Breast Cancer Drug Fails to Meet Interim Criteria

An interim analysis of Eli Lilly and Company’s breast cancer drug, abemaciclib, did not meet efficacy criteria, but the phase 3 study, MONARCH 2, was recommended to continue without modification.

MONARCH 2 compares abemaciclib plus fulvestrant with placebo plus fulvestrant in 669 women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER-2) locally advanced or metastatic breast cancer, according to a press release. Patients enrolled in the study had disease progression within 1 year of endocrine treatment.

The primary endpoint for the study was progression-free survival (PFS). Since the trial did not meet interim analysis criteria, it will continue as planned, and will include a finalized analysis of PFS.

They plan to wait for additional data, and work with the FDA to inform its submission plan for abemaciclib monotherapy, which was based on the MONARCH 1 clinical trial. MONARCH 1 analyzed the efficacy of the drug in patients with refractory metastatic breast cancer who progressed despite treatments.

“We had stringent criteria set for this interim analysis and we look forward to receiving the final MONARCH 2 results in the first half of 2017,” said Richard Gaynor, MD, senior vice president, product development and medical affairs for Lilly Oncology. “We remain optimistic that treatment with abemaciclib, in combination with fulvestrant could offer improved outcomes for patients.”