Eli Lilly’s Verzenio Improves Overall Survival In Phase 3 MonarchE Trial For Early Breast Cancer

Eli Lilly and Company reported positive topline results from the Phase 3 monarchE trial, showing that two years of Verzenio (abemaciclib) plus endocrine therapy (ET) significantly improved overall survival (OS) compared with ET alone in patients with hormone receptor-positive (HR+), HER2-negative, node-positive, high-risk early breast cancer. The seven-year landmark analysis reinforced the durability of Verzenio’s benefit, demonstrating sustained improvements in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS).

"Preventing disease relapse and helping patients live longer is the ultimate goal and a high bar in the adjuvant setting. Achieving a statistically significant OS benefit with just two years of Verzenio therapy reinforces its differentiated profile in high-risk HR+, HER2- early breast cancer. These data validate Verzenio as the standard-of-care for patients with node-positive, high-risk disease and increase the urgency to ensure all eligible patients are treated," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. 

These results highlight the long-term impact of adding Verzenio to standard endocrine therapy in this high-risk patient population. All patients have now completed or discontinued the two-year Verzenio treatment period. The safety profile of Verzenio remained unchanged and consistent with prior data, supporting its established tolerability in early breast cancer treatment.