Phase III trial of Keytruda (pembrolizumab) meets primary endpoints in Advanced Melanoma and stops early-Merck

Merck has announced that the randomized, pivotal Phase III 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 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 plenary session at the American Association of Cancer Research Annual Meeting.

Comment: The first cancer drug in the US to block the PD-1 pathway, Keytruda is intended for use following treatment with Yervoy (ipilimumab), while for melanoma patients whose tumours express the BRAF V600 gene mutation, Keytruda can be used after Yervoy and a BRAF inhibitor, like Zelboraf (vemurafenib) and Tafinlar (dabrafenib).