Merck Says Phase 3 KEYNOTE-564 Trial Evaluating KEYTRUDA Met Primary Endpoint - Quick Facts

By RTTNews3 days ago


(RTTNews) - Merck & Co. Inc. (MRK), known as MSD outside the U.S. and Canada, announced Thursday that the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, met its primary endpoint of disease-free survival (DFS) for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following nephrectomy (surgical removal of a kidney) or following nephrectomy and resection of metastatic lesions.

Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo.

The trial will continue to evaluate overall survival (OS), a key secondary endpoint. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies.

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