Eli Lilly (NYSE:LLY) announces that a Phase 3 clinical trial, MONARCH 2, assessing abemaciclib in patients with relapsed/refractory HR+/HER2- breast cancer met its primary endpoint. Participants treated with abemaciclib and fulvestrant (AstraZeneca's Faslodex) showed a statistically significant improvement in progression-free survival (PFS) compared to those receiving placebo and fulvestrant.
Detailed results will be presented at an upcoming medical conference.
The company plans to submit a marketing application in the U.S. next quarter for single-agent abemaciclib (based on data from MONARCH 1) for the treatment of patients with refractory metastatic breast cancer whose disease has progressed following multiple prior lines of therapy, including endocrine therapy and one to two chemo regimens in the metastatic setting. It expects to file an additional application for MONARCH 2 in Q3.
Shares are up a fraction premarket.