MO10-6 Phase 1 study of retifanlimab (anti-PD-1) and INCB001158 (arginase inhibitor), alone or in combination, in solid tumors

Retifanlimab (INCMGA00012) is a humanized monoclonal antibody targeting programmed death protein-1 (PD-1). INCB001158 potent, highly selective arginase inhibitor that may improve anti-tumor immune responses. For patients (pts) who relapse or develop resistance to anti-PD-1 agents, combination therapy be an option. POD1UM-104 (NCT03910530) phase 1b, open-label, multicenter study evaluate safety and tolerability, determine the recommended 2 dose, assess pharmacokinetics of retifanlimab INCB001158, alone in combination, Japanese pts with advanced solid tumors. This first tolerability this treatment combination. Pts enrolled were ≥18 years confirmed metastatic tumors, relapsed refractory (r/r) disease, no further available effective standard therapy. received either single agent (Group 1, 500 mg Q4W), escalating doses 2, 75 100 BID), (500 Q4W) (100 BID) 3) for up years. As August 28, 2020, 18 1-3, n=6 each); median (range) age was 59.5 (46-75) years, 14 (77.8%) female, all had ECOG-PS ≤1 disease. At data cutoff, ongoing (both Group 1). No DLTs reported. 17 (94.4%) experienced TEAE; most common rash (3 [50.0%] each Groups 1 3). (33.3%) Grade ≥3 TEAE, pt serious there fatal events. PR (16.7%) 3 (50.0%) SD as best overall Retifanlimab, generally well tolerated r/r monotherapy showed preliminary clinical activity population.