Objective. Retifanlimab is a humanized immunoglobulin G4 monoclonal antibody against programmed death 1 being investigated in several solid tumor types. We report final results from patients with recurrent microsatellite instability -high (MSI-H)/mismatch repair de ficient (dMMR) endometrial cancer treated with retifanlimab in a POD1UM-101 expansion cohort. Methods. Eligible patients ( >= 18 years; histologically proven/unresectable/recurrent, MSI-H/dMMR endometrial cancer; checkpoint inhibitor naive) received retifanlimab 500 mg intravenously every 4 weeks for <= 2 years. Primary endpoint was safety/tolerability. Results. At data cutoff (May 17, 2023), 76 patients had received at least one retifanlimab dose. Median (range) age was 67 (49-88) years; 88.2% of patients had recurrent metastatic disease and 80.3% had visceral metastases. Seventy- five patients (98.7%) had received at least one prior systemic therapy. Median retifanlimab exposure was 10.0 (0.03-25.9) months; 23 patients completed treatment. 38 patients (50.0%) had grade >= 3 treatmentemergent adverse events (TEAEs), most commonly anemia ( n = 10 [13.2%]). 63 patients (82.9%) had treatment -related AEs (TRAEs; grade >= 3, n = 14 [18.4%]); most common was fatigue ( n = 14 [18.4%]). Two patients had TEAEs that led to death; no TRAEs were fatal. 39 patients had objective responses (51.3%; 95% CI, 39.6 -63.0%); 19 patients (25.0%) had complete response and 20 (26.3%) had partial response. Median progressionfree survival was 12.2 months; 30 patients (76.9%) had duration of response (DOR) >= 12 months. Median DOR was not reached after median follow-up time of 26.0 months. Conclusions. Retifanlimab was generally well tolerated and demonstrated encouraging anti -tumor activity in patients with pre-treated recurrent MSI-H/dMMR endometrial cancer. (c) 2024 Published by Elsevier Inc.
Antitumor activity and safety of the PD-1 inhibitor retifanlimab in patients with recurrent microsatellite instability-high or deficient mismatch repair endometrial cancer: Final safety and efficacy results from cohort H of the POD1UM-101 phase I study
Lorusso, Domenica;
2024-01-01
Abstract
Objective. Retifanlimab is a humanized immunoglobulin G4 monoclonal antibody against programmed death 1 being investigated in several solid tumor types. We report final results from patients with recurrent microsatellite instability -high (MSI-H)/mismatch repair de ficient (dMMR) endometrial cancer treated with retifanlimab in a POD1UM-101 expansion cohort. Methods. Eligible patients ( >= 18 years; histologically proven/unresectable/recurrent, MSI-H/dMMR endometrial cancer; checkpoint inhibitor naive) received retifanlimab 500 mg intravenously every 4 weeks for <= 2 years. Primary endpoint was safety/tolerability. Results. At data cutoff (May 17, 2023), 76 patients had received at least one retifanlimab dose. Median (range) age was 67 (49-88) years; 88.2% of patients had recurrent metastatic disease and 80.3% had visceral metastases. Seventy- five patients (98.7%) had received at least one prior systemic therapy. Median retifanlimab exposure was 10.0 (0.03-25.9) months; 23 patients completed treatment. 38 patients (50.0%) had grade >= 3 treatmentemergent adverse events (TEAEs), most commonly anemia ( n = 10 [13.2%]). 63 patients (82.9%) had treatment -related AEs (TRAEs; grade >= 3, n = 14 [18.4%]); most common was fatigue ( n = 14 [18.4%]). Two patients had TEAEs that led to death; no TRAEs were fatal. 39 patients had objective responses (51.3%; 95% CI, 39.6 -63.0%); 19 patients (25.0%) had complete response and 20 (26.3%) had partial response. Median progressionfree survival was 12.2 months; 30 patients (76.9%) had duration of response (DOR) >= 12 months. Median DOR was not reached after median follow-up time of 26.0 months. Conclusions. Retifanlimab was generally well tolerated and demonstrated encouraging anti -tumor activity in patients with pre-treated recurrent MSI-H/dMMR endometrial cancer. (c) 2024 Published by Elsevier Inc.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
