Core Insights - Eli Lilly and Company announced positive topline results from the Phase 3 monarchE trial, showing that treatment with Verzenio plus endocrine therapy significantly improves overall survival in high-risk early breast cancer patients compared to endocrine therapy alone [1][3][5] Summary by Sections Overall Survival and Efficacy - The seven-year landmark analysis of the monarchE trial demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) with Verzenio plus endocrine therapy [1][2] - Verzenio treatment also resulted in sustained benefits in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), indicating the durability of the treatment effect [2] Treatment Standardization - The results reinforce the use of two years of Verzenio plus endocrine therapy as the standard of care for patients with hormone receptor positive (HR+), HER2-negative, node-positive, early breast cancer at high risk of recurrence [1][3] Study Design and Population - The monarchE study enrolled 5,637 adults across more than 600 sites in 38 countries, specifically targeting high-risk early breast cancer patients [5] - Patients were randomized to receive either Verzenio plus standard-of-care endocrine therapy or endocrine therapy alone for two years, with the primary endpoint being IDFS [5] Safety Profile - The overall safety profile of Verzenio remained consistent with previous reports, with no new safety concerns identified after all patients completed or discontinued the two-year treatment [3][4] Future Directions - Detailed results from the trial will be presented at future medical meetings and submitted for publication in peer-reviewed journals [4]