Lilly reports additional Phase III breast cancer data for abemaciclib

Eli Lilly and Co. (NYSE:LLY) reported additional data from the Phase III MONARCH 3 trial in 493 postmenopausal women with hormone receptor-positive, HER2-negative, locoregionally recurrent or metastatic breast cancer showing that median progression-free survival, the primary endpoint, was not reached in patients receiving twice-daily 150 mg oral abemaciclib (LY2835219) plus anastrozole or letrozole vs. 14.7 months for anastrozole or letrozole alone (HR=0.54, 95% CI: 0.41, 0.72, p=0.000021). Abemaciclib plus anastrozole or letrozole led to an ORR, a secondary endpoint, of 59% vs. 44% for anastrozole or letrozole alone (p=0.04). Data were presented at the European Society for Medical Oncology meeting in Madrid.

Lilly previously reported that abemaciclib plus anastrozole or letrozole met the PFS and ORR endpoints (see BioCentury, April 27). Additional secondary endpoints in the double-blind, placebo-controlled, international trial include overall survival (OS), duration of response, disease control rate (DCR), clinical benefit rate and pharmacokinetics...