Lilly's abemaciclib successful in late-stage breast cancer study

|By:, SA News Editor

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.

Breakthrough Therapy-tagged abemaciclib is a cell cycle inhibitor that is designed to block the growth of cancer cells by inhibiting the enzymes CDK4 and CDK6.

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.

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