Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer

This phase 3 trial evaluated dostarlimab (an anti-PD-1 immune checkpoint inhibitor) combined with carboplatin paclitaxel versus placebo plus chemotherapy in patients with primary advanced or recurrent endometrial cancer. Among 494 randomized patients, dostarlimab significantly improved progression free survival (PFS) at 24 months in both the mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) population (61.4% vs. 15.7%; hazard ratio [HR] 0.28, P<0.001) and the overall population (36.1% vs. 18.1%; HR 0.64, P<0.001). Overall survival (OS) at 24 months was 71.3% with dostarlimab versus 56.0% with placebo (HR 0.64). Adverse events (e.g., nausea, fatigue) were more frequent with dostarlimab. The combination demonstrated clinically meaningful efficacy, particularly in dMMR–MSI-H tumors.

This phase 3 trial evaluated dostarlimab (an anti-PD-1 immune checkpoint inhibitor) combined with carboplatin paclitaxel versus placebo plus chemotherapy in patients with primary advanced or recurrent endometrial cancer. Among 494 randomized patients, dostarlimab significantly improved progression free survival (PFS) at 24 months in both the mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) population (61.4% vs. 15.7%; hazard ratio [HR] 0.28, P<0.001) and the overall population (36.1% vs. 18.1%; HR 0.64, P<0.001). Overall survival (OS) at 24 months was 71.3% with dostarlimab versus 56.0% with placebo (HR 0.64). Adverse events (e.g., nausea, fatigue) were more frequent with dostarlimab. The combination demonstrated clinically meaningful efficacy, particularly in dMMR–MSI-H tumors.