Breast Cancer Coverage from Every Angle

ESMO 2019: Improved Overall Survival With Abemaciclib/Fulvestrant in Advanced Breast Cancer

By: Hillary Ojeda
Posted: Friday, October 4, 2019

According to results from the phase III MONARCH 2 trial by George W. Sledge, MD, of the Stanford University School of Medicine, and colleagues, overall survival was significantly improved in pre-, peri-, and postmenopausal women with hormone receptor–positive HER2-negative advanced breast cancer with the combination of the CDK4/6 inhibitor abemaciclib plus fulvestrant compared with placebo. The results were presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona (Abstract LBA6_PR).

“The main take-home message from this study—and from other similar studies—is that CDK4/6 inhibitors significantly prolong the time patients remain in remission and significantly improve overall survival,” concluded Dr. Sledge in an ESMO press release.

For the global, double-blind study, a total of 669 patients (pre-, peri-, or postmenopausal) were randomly selected for one of two treatments: abemaciclib plus fulvestrant or placebo plus fulvestrant. All of the women had advanced hormone receptor–positive, HER2-negative breast cancer that was resistant to endocrine therapy. They were given 150 mg of abemaciclib or placebo every 12 hours and 500 mg of fulvestrant per label.

The median overall survival was 46.7 months with abemaciclib plus fulvestrant and 37.3 months with placebo plus fulvestrant. A total of 338 deaths were recorded in the intention-to-treat group at the time of the prespecified interim analysis. “Progression-free survival 2 (hazard ratio = 0.675) and the time to chemotherapy (hazard ratio = 0.622) were also significantly improved,” the investigators reported. “Safety data were consistent with the known abemaciclib safety profile.”

Disclosure: The study authors’ disclosure information can be found at

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