Pembrolizumab (Keytruda, Merck) significantly improved recurrence-free survival compared with placebo in a phase 3 trial investigating the anti-PD-1 medication as monotherapy for surgically resected high-risk melanoma.
Based on an interim analysis and following review by an Independent Data Monitoring Committee, post-resection adjuvant therapy with pembrolizumab resulted in significantly longer recurrence-free survival than placebo (hazard ratio, 0.57; 98.4% confidence interval, 0.430.74; P < 0.0001). The safety profile of pembrolizumab was consistent with that observed in previously reported studies involving patients with advanced melanoma.
Merck and the European Organisation for Research and Treatment of Cancer (EORTC), announced the results from this phase 3 study, the EORTC1325/KEYNOTE-054 trial. 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 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.
KEYNOTE-054 is a randomized, double-blind study sponsored by Merck and conducted in collaboration with EORTC. In total, the study enrolled 1,019 patients who were randomly assigned to receive either pembrolizumab at a flat dose of 200 mg intravenously (IV) on day 1 of each 21-day cycle for up to one year or placebo IV on day 1 of each 21-day cycle for up to one year. This represents a total of 18 outpatient administrations. The primary endpoint is RFS for all patients and RFS in patients whose tumors express PD-L1; secondary endpoints include distant metastases-free survival and overall survival in all patients and in patients whose tumors express PD-L1.
Source: Merck; January 8, 2018.