Eli Lilly and Company’s Verzenio® (abemaciclib), a CDK4/6 inhibitor, has demonstrated significant improvement in overall survival (OS) in patients with hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive, high-risk early breast cancer, as reported in the phase 3 monarchE trial. This global, randomized, open-label, multicenter study enrolled 5,637 patients across 600 sites in 38 countries, evaluating two years of Verzenio plus endocrine therapy (ET) against ET alone.
The primary OS analysis, announced on August 27, 2025, showed a statistically significant and clinically meaningful OS improvement with Verzenio. The seven-year landmark analysis also confirmed sustained benefits in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), reinforcing Verzenio’s efficacy.
The trial targeted patients with high-risk features, such as 4+ positive nodes or 1-3 nodes with additional risk factors. No new safety signals were observed, consistent with prior reports. These findings validate Verzenio as a standard-of-care for this patient population, emphasizing its role in preventing disease relapse and extending survival. Detailed results will be presented at a future medical meeting and submitted for peer-reviewed publication.
This evidence highlights Verzenio’s potential to address an unmet need in high-risk early breast cancer, offering a transformative treatment option that could delay progression to advanced disease and improve patient outcomes.
