Merck (NYSE: MRK), known as MSD outside the United States and Canada, and The European Organisation for Research and Treatment of Cancer (EORTC), today announced that the phase 3 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 RFS 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.

“This has been a great collaboration between Merck and the EORTC and the findings from this interim analysis show the potential for KEYTRUDA to significantly prolong the time before the disease recurs in patients with high-risk melanoma,“ said Roger Dansey, MD, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “This result demonstrates the meaningful benefit that KEYTRUDA offers for patients with melanoma. We thank the patients, investigators, and our partners at the EORTC for their important contributions to this study.”

“This result shows a significant advancement for patients that could potentially change the way melanoma is treated in the future,” said Alexander Eggermont, study chair, Director General at the Gustave Roussy Cancer Institute, Professor of Oncology, University of Paris-Saclay.