CHICAGO – Adding ribociclib to endocrine therapy significantly improved overall survival of premenopausal women with advanced hormone receptor positive, HER2-negative breast cancer, results of the randomized phase 3 MONALEESA-7 trial showed.
A landmark analysis performed at 42 months of follow-up showed that the overall survival (OS) rate for women randomized to receive endocrine therapy with either a nonsteroidal aromatase inhibitor (AI) or tamoxifen plus the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) was 70%, compared with 46% for women randomized to endocrine therapy plus placebo.
The trial is the first study to evaluate a CDK4/6 inhibitor exclusively in premenopausal women, and the first to show a statistically significant improvement in overall survival with a CDK4/6 inhibitor in combination with endocrine therapy in patients with HR-positive, HER2-negative advanced breast cancer.
In a video interview at the American Society of Clinical Oncology annual meeting, Sara A. Hurvitz, MD, from the University of California Los Angeles Jonsson Comprehensive Cancer Center, describes the significance of the MONALEESA-7 findings and the potential for improving on the study results with other agents or combinations.
The MONALEESA-7 trial is supported by Novartis. Dr. Hurvitz reported travel and accommodation expenses from Novartis.