EU approves Keytruda for stage III melanoma and lymph node involvement after resection.- Merck Inc.

Merck Inc. announced that the European Commission has approved Keytruda (pembrolizumab) for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection. This approval is based on data from the pivotal Phase III EORTC1325/KEYNOTE-054 trial, conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). An updated recurrence-free survival (RFS) data analysis, conducted at the request of the European Medicines Agency, demonstrated that Keytruda significantly prolonged RFS, reducing the risk of disease recurrence or death by 44 percent compared to placebo in the overall population of patients with resected, high-risk stage III melanoma (HR=0.56; 98% CI, 0.44-0.72; p<0.0001). keytruda is also approved in europe as a monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults.>

The approval was based on data from the EORTC1325/KEYNOTE-054 trial, a Phase III, multicenter, randomized, double-blind, placebo-controlled study sponsored by Merck and conducted in collaboration with the EORTC. The study is evaluating adjuvant therapy with Keytruda compared to placebo in patients with completely resected melanoma (stage IIIA [more than 1 mm lymph node metastasis], IIIB or IIIC according to American Joint Committee on Cancer (AJCC) 7th edition). In total, the study enrolled 1,019 adult patients who were randomly assigned (1:1) to receive either an intravenous infusion of Keytruda 200 mg (n=514) or placebo (n=505) every three weeks for up to one year until disease recurrence or unacceptable toxicity. Co-primary endpoints were RFS for all patients and RFS in patients whose tumors express PD-L1. Recurrence-Free Survival was defined as the time from randomization until the date of first recurrence (local, regional or distant metastasis) or death, whichever occurred first.