ASCO 2022 | MAINTAIN: fulvestrant or exemestane +/- ribociclib after anti-estrogen therapy + CDK4/6i in HR+ MBC
CDK4/6 inhibition has previously shown significant benefit in progression-free survival (PFS) in patients with HR-positive, HER2-negaitve metastatic breast cancer (mBC). Switching anti-estrogen therapies following disease progression is the standard of care (SOC) for this patient population. Kevin Kalinsky, MD, MS, Winship Cancer Institute of Emory University, Atlanta, GA, talks on the randomized, multicentered, double-blind, placebo-controlled Phase II MAINTAIN (NCT02632045) trial investigating fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition in patients with unresectable or HR-positive, HER2-negative metastatic breast cancer (mBC). This interview took place at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting in Chicago, IL.
Transcript (edited for clarity)
So the MAINTAIN trial was a randomized study, which was looking to address the question of whether there’s benefit of CDK4/6 inhibitor after a patient has had a tumor that’s already progressed on a CDK4/6 inhibitor. So the design of the study, patients could have had any endocrine therapy or any CDK4/6 inhibitor, and then were randomized to switching the endocrine therapy with or without the CDK4/6 inhibitor ribociclib...
So the MAINTAIN trial was a randomized study, which was looking to address the question of whether there’s benefit of CDK4/6 inhibitor after a patient has had a tumor that’s already progressed on a CDK4/6 inhibitor. So the design of the study, patients could have had any endocrine therapy or any CDK4/6 inhibitor, and then were randomized to switching the endocrine therapy with or without the CDK4/6 inhibitor ribociclib. And it was a placebo control trial. Primary endpoint was looking at progression free survival, and we saw a statistically significant improvement in the patients who were randomized to ribociclib as opposed to placebo, with a hazard ratio that was a little less than 0.6.
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