Opinion Granted Based on Positive Results From Phase 3 KEYNOTE-826 Trial
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab (the KEYTRUDA regimen), for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).
The recommendation is based on results from the Phase 3 KEYNOTE-826 trial, in which the KEYTRUDA regimen demonstrated a statistically significant improvement in overall survival (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (HR=0.62 [95% CI, 0.50-0.77]; p