Merck Phase III Trial of Anti-PD-1 Drug (Keytruda) Meets Co-Primary Endpoints As First-Line Treatment for Advanced Melanoma and Trial Will Be Stopped Early; Keytruda Found Superior to Ipilimumab

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced on March 24, 2015 that the randomized, pivotal Phase 3 study (KEYNOTE-006) investigating KEYTRUDA® (pembrolizumab) compared to ipilimumab in the first-line treatment of patients with advanced melanoma has met its two primary endpoints of progression-free survival and overall survival. The trial will be stopped early based on the recommendation of the study’s independent Data Monitoring Committee. In the KEYNOTE-006 trial, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival compared to ipilimumab. The safety profile of KEYTRUDA in this trial was similar to the safety profile previously reported in advanced melanoma. KEYTRUDA is the first anti-PD-1 therapy to demonstrate a survival advantage compared to the standard of care for the first-line treatment of advanced melanoma. These data will be presented in the opening plenary session at the American Association of Cancer Research (AACR) Annual Meeting in Philadelphia, Pennsylvania, April 18-22, 2015. "Evidence from our clinical program for KEYTRUDA will help to define the appropriate treatment of advanced melanoma," said Dr. Roger Perlmutter, President, Merck Research Laboratories. "We greatly appreciate the efforts of our investigators and their patients in this important study, and we look forward to the presentation of overall survival data from KEYNOTE-006 at the AACR annual meeting." KEYNOTE-006 was a global, open-label, randomized, pivotal, Phase 3 study (, NCT01866319) evaluating KEYTRUDA compared to ipilimumab in patients with unresectable stage III or IV advanced melanoma with no more than one prior systemic therapy.
Login Or Register To Read Full Story