Eli Lilly and Company has announced positive topline results from the primary overall survival (OS) analysis of the Phase III monarchE trial.
Treatment with 2 years of Verzenio plus endocrine therapy (ET) demonstrated a statistically significant and clinically meaningful improvement in OS compared with ET alone in patients with hormone receptor-positive (HR+), HER2-, node-positive high-risk early breast cancer.
The 7-year landmark analysis also demonstrated sustained benefits 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 2-year course of Verzenio, the overall safety profile of Verzenio was unchanged and consistent with previous reports.
"These new data are very important because they prove that taking Verzenio for just 2 years does indeed improve survival, a treatment opportunity that all eligible patients deserve to be offered as standard of care," said Karen Bell, Senior Medical Director of Oncology at Lilly Canada.
"We hope this outcome brings reassurance for Canadian patients and their families."