Abemaciclib in Breast Cancer Treatment
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- April 26, 2017
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Eli Lilly and Company announced significant findings regarding its investigational agent, Abemaciclib, for the treatment of HER2-negative advanced breast cancer. An interim analysis of the Phase 3 MONARCH 3 study demonstrated that the combination of Abemaciclib (a CDK4/6 inhibitor) with an aromatase inhibitor (CYP19 inhibitor) significantly prolonged progression-free survival (PFS) compared to aromatase inhibitor monotherapy.
The MONARCH 3 trial reached its primary endpoint of improved PFS. Additionally, the results showed improvements in objective response rates (ORR) in the combination arm. Detailed findings from this clinical trial are expected to be presented later this year.
MONARCH 3 is a global, double-blind, placebo-controlled Phase 3 clinical trial enrolling 493 postmenopausal women with HER2-negative advanced or metastatic breast cancer who have not received prior systemic therapy for their advanced disease. The study evaluates the efficacy and safety of Abemaciclib (150 mg twice daily) in combination with either Anastrozole (1 mg daily) or Letrozole (2.5 mg daily), compared to an aromatase inhibitor plus placebo.
The secondary endpoints include overall response rate, overall survival, and safety. Consistent with previous clinical evaluations of Abemaciclib, the most frequently reported adverse events include diarrhea, fatigue, nausea, and neutropenia.
Source: Eli Lilly and Company Investor Relations News.
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