Eli Lilly and Company anounced positive topline results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial. Treatment with two years of Verzenio plus endocrine therapy (ET) demonstrated a statistically significant and clinically meaningful improvement in OS compared to ET alone in patients with hormone receptor positive (HR+), HER2-, node-positive, high-risk early breast cancer.

The seven-year landmark analysis also demonstrated sustained benefit in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), reinforcing the consistency and durability of treatment effect across endpoints.

"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," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "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."

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.