Eli Lilly’s phase 3 double-blind study (MONARCH 2) designed to evaluate the efficacy and safety of abemaciclib, in combination with fulvestrant, in patients with advanced (locoregionally recurrent or metastatic) breast cancer has met its primary endpoint.
Lilly explained that the trial evaluated abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy.
“These data are an important milestone in our goal of bringing abemaciclib to patients with advanced breast cancer.” said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology.
Lilly said that it intends to submit a new drug application (NDA) for single-agent abemaciclib in the second quarter of 2017, based on the MONARCH 1 study, for the treatment of refractory metastatic breast cancer patients whose disease had progressed following multiple prior treatments, including endocrine therapy and one to two chemotherapy regimens in the metastatic setting. Also, the company plans to submit an additional application for MONARCH 2 in the third quarter of this year.
Along with MONARCH 1 and MONARCH 2, Lilly noted that it currently has additional trials evaluating abemaciclib in breast cancer. The company explined that MONARCH 3 is a Phase 3 trial of abemaciclib in combination with a nonsteroidal aromatase inhibitor in patients with HR+, HER2- advanced breast cancer. Additionally, there is a Phase 2 MONARCH trial under way: monarcHER, which is evaluating abemaciclib plus trastuzumab (with or without fulvestrant) in women with HR+, HER2+ locally advanced or metastatic breast cancer, the company said.