KENILWORTH, N.J. & WOODCLIFF LAKE, N.J. - Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai announced that the U.S. Food and Drug Administration (FDA) has approved the combination of KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). The approval is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (PFS), overall survival (OS) and confirmed objective response rate (ORR).

For PFS, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 61% (HR=0.39 [95% CI: 0.32-0.49]; p

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