Eli Lilly said a new analysis of its Phase 3 monarchE study found that a two-year course of Verzenio (abemaciclib) added to standard endocrine therapy significantly improved overall survival in adults with hormone-receptor positive, HER2-negative, node-positive, high-risk early breast cancer. The company described the survival gain as both statistically significant and clinically meaningful, bolstering earlier data showing the drug cut the risk of disease recurrence. The seven-year landmark analysis covered all 5,637 participants enrolled at more than 600 sites in 38 countries. Lilly reported that benefits in invasive disease-free survival and distant relapse-free survival persisted, while the safety profile remained consistent with prior findings. Detailed results will be presented at an upcoming medical meeting, submitted to regulators and offered for publication in a peer-reviewed journal. Verzenio, a CDK4/6 inhibitor first approved in 2017 and cleared for adjuvant use in this patient group in 2021, generated US$5.3 billion in revenue last year. Lilly said the new survival data reinforce the drug’s position as standard care for high-risk early breast cancer and could drive broader adoption.
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