Merck: KEYTRUDA Found Superior To Ipilimumab In Advanced Melanoma Phase 3 Study

(RTTNews) - Merck (MRK) announced results from the randomized, pivotal Phase 3 study, KEYNOTE-006, in the treatment of unresectable advanced melanoma. In the study, KEYTRUDA (pembrolizumab) was statistically superior to ipilimumab for progression-free survival, overall survival, and overall response rate.

Roger Perlmutter, president, Merck Research Laboratories. "The KEYNOTE-006 study compared two immunotherapies that target distinct immune checkpoint pathways, PD-1 and CTLA-4. In this study, our anti-PD-1 antibody, KEYTRUDA, improved overall survival by more than 30 percent compared to ipilimumab, an anti-CTLA-4 antibody, in the treatment of advanced melanoma. We look forward to filing these data with the FDA and health authorities around the world."

On March 24, Merck announced that KEYNOTE-006 would be stopped early based on the data. In mid-2015, Merck plans to submit a supplemental Biologics License Application (sBLA) for KEYTRUDA based on KEYNOTE-006 for the first-line treatment of advanced melanoma.