 8 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -50.323 cells per mm^2 | Standard Deviation 42.9514 |
| Alomfilimab 8 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the invasive margin | -229.600 cells per mm^2 | Standard Deviation 114.82 |
| Alomfilimab 24 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -42.210 cells per mm^2 | Standard Deviation 26.6714 |
| Alomfilimab 24 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -105.110 cells per mm^2 | Standard Deviation 190.2826 |
| Alomfilimab 80 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -11.532 cells per mm^2 | Standard Deviation 169.8503 |
| Alomfilimab 80 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -29.318 cells per mm^2 | Standard Deviation 28.0896 |
| Alomfilimab 80 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the invasive margin | 336.140 cells per mm^2 | — |
| Alomfilimab 240 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -67.160 cells per mm^2 | Standard Deviation 59.7524 |
| Alomfilimab 240 mg | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -371.857 cells per mm^2 | Standard Deviation 884.7449 |
| Alomfilimab 0.8 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -18.860 cells per mm^2 | Standard Deviation 33.2369 |
| Alomfilimab 0.8 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the invasive margin | -422.680 cells per mm^2 | — |
| Alomfilimab 0.8 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -218.017 cells per mm^2 | Standard Deviation 282.9603 |
| Alomfilimab 2.4 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 111.154 cells per mm^2 | Standard Deviation 939.354 |
| Alomfilimab 2.4 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -129.334 cells per mm^2 | Standard Deviation 118.334 |
| Alomfilimab 8 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -90.589 cells per mm^2 | Standard Deviation 115.9495 |
| Alomfilimab 8 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 174.339 cells per mm^2 | Standard Deviation 693.8745 |
| Alomfilimab 24 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -117.610 cells per mm^2 | Standard Deviation 174.4591 |
| Alomfilimab 24 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the invasive margin | -163.910 cells per mm^2 | — |
| Alomfilimab 24 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 300.433 cells per mm^2 | Standard Deviation 325.6656 |
| Alomfilimab 80 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 21.925 cells per mm^2 | Standard Deviation 56.3211 |
| Alomfilimab 80 mg + Atezolizumab | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -3.653 cells per mm^2 | Standard Deviation 6.5269 |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 202.501 cells per mm^2 | Standard Deviation 588.9525 |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -58.865 cells per mm^2 | Standard Deviation 65.7823 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -45.618 cells per mm^2 | Standard Deviation 34.588 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -63.528 cells per mm^2 | Standard Deviation 65.5904 |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -51.293 cells per mm^2 | Standard Deviation 56.8048 |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 318.470 cells per mm^2 | Standard Deviation 385.7782 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 320.923 cells per mm^2 | Standard Deviation 685.1093 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -76.331 cells per mm^2 | Standard Deviation 63.0946 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -437.660 cells per mm^2 | — |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -116.950 cells per mm^2 | — |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -1009.800 cells per mm^2 | — |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -518.975 cells per mm^2 | Standard Deviation 668.5624 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -34.840 cells per mm^2 | — |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -31.120 cells per mm^2 | — |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 181.120 cells per mm^2 | Standard Deviation 147.3752 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -149.445 cells per mm^2 | Standard Deviation 137.0019 |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -197.940 cells per mm^2 | — |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | -39.600 cells per mm^2 | — |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | CD8-positive cells per mm^2 in the tumor | 171.170 cells per mm^2 | Standard Deviation 293.3937 |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8 | FOXP3-ICOS double-positive cells per mm^2 in the tumor | -397.437 cells per mm^2 | Standard Deviation 307.3676 |
Secondary
Duration of Response Per RECIST 1.1
Duration of response was calculated as (date of the first documentation of PD or to death due to any cause in the absence of PD - date of the first documentation of unconfirmed objective response \[CR or PR\] + 1\]/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants with no disease assessment (or only had assessments with response = NE) after first study treatment or have baseline or post-baseline assessments where the RECIST criteria could not be applied had their duration of response time censored. Duration of response was obtained via Kaplan Meier estimation.
Time frame: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with observed events or participants that were censored for the purpose of evaluating duration of response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alomfilimab 0.8 mg + Atezolizumab | Duration of Response Per RECIST 1.1 | 11 months |
| Alomfilimab 2.4 mg + Atezolizumab | Duration of Response Per RECIST 1.1 | 6 months |
| Alomfilimab 8 mg + Atezolizumab | Duration of Response Per RECIST 1.1 | NA months |
| Alomfilimab 24 mg + Atezolizumab | Duration of Response Per RECIST 1.1 | 11 months |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Duration of Response Per RECIST 1.1 | 2 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Duration of Response Per RECIST 1.1 | 13 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Duration of Response Per RECIST 1.1 | NA months |
Secondary
Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime
Detection of ADA was assessed from blood samples taken during the study using validated bioanalytical methods. The number of participants who developed detectable anti-alomfilimab or anti-atezolizumab antibodies during any cycle or the safety follow-up period (SFUP) was calculated.
Time frame: Phase 1: pre-infusion at all cycles (up to 69 cycles) + 90 days SFUP; Phase 2: pre-infusion at all cycles (up to 28 cycles) + 90 day SFUP (21 day cycle length)
Population: Anti-drug Antibody Evaluable Set: consisted of all participants who received at least one dose of alomfilimab or atezolizumab and had ADA results available for analysis within the relevant phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alomfilimab 0.8 mg | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 1 Participants |
| Alomfilimab 2.4 mg | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 0 Participants |
| Alomfilimab 8 mg | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 2 Participants |
| Alomfilimab 24 mg | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 1 Participants |
| Alomfilimab 80 mg | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 1 Participants |
| Alomfilimab 240 mg | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 0 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 2 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 1 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 8 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 9 Participants |
| Alomfilimab 8 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 8 Participants |
| Alomfilimab 8 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 8 Participants |
| Alomfilimab 24 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 4 Participants |
| Alomfilimab 24 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 0 Participants |
| Alomfilimab 80 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 1 Participants |
| Alomfilimab 80 mg + Atezolizumab | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 5 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 2 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 2 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 1 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 3 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 1 Participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-alomfilimab Antibodies Result | 1 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime | ≥ 1 Positive Anti-atezolizumab Antibodies Result | 1 Participants |
Secondary
ORR Per iRECIST
RECIST 1.1 has been modified to take into consideration the unique response kinetics which have been observed with immunotherapy in some patients where responses to immune therapies may occur after progression has been assessed. ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete immune-response (iCR) or partial immune-response (iPR) according to iRECIST as the best response. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). iCR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). iPR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Time frame: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with measurable disease at baseline only for the purpose of evaluating ORR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alomfilimab 0.8 mg | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 2.4 mg | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 8 mg | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 24 mg | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 80 mg | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 240 mg | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 0.8 mg + Atezolizumab | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 2.4 mg + Atezolizumab | ORR Per iRECIST | 9.3 percentage of participants |
| Alomfilimab 8 mg + Atezolizumab | ORR Per iRECIST | 5.6 percentage of participants |
| Alomfilimab 24 mg + Atezolizumab | ORR Per iRECIST | 11.1 percentage of participants |
| Alomfilimab 80 mg + Atezolizumab | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | ORR Per iRECIST | 7.1 percentage of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | ORR Per iRECIST | 0 percentage of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | ORR Per iRECIST | 33.3 percentage of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | ORR Per iRECIST | 0 percentage of participants |
Secondary
Overall Survival Rate at 12 and 24 Months
Overall Survival rate was defined as the proportion of participants that had known survival status. Overall survival rate was obtained via Kaplan Meier estimation using the complimentary log-log transformation method.
Time frame: Months 12 and 24
Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alomfilimab 0.8 mg | Overall Survival Rate at 12 and 24 Months | 12 months | 0.0 proportion of participants |
| Alomfilimab 0.8 mg | Overall Survival Rate at 12 and 24 Months | 24 months | 0.0 proportion of participants |
| Alomfilimab 2.4 mg | Overall Survival Rate at 12 and 24 Months | 24 months | 0.2 proportion of participants |
| Alomfilimab 2.4 mg | Overall Survival Rate at 12 and 24 Months | 12 months | 0.2 proportion of participants |
| Alomfilimab 8 mg | Overall Survival Rate at 12 and 24 Months | 24 months | 0.3 proportion of participants |
| Alomfilimab 8 mg | Overall Survival Rate at 12 and 24 Months | 12 months | 0.4 proportion of participants |
| Alomfilimab 24 mg | Overall Survival Rate at 12 and 24 Months | 12 months | 0.3 proportion of participants |
| Alomfilimab 24 mg | Overall Survival Rate at 12 and 24 Months | 24 months | NA proportion of participants |
| Alomfilimab 80 mg | Overall Survival Rate at 12 and 24 Months | 24 months | 0.0 proportion of participants |
| Alomfilimab 80 mg | Overall Survival Rate at 12 and 24 Months | 12 months | 0.4 proportion of participants |
| Alomfilimab 240 mg | Overall Survival Rate at 12 and 24 Months | 12 months | 0.0 proportion of participants |
| Alomfilimab 240 mg | Overall Survival Rate at 12 and 24 Months | 24 months | 0.0 proportion of participants |
| Alomfilimab 0.8 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 12 months | 0.4 proportion of participants |
| Alomfilimab 0.8 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 24 months | 0.0 proportion of participants |
| Alomfilimab 2.4 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 24 months | 0.3 proportion of participants |
| Alomfilimab 2.4 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 12 months | 0.4 proportion of participants |
| Alomfilimab 8 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 24 months | 0.3 proportion of participants |
| Alomfilimab 8 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 12 months | 0.4 proportion of participants |
| Alomfilimab 24 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 12 months | 0.2 proportion of participants |
| Alomfilimab 24 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 24 months | 0.0 proportion of participants |
| Alomfilimab 80 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 12 months | 0.5 proportion of participants |
| Alomfilimab 80 mg + Atezolizumab | Overall Survival Rate at 12 and 24 Months | 24 months | NA proportion of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Overall Survival Rate at 12 and 24 Months | 12 months | 0.2 proportion of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Overall Survival Rate at 12 and 24 Months | 24 months | 0.0 proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Overall Survival Rate at 12 and 24 Months | 24 months | 0.0 proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Overall Survival Rate at 12 and 24 Months | 12 months | 0.0 proportion of participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Overall Survival Rate at 12 and 24 Months | 24 months | 0.2 proportion of participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Overall Survival Rate at 12 and 24 Months | 12 months | 0.6 proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Overall Survival Rate at 12 and 24 Months | 12 months | 0.7 proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Overall Survival Rate at 12 and 24 Months | 24 months | 0.4 proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Overall Survival Rate at 12 and 24 Months | 24 months | NA proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Overall Survival Rate at 12 and 24 Months | 12 months | NA proportion of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Overall Survival Rate at 12 and 24 Months | 24 months | NA proportion of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Overall Survival Rate at 12 and 24 Months | 12 months | NA proportion of participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Overall Survival Rate at 12 and 24 Months | 24 months | NA proportion of participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Overall Survival Rate at 12 and 24 Months | 12 months | NA proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Overall Survival Rate at 12 and 24 Months | 24 months | 0.0 proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Overall Survival Rate at 12 and 24 Months | 12 months | 0.0 proportion of participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Overall Survival Rate at 12 and 24 Months | 24 months | 0.0 proportion of participants |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Overall Survival Rate at 12 and 24 Months | 12 months | NA proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Overall Survival Rate at 12 and 24 Months | 24 months | NA proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Overall Survival Rate at 12 and 24 Months | 12 months | NA proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Overall Survival Rate at 12 and 24 Months | 12 months | 0.3 proportion of participants |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Overall Survival Rate at 12 and 24 Months | 24 months | NA proportion of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Overall Survival Rate at 12 and 24 Months | 24 months | NA proportion of participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Overall Survival Rate at 12 and 24 Months | 12 months | NA proportion of participants |
Secondary
PFS Per iRECIST
PFS was calculated as (first documented iPD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. iPD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Time frame: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with observed events or participants that were censored for the purpose of evaluating PFS.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alomfilimab 0.8 mg | PFS Per iRECIST | 7 months |
| Alomfilimab 2.4 mg | PFS Per iRECIST | 10 months |
| Alomfilimab 8 mg | PFS Per iRECIST | 10 months |
| Alomfilimab 24 mg | PFS Per iRECIST | 6 months |
| Alomfilimab 80 mg | PFS Per iRECIST | 6 months |
| Alomfilimab 240 mg | PFS Per iRECIST | 6 months |
| Alomfilimab 0.8 mg + Atezolizumab | PFS Per iRECIST | 4 months |
| Alomfilimab 2.4 mg + Atezolizumab | PFS Per iRECIST | 7 months |
| Alomfilimab 8 mg + Atezolizumab | PFS Per iRECIST | 5 months |
| Alomfilimab 24 mg + Atezolizumab | PFS Per iRECIST | 3 months |
| Alomfilimab 80 mg + Atezolizumab | PFS Per iRECIST | 5 months |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | PFS Per iRECIST | 5 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | PFS Per iRECIST | 5 months |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | PFS Per iRECIST | 4 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | PFS Per iRECIST | 10 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | PFS Per iRECIST | 5 months |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | PFS Per iRECIST | 4 months |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | PFS Per iRECIST | NA months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | PFS Per iRECIST | 10 months |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | PFS Per iRECIST | 17 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | PFS Per iRECIST | 12 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | PFS Per iRECIST | NA months |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | PFS Per iRECIST | 6 months |
Secondary
Phase 1: Half-life (t1/2) of Alomfilimab
The serum PK of alomfilimab were characterized using NCA. Nominal times of sample collections were used for the NCA. All BLQ values were set to 0 units.
Time frame: Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)
Population: PK Evaluable Set: consisted of all participants who had sufficient concentration-time data within the relevant phase to permit calculation of PK parameters for alomfilimab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 42.7633 hours | Standard Deviation 20.84762 |
| Alomfilimab 2.4 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 72.2276 hours | Standard Deviation 9.56084 |
| Alomfilimab 2.4 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 3 | 80.3268 hours | — |
| Alomfilimab 8 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 3 | 215.6472 hours | Standard Deviation 98.90118 |
| Alomfilimab 8 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 149.0872 hours | Standard Deviation 55.14152 |
| Alomfilimab 24 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 3 | 358.6064 hours | Standard Deviation 143.16181 |
| Alomfilimab 24 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 226.2922 hours | Standard Deviation 75.20291 |
| Alomfilimab 80 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 3 | 342.6067 hours | Standard Deviation 193.81667 |
| Alomfilimab 80 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 377.5444 hours | Standard Deviation 126.28273 |
| Alomfilimab 240 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 3 | 273.6673 hours | — |
| Alomfilimab 240 mg | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 356.4297 hours | Standard Deviation 109.9645 |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 37.4777 hours | Standard Deviation 3.96733 |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 3 | 116.0599 hours | Standard Deviation 42.16269 |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 93.0339 hours | Standard Deviation 33.82676 |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 3 | 202.0099 hours | Standard Deviation 78.48781 |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 165.8783 hours | Standard Deviation 89.07566 |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 174.9685 hours | Standard Deviation 79.39134 |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 3 | 230.5514 hours | Standard Deviation 103.13822 |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 3 | 440.0235 hours | Standard Deviation 236.99886 |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Half-life (t1/2) of Alomfilimab | Cycle 1 | 300.0089 hours | Standard Deviation 113.4991 |
Secondary
Phase 1: Maximum Concentration (Cmax) of Alomfilimab
The serum pharmacokinetics (PK) of alomfilimab were characterized using non-compartmental analysis (NCA). Nominal times of sample collections were used for the NCA. All below limit of quantification (BLQ) values were set to 0 units.
Time frame: Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)
Population: PK Evaluable Set: consisted of all participants who had sufficient concentration-time data within the relevant phase to permit calculation of PK parameters for alomfilimab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 0.3022 ug/mL | Standard Deviation 0.12476 |
| Alomfilimab 0.8 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 0.2671 ug/mL | Standard Deviation 0.06805 |
| Alomfilimab 2.4 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 0.9773 ug/mL | Standard Deviation 0.29919 |
| Alomfilimab 2.4 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 1.2029 ug/mL | Standard Deviation 0.24583 |
| Alomfilimab 8 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 3.3327 ug/mL | Standard Deviation 0.95752 |
| Alomfilimab 8 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 3.7461 ug/mL | Standard Deviation 0.86853 |
| Alomfilimab 24 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 8.7301 ug/mL | Standard Deviation 2.84671 |
| Alomfilimab 24 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 30.5647 ug/mL | Standard Deviation 39.72256 |
| Alomfilimab 80 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 33.7844 ug/mL | Standard Deviation 12.98646 |
| Alomfilimab 80 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 43.8045 ug/mL | Standard Deviation 14.07259 |
| Alomfilimab 240 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 141.8131 ug/mL | Standard Deviation 62.54794 |
| Alomfilimab 240 mg | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 124.4294 ug/mL | Standard Deviation 79.79754 |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 0.2840 ug/mL | Standard Deviation 0.24914 |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 0.3339 ug/mL | Standard Deviation 0.17905 |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 1.1201 ug/mL | Standard Deviation 0.66885 |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 1.6449 ug/mL | Standard Deviation 3.0138 |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 3.3476 ug/mL | Standard Deviation 1.23416 |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 9.5099 ug/mL | Standard Deviation 28.23379 |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 8.2597 ug/mL | Standard Deviation 2.75396 |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 10.2883 ug/mL | Standard Deviation 3.86029 |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 1 | 31.4793 ug/mL | Standard Deviation 10.38008 |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: Maximum Concentration (Cmax) of Alomfilimab | Cycle 3 | 51.6622 ug/mL | Standard Deviation 41.65071 |
Secondary
Phase 1: ORR Per RECIST 1.1
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of CR or PR according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Time frame: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 weeks
Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. Inclusive of participants with measurable disease at baseline only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alomfilimab 0.8 mg | Phase 1: ORR Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 2.4 mg | Phase 1: ORR Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 8 mg | Phase 1: ORR Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 24 mg | Phase 1: ORR Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 80 mg | Phase 1: ORR Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 240 mg | Phase 1: ORR Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 1: ORR Per RECIST 1.1 | 0 percentage of participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 1: ORR Per RECIST 1.1 | 9.3 percentage of participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 1: ORR Per RECIST 1.1 | 5.6 percentage of participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 1: ORR Per RECIST 1.1 | 11.1 percentage of participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 1: ORR Per RECIST 1.1 | 0 percentage of participants |
Secondary
Phase 2: Absolute Dose Intensity
Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Population: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 2: Absolute Dose Intensity | 0.778 mg/week | Standard Deviation 0.054 |
| Alomfilimab 2.4 mg | Phase 2: Absolute Dose Intensity | 2.559 mg/week | Standard Deviation 0.1712 |
| Alomfilimab 8 mg | Phase 2: Absolute Dose Intensity | 0.777 mg/week | Standard Deviation 0.0111 |
| Alomfilimab 24 mg | Phase 2: Absolute Dose Intensity | 2.536 mg/week | Standard Deviation 0.1628 |
| Alomfilimab 80 mg | Phase 2: Absolute Dose Intensity | 2.366 mg/week | Standard Deviation 0.3577 |
| Alomfilimab 240 mg | Phase 2: Absolute Dose Intensity | 6.818 mg/week | Standard Deviation 2.3926 |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 2: Absolute Dose Intensity | 0.775 mg/week | Standard Deviation 0.0212 |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 2: Absolute Dose Intensity | 2.640 mg/week | — |
| Alomfilimab 8 mg + Atezolizumab | Phase 2: Absolute Dose Intensity | 0.760 mg/week | — |
| Alomfilimab 24 mg + Atezolizumab | Phase 2: Absolute Dose Intensity | 2.607 mg/week | Standard Deviation 0.0841 |
| Alomfilimab 80 mg + Atezolizumab | Phase 2: Absolute Dose Intensity | 2.613 mg/week | Standard Deviation 0.0551 |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Phase 2: Absolute Dose Intensity | 7.794 mg/week | Standard Deviation 0.1676 |
Secondary
Phase 2: Number of Participants Experiencing Dose Changes
Dose changes were defined as infusion interruption and dose reduction.
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Population: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 0.8 mg | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 2.4 mg | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 2.4 mg | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 8 mg | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 8 mg | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 24 mg | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 24 mg | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 2 Participants |
| Alomfilimab 80 mg | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 1 Participants |
| Alomfilimab 80 mg | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 240 mg | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 1 Participants |
| Alomfilimab 240 mg | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 1 Participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 1 Participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Phase 2: Number of Participants Experiencing Dose Changes | Dose Reduction | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Phase 2: Number of Participants Experiencing Dose Changes | Infusion Interruption | 0 Participants |
Secondary
Phase 2: Number of Participants Experiencing TEAEs
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An SAE was any AE that: * resulted in death; * was life-threatening; * resulted in inpatient hospitalization or prolongation of existing hospitalization; * resulted in a persistent or significant disability/incapacity; * resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs; * constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Population: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 15 Participants |
| Alomfilimab 0.8 mg | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 6 Participants |
| Alomfilimab 2.4 mg | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 13 Participants |
| Alomfilimab 2.4 mg | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 2 Participants |
| Alomfilimab 8 mg | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 7 Participants |
| Alomfilimab 8 mg | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 1 Participants |
| Alomfilimab 24 mg | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 14 Participants |
| Alomfilimab 24 mg | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 2 Participants |
| Alomfilimab 80 mg | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 1 Participants |
| Alomfilimab 80 mg | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 5 Participants |
| Alomfilimab 240 mg | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 5 Participants |
| Alomfilimab 240 mg | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 1 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 1 Participants |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 2 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 1 Participants |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 0 Participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 1 Participants |
| Alomfilimab 8 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 0 Participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 6 Participants |
| Alomfilimab 24 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 2 Participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 1 Participants |
| Alomfilimab 80 mg + Atezolizumab | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 3 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Phase 2: Number of Participants Experiencing TEAEs | Any Serious TEAEs | 4 Participants |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Phase 2: Number of Participants Experiencing TEAEs | Any TEAEs | 8 Participants |
Secondary
Phase 2: Relative Dose Intensity
Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Population: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alomfilimab 0.8 mg | Phase 2: Relative Dose Intensity | 0.973 ratio | Standard Deviation 0.066 |
| Alomfilimab 2.4 mg | Phase 2: Relative Dose Intensity | 0.956 ratio | Standard Deviation 0.0638 |
| Alomfilimab 8 mg | Phase 2: Relative Dose Intensity | 0.976 ratio | Standard Deviation 0.0113 |
| Alomfilimab 24 mg | Phase 2: Relative Dose Intensity | 1.014 ratio | Standard Deviation 0.1256 |
| Alomfilimab 80 mg | Phase 2: Relative Dose Intensity | 0.886 ratio | Standard Deviation 0.1316 |
| Alomfilimab 240 mg | Phase 2: Relative Dose Intensity | 0.980 ratio | Standard Deviation 0.0274 |
| Alomfilimab 0.8 mg + Atezolizumab | Phase 2: Relative Dose Intensity | 0.975 ratio | Standard Deviation 0.0212 |
| Alomfilimab 2.4 mg + Atezolizumab | Phase 2: Relative Dose Intensity | 0.990 ratio | — |
| Alomfilimab 8 mg + Atezolizumab | Phase 2: Relative Dose Intensity | 0.960 ratio | — |
| Alomfilimab 24 mg + Atezolizumab | Phase 2: Relative Dose Intensity | 0.977 ratio | Standard Deviation 0.0333 |
| Alomfilimab 80 mg + Atezolizumab | Phase 2: Relative Dose Intensity | 0.980 ratio | Standard Deviation 0.02 |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Phase 2: Relative Dose Intensity | 0.973 ratio | Standard Deviation 0.0191 |
Secondary
Progression-free Survival (PFS) Per RECIST 1.1
PFS was calculated as (first documented PD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Time frame: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with observed events or participants that were censored for the purpose of evaluating PFS.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alomfilimab 0.8 mg | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 2.4 mg | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 8 mg | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 24 mg | Progression-free Survival (PFS) Per RECIST 1.1 | 3 months |
| Alomfilimab 80 mg | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 240 mg | Progression-free Survival (PFS) Per RECIST 1.1 | 1 months |
| Alomfilimab 0.8 mg + Atezolizumab | Progression-free Survival (PFS) Per RECIST 1.1 | 3 months |
| Alomfilimab 2.4 mg + Atezolizumab | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 8 mg + Atezolizumab | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 24 mg + Atezolizumab | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 80 mg + Atezolizumab | Progression-free Survival (PFS) Per RECIST 1.1 | 4 months |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Progression-free Survival (PFS) Per RECIST 1.1 | 4 months |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | Progression-free Survival (PFS) Per RECIST 1.1 | 3 months |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | Progression-free Survival (PFS) Per RECIST 1.1 | 4 months |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Progression-free Survival (PFS) Per RECIST 1.1 | 2 months |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | Progression-free Survival (PFS) Per RECIST 1.1 | 3 months |