A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies

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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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

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]. Count Of Participants, Participants. Any TEAEs: Alomfilimab 0.8 mg (n=4): 4; Alomfilimab 2.4 mg (n=5): 4; Alomfilimab 8 mg (n=10): 8; Alomfilimab 24 mg (n=8): 7; Alomfilimab 80 mg (n=7): 7; Alomfilimab 240 mg (n=5): 5; Alomfilimab 0.8 mg + Atezolizumab (n=5): 4; Alomfilimab 2.4 mg + Atezolizumab (n=43): 43; Alomfilimab 8 mg + Atezolizumab (n=35): 34; Alomfilimab 24 mg + Atezolizumab (n=9): 9; Alomfilimab 80 mg + Atezolizumab (n=9): 9. Any Serious TEAEs: Alomfilimab 0.8 mg (n=4): 1; Alomfilimab 2.4 mg (n=5): 1; Alomfilimab 8 mg (n=10): 3; Alomfilimab 24 mg (n=8): 2; Alomfilimab 80 mg (n=7): 3; Alomfilimab 240 mg (n=5): 2; Alomfilimab 0.8 mg + Atezolizumab (n=5): 2; Alomfilimab 2.4 mg + Atezolizumab (n=43): 17; Alomfilimab 8 mg + Atezolizumab (n=35): 11; Alomfilimab 24 mg + Atezolizumab (n=9): 4; Alomfilimab 80 mg + Atezolizumab (n=9): 3.

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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]. Count Of Participants, Participants. Infusion Interruption: Alomfilimab 0.8 mg (n=4): 1; Alomfilimab 2.4 mg (n=5): 0; Alomfilimab 8 mg (n=10): 0; Alomfilimab 24 mg (n=8): 1; Alomfilimab 80 mg (n=7): 1; Alomfilimab 240 mg (n=5): 0; Alomfilimab 0.8 mg + Atezolizumab (n=5): 0; Alomfilimab 2.4 mg + Atezolizumab (n=43): 2; Alomfilimab 8 mg + Atezolizumab (n=35): 0; Alomfilimab 24 mg + Atezolizumab (n=9): 0; Alomfilimab 80 mg + Atezolizumab (n=9): 2. Dose Reduction: Alomfilimab 0.8 mg (n=4): 0; Alomfilimab 2.4 mg (n=5): 0; Alomfilimab 8 mg (n=10): 0; Alomfilimab 24 mg (n=8): 0; Alomfilimab 80 mg (n=7): 0; Alomfilimab 240 mg (n=5): 0; Alomfilimab 0.8 mg + Atezolizumab (n=5): 0; Alomfilimab 2.4 mg + Atezolizumab (n=43): 0; Alomfilimab 8 mg + Atezolizumab (n=35): 0; Alomfilimab 24 mg + Atezolizumab (n=9): 0; Alomfilimab 80 mg + Atezolizumab (n=9): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

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]. Mean, mg/week (Standard Deviation). Alomfilimab 0.8 mg (n=4): 0.260 (0.0000); Alomfilimab 2.4 mg (n=5): 0.778 (0.0179); Alomfilimab 8 mg (n=10): 2.616 (0.0427); Alomfilimab 24 mg (n=8): 7.799 (0.2694); Alomfilimab 80 mg (n=7): 26.174 (0.1952); Alomfilimab 240 mg (n=5): 76.650 (4.8260); Alomfilimab 0.8 mg + Atezolizumab (n=5): 0.236 (0.0288); Alomfilimab 2.4 mg + Atezolizumab (n=43): 0.780 (0.0176); Alomfilimab 8 mg + Atezolizumab (n=35): 2.573 (0.1159); Alomfilimab 24 mg + Atezolizumab (n=9): 7.418 (1.1455); Alomfilimab 80 mg + Atezolizumab (n=9): 25.774 (0.9037).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

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]. Mean, ratio (Standard Deviation). Alomfilimab 0.8 mg (n=4): 0.988 (0.0189); Alomfilimab 2.4 mg (n=5): 0.978 (0.0179); Alomfilimab 8 mg (n=10): 0.979 (0.0179); Alomfilimab 24 mg (n=8): 1.015 (0.0835); Alomfilimab 80 mg (n=7): 0.980 (0.0058); Alomfilimab 240 mg (n=5): 0.958 (0.0610); Alomfilimab 0.8 mg + Atezolizumab (n=5): 0.884 (0.1071); Alomfilimab 2.4 mg + Atezolizumab (n=43): 0.978 (0.0202); Alomfilimab 8 mg + Atezolizumab (n=35): 0.963 (0.0432); Alomfilimab 24 mg + Atezolizumab (n=9): 0.928 (0.1422); Alomfilimab 80 mg + Atezolizumab (n=9): 0.967 (0.0316).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) [From first dose of study treatment (Day 1) up to 21 days]. Count Of Participants, Participants. Alomfilimab 0.8 mg (n=4): 0; Alomfilimab 2.4 mg (n=5): 0; Alomfilimab 8 mg (n=10): 0; Alomfilimab 24 mg (n=8): 0; Alomfilimab 80 mg (n=7): 0; Alomfilimab 240 mg (n=5): 0; Alomfilimab 0.8 mg + Atezolizumab (n=5): 0; Alomfilimab 2.4 mg + Atezolizumab (n=43): 0; Alomfilimab 8 mg + Atezolizumab (n=35): 0; Alomfilimab 24 mg + Atezolizumab (n=9): 0; Alomfilimab 80 mg + Atezolizumab (n=9): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

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]. Number, percentage of participants (95% Confidence Interval). Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 0 (0.0 to 21.8); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 0 (0.0 to 28.5); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 0 (0.0 to 45.9); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 7.1 (0.2 to 36.0); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0 (0.0 to 60.2); Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0 (0.0 to 70.8); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 0 (0.0 to 97.5); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0 (0.0 to 97.5); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 0 (0.0 to 97.5); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 0 (0.0 to 52.2); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 33.3 (0.8 to 90.6); Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=8): 0 (0.0 to 41.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Count Of Participants, Participants. CR: Alomfilimab 0.8 mg (n=4): 0; Alomfilimab 2.4 mg (n=5): 0; Alomfilimab 8 mg (n=9): 0; Alomfilimab 24 mg (n=8): 0; Alomfilimab 80 mg (n=7): 0; Alomfilimab 240 mg (n=5): 0; Alomfilimab 0.8 mg + Atezolizumab (n=5): 0; Alomfilimab 2.4 mg + Atezolizumab (n=43): 1; Alomfilimab 8 mg + Atezolizumab (n=36): 0; Alomfilimab 24 mg + Atezolizumab (n=9): 0; Alomfilimab 80 mg + Atezolizumab (n=9): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 0; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=9): 0. PR: Alomfilimab 0.8 mg (n=4): 0; Alomfilimab 2.4 mg (n=5): 0; Alomfilimab 8 mg (n=9): 0; Alomfilimab 24 mg (n=8): 0; Alomfilimab 80 mg (n=7): 0; Alomfilimab 240 mg (n=5): 0; Alomfilimab 0.8 mg + Atezolizumab (n=5): 0; Alomfilimab 2.4 mg + Atezolizumab (n=43): 3; Alomfilimab 8 mg + Atezolizumab (n=36): 2; Alomfilimab 24 mg + Atezolizumab (n=9): 1; Alomfilimab 80 mg + Atezolizumab (n=9): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 1; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 1; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=9): 0. SD: Al

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Median, months (95% Confidence Interval). Alomfilimab 0.8 mg (n=4): 2 (2 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 2.4 mg (n=5): 2 (1 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 8 mg (n=9): 2 (1 to 6); Alomfilimab 24 mg (n=8): 3 (1 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 80 mg (n=7): 2 (1 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 240 mg (n=5): 1 (1 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 0.8 mg + Atezolizumab (n=5): 3 (2 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 2.4 mg + Atezolizumab (n=43): 2 (2 to 4); Alomfilimab 8 mg + Atezolizumab (n=36): 2 (2 to 2); Alomfilimab 24 mg + Atezolizumab (n=9): 2 (1 to 4); Alomfilimab 80 mg + Atezolizumab (n=9): 4 (2 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 2 (1 to 4); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 2 (2 to 2); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 2 (1 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 2 (1 to 4); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 4 (2 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 2 (1 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 2 (NA to NA) [Confidence intervals were not calculable due to insufficient event data occurring near the median.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 3 (NA to NA) [Confidence intervals were not calculable due to insufficient event data occurring near the median.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 2 (NA to NA) [Confidence intervals were not calculable due to insufficient event data occurring near the median.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Tripl

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Median, months (95% Confidence Interval). Alomfilimab 0.8 mg + Atezolizumab (n=1): 11 (NA to NA) [Confidence intervals could not be calculated as a single participant was analyzed.]; Alomfilimab 2.4 mg + Atezolizumab (n=5): 6 (2.1 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 8 mg + Atezolizumab (n=2): NA (13.9 to NA) [Median and upper confidence intervals were not calculable due to fewer than 50% events.]; Alomfilimab 24 mg + Atezolizumab (n=1): 11 (NA to NA) [Confidence intervals could not be calculated as a single participant was analyzed.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=1): 2 (NA to NA) [Confidence intervals could not be calculated as a single participant was analyzed.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=1): 13 (NA to NA) [Confidence intervals could not be calculated as a single participant was analyzed.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=1): NA (NA to NA) [Median and confidence intervals could not be calculated as a single participant was censored.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Number, percentage of participants (95% Confidence Interval). Alomfilimab 0.8 mg (n=4): 0 (0.0 to 60.2); Alomfilimab 2.4 mg (n=5): 0 (0.0 to 70.8); Alomfilimab 8 mg (n=8): 0 (0.0 to 33.6); Alomfilimab 24 mg (n=8): 0 (0.0 to 52.2); Alomfilimab 80 mg (n=7): 0 (0.0 to 45.9); Alomfilimab 240 mg (n=5): 0 (0.0 to 52.2); Alomfilimab 0.8 mg + Atezolizumab (n=4): 0 (0.0 to 60.2); Alomfilimab 2.4 mg + Atezolizumab (n=41): 9.3 (3.1 to 26.1); Alomfilimab 8 mg + Atezolizumab (n=36): 5.6 (0.8 to 21.4); Alomfilimab 24 mg + Atezolizumab (n=9): 11.1 (0.3 to 48.2); Alomfilimab 80 mg + Atezolizumab (n=9): 0 (0.0 to 45.9); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 0 (0.0 to 23.2); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 0 (0.0 to 30.8); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 0 (0.0 to 45.9); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 7.1 (0.2 to 38.5); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0 (0.0 to 60.2); Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0 (0.0 to 70.8); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 0 (0.0 to 97.5); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0 (0.0 to 97.5); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 0 (0.0 to 97.5); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 0 (0.0 to 52.2); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 33.3 (2.5 to 100.0); Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=8): 0 (0.0 to 41.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Median, months (95% Confidence Interval). Alomfilimab 0.8 mg (n=4): 7 (NA to NA) [Confidence intervals could not be calculated as a single participant had observed events.]; Alomfilimab 2.4 mg (n=5): 10 (4.2 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 8 mg (n=9): 10 (3.4 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 24 mg (n=8): 6 (3.3 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 80 mg (n=7): 6 (2.7 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 240 mg (n=5): 6 (3.4 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 0.8 mg + Atezolizumab (n=5): 4 (2.5 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 2.4 mg + Atezolizumab (n=43): 7 (5.5 to 10.0); Alomfilimab 8 mg + Atezolizumab (n=36): 5 (2.8 to 9.9); Alomfilimab 24 mg + Atezolizumab (n=9): 3 (1.8 to 4.0); Alomfilimab 80 mg + Atezolizumab (n=9): 5 (4.6 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 5 (2.5 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 5 (2.7 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 4 (2.6 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 10 (1.7 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 5 (5.0 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 4 (1.5 to NA) [Upper confidence interval was not calculable due to insufficient event data occurring above the median.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): NA (NA to NA) [Median and confidence intervals could not be calculated as two participants were censored.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 P

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Number, percentage of participants (95% Confidence Interval). Alomfilimab 0.8 mg (n=4): 0 (0.0 to 60.2); Alomfilimab 2.4 mg (n=5): 0 (0.0 to 70.8); Alomfilimab 8 mg (n=8): 0 (0.0 to 33.6); Alomfilimab 24 mg (n=8): 0 (0.0 to 52.2); Alomfilimab 80 mg (n=7): 0 (0.0 to 45.9); Alomfilimab 240 mg (n=5): 0 (0.0 to 52.2); Alomfilimab 0.8 mg + Atezolizumab (n=4): 0 (0.0 to 60.2); Alomfilimab 2.4 mg + Atezolizumab (n=41): 9.3 (3.1 to 26.1); Alomfilimab 8 mg + Atezolizumab (n=36): 5.6 (0.8 to 20.8); Alomfilimab 24 mg + Atezolizumab (n=9): 11.1 (0.3 to 48.2); Alomfilimab 80 mg + Atezolizumab (n=9): 0 (0.0 to 45.9).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival Rate at 12 and 24 Months [Months 12 and 24]. Number, proportion of participants (95% Confidence Interval). 12 months: Alomfilimab 0.8 mg (n=4): 0.0 (NA to NA) [Confidence intervals could not be calculated as no participants had known survival status at 12 months.]; Alomfilimab 2.4 mg (n=5): 0.2 (0.01 to 0.58); Alomfilimab 8 mg (n=9): 0.4 (0.10 to 0.73); Alomfilimab 24 mg (n=8): 0.3 (0.04 to 0.56); Alomfilimab 80 mg (n=7): 0.4 (0.10 to 0.73); Alomfilimab 240 mg (n=5): 0.0 (NA to NA) [Confidence intervals could not be calculated as no participants had known survival status at 12 months.]; Alomfilimab 0.8 mg + Atezolizumab (n=5): 0.4 (0.05 to 0.75); Alomfilimab 2.4 mg + Atezolizumab (n=43): 0.4 (0.27 to 0.60); Alomfilimab 8 mg + Atezolizumab (n=36): 0.4 (0.22 to 0.57); Alomfilimab 24 mg + Atezolizumab (n=9): 0.2 (0.01 to 0.64); Alomfilimab 80 mg + Atezolizumab (n=9): 0.5 (0.12 to 0.82); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 0.2 (0.03 to 0.47); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 0.0 (NA to NA) [Confidence intervals could not be calculated as no participants had known survival status at 12 months.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 0.6 (0.17 to 0.84); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 0.7 (0.38 to 0.88); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): NA (NA to NA) [Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.]; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): NA (NA to NA) [Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): NA (NA to NA) [Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0.0 (NA to NA) [Confidence intervals could not be calculated as no participants had known survival status at 12 months.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): NA (NA to NA) [Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): NA (NA to NA) [Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 0.3 (0.01 to 0.77); Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=9): NA (NA to NA) [Numb

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Count Of Participants, Participants. Any TEAEs: Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 15; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 13; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 7; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 14; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 5; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 5; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 2; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 1; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 1; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 6; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 3; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=8): 8. Any Serious TEAEs: Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 6; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 2; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 1; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 2; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 1; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 1; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 1; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 2; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 1; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=8): 4.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Count Of Participants, Participants. Infusion Interruption: Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 1; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 1; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 1; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=8): 0. Dose Reduction: Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 2; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 1; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 0; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=8): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Mean, mg/week (Standard Deviation). Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 0.778 (0.0540); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 2.559 (0.1712); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 0.777 (0.0111); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 2.536 (0.1628); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 2.366 (0.3577); Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 6.818 (2.3926); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 0.775 (0.0212); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 2.640 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 0.760 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 2.607 (0.0841); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 2.613 (0.0551); Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=8): 7.794 (0.1676).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Mean, ratio (Standard Deviation). Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=15): 0.973 (0.0660); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=14): 0.956 (0.0638); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=7): 0.976 (0.0113); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=14): 1.014 (0.1256); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0.886 (0.1316); Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 0.980 (0.0274); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=2): 0.975 (0.0212); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0.990 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=1): 0.960 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 0.977 (0.0333); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 0.980 (0.0200); Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=8): 0.973 (0.0191).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Mean, ug/mL (Standard Deviation). Cycle 1: Alomfilimab 0.8 mg (n=4): 0.3022 (0.12476); Alomfilimab 2.4 mg (n=5): 0.9773 (0.29919); Alomfilimab 8 mg (n=9): 3.3327 (0.95752); Alomfilimab 24 mg (n=7): 8.7301 (2.84671); Alomfilimab 80 mg (n=7): 33.7844 (12.98646); Alomfilimab 240 mg (n=5): 124.4294 (79.79754); Alomfilimab 0.8 mg + Atezolizumab (n=5): 0.3339 (0.17905); Alomfilimab 2.4 mg + Atezolizumab (n=35): 1.1201 (0.66885); Alomfilimab 8 mg + Atezolizumab (n=29): 3.3476 (1.23416); Alomfilimab 24 mg + Atezolizumab (n=8): 8.2597 (2.75396); Alomfilimab 80 mg + Atezolizumab (n=9): 31.4793 (10.38008). Cycle 3: Alomfilimab 0.8 mg (n=4): 0.2671 (0.06805); Alomfilimab 2.4 mg (n=5): 1.2029 (0.24583); Alomfilimab 8 mg (n=9): 3.7461 (0.86853); Alomfilimab 24 mg (n=7): 30.5647 (39.72256); Alomfilimab 80 mg (n=7): 43.8045 (14.07259); Alomfilimab 240 mg (n=5): 141.8131 (62.54794); Alomfilimab 0.8 mg + Atezolizumab (n=5): 0.2840 (0.24914); Alomfilimab 2.4 mg + Atezolizumab (n=35): 1.6449 (3.01380); Alomfilimab 8 mg + Atezolizumab (n=29): 9.5099 (28.23379); Alomfilimab 24 mg + Atezolizumab (n=8): 10.2883 (3.86029); Alomfilimab 80 mg + Atezolizumab (n=9): 51.6622 (41.65071).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Mean, hours (Standard Deviation). Cycle 1: Alomfilimab 0.8 mg (n=4): 42.7633 (20.84762); Alomfilimab 2.4 mg (n=5): 72.2276 (9.56084); Alomfilimab 8 mg (n=9): 149.0872 (55.14152); Alomfilimab 24 mg (n=8): 226.2922 (75.20291); Alomfilimab 80 mg (n=7): 377.5444 (126.28273); Alomfilimab 240 mg (n=5): 356.4297 (109.96450); Alomfilimab 0.8 mg + Atezolizumab (n=4): 37.4777 (3.96733); Alomfilimab 2.4 mg + Atezolizumab (n=36): 93.0339 (33.82676); Alomfilimab 8 mg + Atezolizumab (n=30): 165.8783 (89.07566); Alomfilimab 24 mg + Atezolizumab (n=8): 174.9685 (79.39134); Alomfilimab 80 mg + Atezolizumab (n=9): 300.0089 (113.49910). Cycle 3: Alomfilimab 2.4 mg (n=5): 80.3268 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 8 mg (n=9): 215.6472 (98.90118); Alomfilimab 24 mg (n=8): 358.6064 (143.16181); Alomfilimab 80 mg (n=7): 342.6067 (193.81667); Alomfilimab 240 mg (n=5): 273.6673 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 2.4 mg + Atezolizumab (n=36): 116.0599 (42.16269); Alomfilimab 8 mg + Atezolizumab (n=30): 202.0099 (78.48781); Alomfilimab 24 mg + Atezolizumab (n=8): 230.5514 (103.13822); Alomfilimab 80 mg + Atezolizumab (n=9): 440.0235 (236.99886).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Count Of Participants, Participants. ≥ 1 Positive Anti-alomfilimab Antibodies Result: Alomfilimab 0.8 mg (n=4): 1; Alomfilimab 2.4 mg (n=3): 0; Alomfilimab 8 mg (n=8): 2; Alomfilimab 24 mg (n=8): 1; Alomfilimab 80 mg (n=7): 1; Alomfilimab 240 mg (n=5): 0; Alomfilimab 0.8 mg + Atezolizumab (n=5): 2; Alomfilimab 2.4 mg + Atezolizumab (n=36): 9; Alomfilimab 8 mg + Atezolizumab (n=34): 8; Alomfilimab 24 mg + Atezolizumab (n=8): 0; Alomfilimab 80 mg + Atezolizumab (n=6): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=13): 1; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=11): 2; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=6): 1; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=12): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 3; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 1; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 1. ≥ 1 Positive Anti-atezolizumab Antibodies Result: Alomfilimab 0.8 mg + Atezolizumab (n=5): 1; Alomfilimab 2.4 mg + Atezolizumab (n=36): 8; Alomfilimab 8 mg + Atezolizumab (n=34): 8; Alomfilimab 24 mg + Atezolizumab (n=8): 4; Alomfilimab 80 mg + Atezolizumab (n=6): 1; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=13): 5; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=11): 2; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=6): 1; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=12): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=5): 1; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=3): 0; Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=6): 0; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): 1; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=7): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Mean, cells per mm^2 (Standard Deviation). FOXP3-ICOS double-positive cells per mm^2 in the tumor: Alomfilimab 0.8 mg (n=2): 0.275 (5.5649); Alomfilimab 2.4 mg (n=3): 21.905 (30.1015); Alomfilimab 8 mg (n=7): -50.323 (42.9514); Alomfilimab 24 mg (n=3): -42.210 (26.6714); Alomfilimab 80 mg (n=5): -29.318 (28.0896); Alomfilimab 240 mg (n=3): -67.160 (59.7524); Alomfilimab 0.8 mg + Atezolizumab (n=3): -18.860 (33.2369); Alomfilimab 2.4 mg + Atezolizumab (n=16): -129.334 (118.3340); Alomfilimab 8 mg + Atezolizumab (n=16): -90.589 (115.9495); Alomfilimab 24 mg + Atezolizumab (n=3): -117.610 (174.4591); Alomfilimab 80 mg + Atezolizumab (n=3): -3.653 (6.5269); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=8): -58.865 (65.7823); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=5): -45.618 (34.5880); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=4): -51.293 (56.8048); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=8): -76.331 (63.0946); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=1): -437.660 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC (n=2): -518.975 (668.5624); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer (n=1): -31.120 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC (n=2): -149.445 (137.0019); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=1): -197.940 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC (n=3): -397.437 (307.3676). CD8-positive cells per mm^2 in the tumor: Alomfilimab 0.8 mg (n=2): -449.920 (NA) [Standard deviation could not be calculated as a single participant was analyzed.]; Alomfilimab 2.4 mg (n=3): 448.833 (443.5399); Alomfilimab 8 mg (n=7): 47.126 (294.7947); Alomfilimab 24 mg (n=3): -105.110 (190.2826); Alomfilimab 80 mg (n=5): -11.532 (169.8503); Alomfilimab 240 mg (n=3): -371.857 (884.7449); Alomfilimab 0.8 mg + Atezolizumab (n=3): -218.017 (282.9603); Alomfilimab 2.4 mg + Atezolizumab (n=16): 111.154 (939.3540); Alomfilimab 8 mg + Atezolizumab (n=16): 174.339 (693.8745); Alomfilimab 24 mg + Atezolizumab (n=3): 300.433 (325.6656); Alomfilimab 80 mg + Atezolizumab (n=3): 21.925 (56.3211); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=8): 202.501 (588.9525); Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer (n=5): -63.528 (65.5904); Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC (n=4): 318.470 (385.7782); Al