Disappointing Phase III results with Verzenio

Given that just late last month the US Food and Drug Administration granted approval for Verzenio (abemaciclib), under the agency’s Breakthrough and Priority Review designation programs, in breast cancer, it comes as a great disappointment that the drug failed to meet its goals in lung cancer.

US pharma major Eli Lilly (NYSE: LLY), whose shares dropped as much as 3% in pre-market trading,  today announced that its Phase III JUNIPER study evaluating Verzenio, a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non-small lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS).

However, an analysis of the secondary study endpoints of both progression-free survival (PFS) and overall response rate (ORR) showed evidence of monotherapy activity in the abemaciclib arm. In addition, the control arm showed a higher overall survival rate than expected based on historical data in this setting. Lilly will submit the data for presentation at a medical meeting in 2018.