Merck says Phase 3 KEYLYNK-001 trial met primary endpoint

Merck (MRK) announced that the Phase 3 KEYLYNK-001 trial evaluating KEYTRUDA plus chemotherapy followed by maintenance with LYNPARZA, with or without bevacizumab, as a first-line treatment for people with BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of progression-free survival. At the final analysis conducted by an independent Data Monitoring Committee, the KEYTRUDA plus LYNPARZA regimen demonstrated a statistically significant and clinically meaningful improvement in PFS for these patients compared to chemotherapy alone. The study did not reach its secondary endpoint of overall survival. The role of KEYTRUDA in the intention-to-treat population remains uncertain at this time. The safety profiles of KEYTRUDA and LYNPARZA were consistent with those observed in previously reported studies for the individual therapies. These results will be presented at an upcoming medical meeting and discussed with regulatory authorities.