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# Data Not Strong Enough to Stop Abemaciclib Breast Cancer Trial: Lilly
- URL: https://www.fdaweb.com/data-not-strong-enough-to-stop-abemaciclib-breast-cancer-trial-lilly/
- Published: 2016-08-10T12:00:00.000Z
- Updated: 2026-09-14T21:23:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136463

Eli Lilly says that after a pre-planned interim analysis of its MONARCH 2 study involving abemaciclib, an independent Data Monitoring Committee recommended to continue the study without modification because the interim efficacy criteria were not met. The study compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. The company says final results are expected in the first half of 2017, and they will evaluate progression-free survival, overall survival and safety data.

“Lilly will await further data and continue to work with the FDA to inform its submission plan for single-agent abemaciclib, based on the MONARCH 1 study,” the company says. “This Phase 2 study evaluated the single-agent activity and safety of abemaciclib in patients with refractory metastatic breast cancer, whose disease had progressed following multiple prior treatments, including chemotherapy.”

Lilly currently has three additional MONARCH trials evaluating abemaciclib in breast cancer. MONARCH 3 is a Phase 3 trial of abemaciclib in combination with a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer. Additionally, there are two Phase 2 MONARCH trials: neoMONARCH, which is evaluating abemaciclib in combination with a nonsteroidal aromatase inhibitor in the neoadjuvant setting, and monarcHER, which is evaluating abemaciclib plus trastuzumab (with or without fulvestrant) in women with HR+, HER2+ locally advanced or metastatic breast cancer.

FDA granted the drug a breakthrough therapy designation in 2015 based on data from the breast cancer cohort expansion of a Phase 1 trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer.