Erika P. Hamilton, MD
Abemaciclib (Verzenio) monotherapy continued to be safe and effective for patients with hormone receptor (HR)–positive, HER2-negative advanced breast cancer who have progressed on or following endocrine therapy, based on findings from the phase II nextMONARCH 1 trial.
, Hamilton, director, Breast and Gynecologic Research Program, Sarah Cannon Research Institute, discussed the findings from the phase II nextMONARCH 1 study of abemaciclib in HR-positive, HER2-negative advanced breast cancer.
OncLive: What was the rationale for the study?
: The goal of this study was to take a more proactive approach compared with the precursor study, MONARCH 1. In that study, prophylactic loperamide or a prophylactic dose reduction was not looked at for diarrhea. Knowing what we know about abemaciclib now, we wanted to answer the question of whether going down to 150 mg of abemaciclib or using prophylactic loperamide once daily with 200 mg of abemaciclib would increase tolerability, decrease diarrhea, and ultimately increase compliance.
What was the rationale for studying abemaciclib specifically of the 3 CDK4/6 inhibitors?
Abemaciclib is a CDK4/6 inhibitor that we believe has single-agent activity. It's been shown in previous studies, as well as in this phase II study. We wanted to know whether adding tamoxifen and endocrine therapy to abemaciclib boosts the duration of response, or whether abemaciclib alone is sufficient as a monotherapy.
What was the design of the trial?
It was a 3-arm trial. In arm A, patients were given tamoxifen in combination with 150 mg of abemaciclib. In arm B, patients received 150 mg of abemaciclib monotherapy. In arm C, patients got 200 mg of abemaciclib monotherapy in combination with 2 mg of loperamide once daily.
What were the findings?
We discovered a number of things. First, the PFS ranged from 6.5 months to 9.1 months, though this was not statistically significant across the arms. It looked like abemaciclib monotherapy had equal activity, as far as PFS was concerned, to the combination with tamoxifen. As far as the ORR, the highest response rate was in arm C, in which abemaciclib was given at a dose of 200 mg; the ORR in that arm was 29%. In the original MONARCH 1 trial, the response rate was about 19%, so [the increased dose] did improve the response by about 10%.
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