ESALF - Merck/Eisai's Keytruda + Lenvima meets endpoints in late-stage kidney disease study

Merck (MRK) and Eisai (ESALF) announce new investigational data demonstrating positive top-line results from the Phase 3 KEYNOTE-581/CLEAR trial (Study 307).In the trial, the combinations of Merck's Keytruda plus Eisai's Lenvima and Lenvima plus everolimus were evaluated versus Sunitinib for the first-line treatment of patients with advanced renal cell carcinoma ((RCC)). The study enrolled approx. 1,050 patients.Keytruda plus Lenvima met the trial’s primary endpoint of progression-free survival ((PFS)) and its key secondary endpoints of overall survival ((OS)) and objective response rate ((ORR)), demonstrating a statistically significant and clinically meaningful improvement versus Sunitinib in the intention-to-treat ((ITT)) study population.Lenvima + everolimus also showed statistically significant improvement in PFS and ORR endpoints versus Sunitinib.The safety profiles of both the combinations were consistent with previously reported studies.Merck and Eisai will discuss these data with regulatory authorities worldwide, and submit marketing authorization applications based on these results, which will be presented at an upcoming medical meeting.

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Merck/Eisai's Keytruda + Lenvima meets endpoints in late-stage kidney disease study