Results from study of KEYTRUDA versus ipilimumab in advanced melanoma announced

Results from the randomised, pivotal Phase 3 study, KEYNOTE-006, in the treatment of unresectable advanced melanoma demonstrate Merck’s KEYTRUDA® (pembrolizumab) was statistically superior to ipilimumab for progression-free survival (PFS), overall survival (OS), and overall response rate (ORR).

On 24 March 2015, Merck announced that KEYNOTE-006 would be stopped early based on these data.The results were presented at the American Association for Cancer Research (AACR) Annual Meeting and have been published in the New England Journal of Medicine.

KEYTRUDA demonstrated a lower frequency of severe adverse events to ipilimumab

“Improving survival is the ultimate objective in treating patients with cancer. In this important study in advanced melanoma, KEYTRUDA was statistically superior to ipilimumab for progression-free survival and overall survival, and also demonstrated a lower frequency of severe adverse events.” said Dr Caroline Robert, head of dermatology at Gustave Roussy, Villejuif and Paris-Sud University Cancer Campus, Grand Paris.

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. Merck recently submitted data from KEYNOTE-002 in ipilimumab-refractory advanced melanoma as part of a supplemental application. KEYTRUDA was the first anti-PD-1 therapy approved in the US and is currently indicated in the US for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

KEYTRUDA improved overall survival by more than 30 percent compared to iplimumab in the study

“Our goal with the KEYTRUDA development program is to help improve long-term disease control and survival for people suffering from a wide range of cancers,” said Dr. 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.”