Dr. Finn on the FDA Approval of Frontline Abemaciclib in HR+/HER2- Breast Cancer

Richard S. Finn, an associate professor of medicine at the Geffen School of Medicine at the University of California, Los Angeles, discusses the FDA approval of abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.

The approval was based on data from the phase III MONARCH 3 trial in which the addition of abemaciclib to anastrozole or letrozole reduced the risk of progression or death by 46% compared with the nonsteroidal aromatase inhibitor (NSAI) alone for previously untreated patients with HER2-negative, HR-positive advanced breast cancer.

In the phase III study, the median progression-free survival was 28.2 months (95% CI, 23.5 to not reached) in the abemaciclib arm versus 14.8 months (95% CI,11.2-19.2) with the NSAI alone (HR, 0.54; 95% CI, 0.418-0.698; P <.0001). In those with measurable disease, the objective response rate (ORR) was 55.4% with the CDK4/6 inhibitor and 40.2% in the control arm.