Overall survival results of the multinational phase 3 RUBY trial of dostarlimab plus chemotherapy for advanced endometrial cancer

The multinational phase 3 RUBY trial compared six cycles of dostarlimab (anti-PD-1) plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel followed by three years dostarlimab or placebo maintenance for stage III-IV or first recurrent endometrial cancer. Overall survival data have now been published, with 51% maturity. Dostarlimab resulted in a statistically significant reduction in the risk of death (HR 0.68; p=0.0020) among all randomized patients and in the dMMR/MSI-H population (0.32; p=0.0002), while there was a trend of overall survival benefit with dostarlimab in the MMRp/MSS population (0.79; p=0.0493). There were no new safety concerns. The authors conclude that addition of dostarlimab to carboplatin-paclitaxel chemotherapy for advaced or recurrent cervical cancer was associated with improved overall survival.