Lilly's abemaciclib passes Phase III breast cancer test

Eli Lilly and Co. (NYSE:LLY) said abemaciclib (LY2835219) met the primary endpoint in the Phase III MONARCH 2 trial to treat advanced breast cancer in patients who have relapsed or progressed after endocrine therapy. In 3Q17, the pharma plans to submit a regulatory application to FDA based on the MONARCH 2 data.

Abemaciclib in combination with Faslodex fulvestrant significantly improved progression-free survival (PFS) compared to Faslodex alone in 669 postmenopausal women with hormone receptor-positive, HER2-negative breast cancer. Lilly said detailed data will be presented at an upcoming medical meeting. In August, the company said it would continue MONARCH 2 despite efficacy criteria not being met in a preplanned interim analysis (see BioCentury Extra, Aug. 10, 2016)...