Eli Lilly announces topline results from monarchE trial

Eli Lilly (LLY) announced topline results from the primary overall survival analysis of the Phase 3 monarchE trial. Treatment with two years of Verzenio plus endocrine therapy demonstrated a statistically significant and clinically meaningful improvement in OS compared to ET alone in patients with hormone receptor positive, HER2-, node-positive, high-risk early breast cancer. The seven-year landmark analysis also demonstrated sustained benefit in invasive disease-free survival and distant relapse-free survival, reinforcing the consistency and durability of treatment effect across endpoints. With all patients having completed or discontinued the two-year course of Verzenio, the overall safety profile of Verzenio was unchanged and consistent with previous reports. Detailed results will be presented at a future medical meeting, submitted for publication in a peer-reviewed journal and discussed with regulatory bodies.