Merck says Phase 3 KEYNOTE-B96 trial met primary endpoint

Merck (MRK) announced that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers. The study also met a secondary endpoint of overall survival in patients whose tumors express PD-L1. The study is evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy with or without bevacizumab for these patients. The trial is continuing and OS for the full study population will be evaluated at a future analysis. At pre-specified interim analyses conducted by an independent Data Monitoring Committee, the KEYTRUDA-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy with or without bevacizumab. The study also showed a statistically significant and clinically meaningful improvement in OS in patients whose tumors express PD-L1 compared to placebo plus chemotherapy with or without bevacizumab. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.