Eli Lilly and Co. (LLY) announced Monday that its MONARCH 2 breast cancer Study trial of abemaciclib met the primary endpoint of progression-free survival. Abemaciclib, in combination with fulvestrant, was superior to fulvestrant plus placebo in patients with HR+, HER2- advanced breast cancer, the company noted.
The Phase 3 study evaluated abemaciclib, a cyclin-dependent kinase or CDK 4 and CDK 6 inhibitor, in combination with fulvestrant in women with hormone-receptor-positive or HR+, human epidermal growth factor receptor 2-negative, advanced breast cancer who have relapsed or progressed after endocrine therapy.
The results demonstrated the addition of abemaciclib to fulvestrant resulted in a statistically significant improvement in PFS, when compared to the control arm of placebo plus fulvestrant. Detailed efficacy and safety results will be presented at an upcoming medical meeting.
The global Phase 3, double-blind study was designed to evaluate the efficacy and safety of abemaciclib, in combination with fulvestrant, in patients with advanced breast cancer.
The most common adverse events observed were diarrhea, neutropenia, nausea and fatigue, and were consistent with the previous studies of abemaciclib.
Lilly intends to submit a new drug application or NDA for single-agent abemaciclib in the second quarter of 2017, based on the MONARCH 1 study.
Lilly plans to submit an additional application for MONARCH 2 in the third quarter of this year.
by RTT Staff Writer
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