Phase III trial of Keytruda meets primary endpoint in resected high-risk melanoma.

Merck Inc announced that the phase III EORTC1325/KEYNOTE-054 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for surgically resected high-risk melanoma, met the primary endpoint of recurrence-free survival (RFS). Based on an interim analysis and following review by the Independent Data Monitoring Committee, post-resection adjuvant therapy with Keytruda resulted in significantly longer recurrence-free survival than placebo (HR=0.57; 98.4% CI, 0.43-0.74; p<0.0001).

The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies involving patients with advanced melanoma. In accordance with the trial protocol, the study will continue in order to evaluate other key endpoints, including overall survival. Results from EORTC1325/KEYNOTE-054 will be presented at an upcoming medical meeting, and submitted to regulatory authorities.