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CDK4/6 Inhibitor Shows Promise as Single Agent in HR+ Breast Cancer

Greg Kennelty
Published: Wednesday, Jul 06, 2016

Maura Dickler, MD

Maura Dickler, MD

As a single agent, abemaciclib has shown exciting potential in heavily pretreated patients with refractory, hormone-receptor (HR)–positive, HER2-negative advanced breast cancer, following phase II findings of the MONARCH 1 trial. 

, Dickler, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses findings from the recent phase II study exploring abemaciclib as a single agent in patients with HR-positive breast cancer, along with an upcoming phase III trial looking at combination strategies. Dickler also discusses the PI3K-alpha inhibitor taselisib, which was examined in combination with fulvestrant in a phase II study.

OncLive: Can you tell us about the MONARCH1 trial?

Dickler: MONARCH 1 was a straight phase II study of single-agent abemaciclib, a CDK4 and CDK6 inhibitor, in previously treated women with hormone receptor (HR)-positive metastatic breast cancer. It was a multicenter trial. The study enrolled 132 women who had previously received endocrine therapy and also at least one, but not more than two, chemotherapies for metastatic disease. It was a group of women where we typically wouldn't offer additional endocrine therapy, and that their typical next treatment would be chemotherapy. We know in that setting, response rates for chemotherapy are in the order of 10% to 20% with progression-free survival (PFS) of about 3 to 4 months.
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