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ARTICLE | Clinical News

Lilly reports detailed MONARCH 2 data of abemaciclib in breast cancer

June 9, 2017 3:09 AM UTC

Eli Lilly and Co. (NYSE:LLY) reported additional data from Phase III MONARCH 2 trial in 669 postmenopausal women with hormone receptor-positive, HER2-negative breast cancer showing that twice-daily 150 mg oral abemaciclib (LY2835219) plus Faslodex fulvestrant led to a median progression-free survival (PFS), the primary endpoint, of 16.4 months vs. 9.3 months for Faslodex alone (HR=0.553, 95% CI: 0.449, 0.681, p<0.0000001). In patients with measurable disease, abemaciclib plus Faslodex led to an objective response rate (ORR) and complete response rate of 48.1% and 3.5%, respectively, vs. 21.3% and 0% for Faslodex alone. Data were presented at the American Society of Clinical Oncology meeting in Chicago and published in the Journal of Clinical Oncology.

The double-blind, placebo-controlled, international 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. Secondary endpoints include overall survival (OS), ORR, duration of response, disease control rate (DCR), clinical benefit rate (CBR), pain and symptom burden per the Brief Pain Inventory (BPI), pharmacokinetics and quality of life (QOL)...