(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.
KEYTRUDA is currently approved in the U.S., Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC.
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