On March 24, 2015 Merck reported 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 (Press release, Merck & Co, MAR 24, 2015, View Source [SID:1234502518]). The trial will be stopped early based on the recommendation of the study’s independent Data Monitoring Committee. In KEYNOTE-006, 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) (Free AACR Whitepaper) Annual Meeting in Philadelphia, April 18-22. Schedule your 30 min Free 1stOncology Demo! "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 (Free AACR Whitepaper) annual meeting."
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