Merck reports Phase 3 ovarian cancer trial meets survival endpoint

Merck (MRK) announced that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its secondary endpoint of overall survival, or OS, for the treatment of patients with platinum-resistant recurrent ovarian cancer in all comers. The trial studied Keytruda – pembrolizumab -, Merck’s anti-PD-1 therapy, in combination with chemotherapy – paclitaxel – with or without bevacizumab for these patients. KEYNOTE-B96 already met its primary endpoint of progression-free survival, or PFS, in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 and in all comers, as well as its secondary endpoint of OS for patients whose tumors express PD-L1, at previous interim analyses. At the final analysis of the trial, the KEYTRUDA-based regimen demonstrated a statistically significant and clinically meaningful improvement in OS in all comers 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 from this final analysis will be presented at an upcoming medical meeting. Keytruda is not approved to treat ovarian cancer. Lynparza – olaparib -, jointly developed and commercialized by AstraZeneca (AZN) and Merck, has three approved ovarian cancer indications in the U.S..