Abemaciclib: Additional Ph III MONARCH 2 data

Additional data from the double-blind, placebo-controlled, international Phase III MONARCH 2 trial in 669 postmenopausal women with hormone receptor-positive, HER2-negative breast cancer showed that twice-daily 150 mg oral abemaciclib plus Faslodex fulvestrant met the primary endpoint of improving PFS vs. Faslodex alone. The trial enrolled patients who had disease progression on or within 12 months of receiving endocrine treatment in the neoadjuvant or adjuvant setting or while receiving first-line endocrine therapy for metastatic disease. Last August, Eli Lilly said it would continue MONARCH 2 despite efficacy criteria not being met in a preplanned interim analysis (see BioCentury, Aug. 15, 2016)...