Long term efficacy data for Keytruda from Phase III KEYNOTE 006 and Phase I KEYNOTE 001 studies in advanced melanoma.- Merck Inc.

Merck has announced long-term efficacy data from the Phase III KEYNOTE-006 study and the melanoma cohort of the Phase 1b KEYNOTE-001 study investigating Keytruda, Merck’s anti-PD-1 therapy, in patients with advanced melanoma. A new analysis from KEYNOTE-006 demonstrated durable efficacy benefits among patients who completed two years of Keytruda treatment, combined with updated overall survival (OS) results across both studies, confirming anti-tumor activity in advanced melanoma patients. At a median follow-up of 20.3 months after completion of Keytruda in KEYNOTE-006, 86 percent of patients remained progression-free, the co-primary endpoint for the study.

For the primary endpoint of OS in KEYNOTE-006, the four-year OS rate was 41.7 percent in the pooled Keytruda arms vs. 34.1 percent in the ipilimumab arm; in treatment-naïve patients, OS rates were 44.3 percent in the pooled Keytruda arms and 36.4 percent in the ipilimumab arm. In KEYNOTE-001, the five-year OS rate, a secondary endpoint for the study, was 34 percent in all patients and 41 percent in treatment-naïve patients.

The safety profile of Keytruda in both studies was consistent with what has been seen in previous trials among patients with advanced melanoma. Results for KEYNOTE-006 (Abstract #9503) and KEYNOTE-001 (Abstract #9516) are being presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.