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Merck Says Phase 3 KEYTRUDA Trial Meets Primary Endpoint

Merck (MRK) Monday said its KEYTRUDA anti-PD-1 therapy for surgically resected high-risk melanoma met the primary endpoint of recurrence-free survival. The company, known as MSD outside the US, said phase 3 randomized, double-blind EORTC1325/KEYNOTE-054 trial resulted in significantly longer recurrence-free survival than placebo. The study will continue in order to evaluate other key endpoints, including overall survival.

Merck plans to present the results at an upcoming medical meeting.
In total, the study enrolled 1,019 patients who were randomly assigned to receive either KEYTRUDA at a flat dose of 200 mg intravenously on day 1 of each 21-day cycle for up to 1 year or placebo IV on day 1 of each 21-day cycle for up to 1 year.

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