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

• Merck (NYSE:MRK) and Eisai (OTCPK: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.
• https://seekingalpha.com/news/3634251-merck-eisais-keytruda-lenvima-meets-endpoints-in-late-stage-kidney-disease-study