Eli Lilly (NYSE:LLY) announced on Wednesday that its FDA-approved antitumor agent Verzenio, as part of a combination regimen, improved overall survival in a late-stage trial for certain patients with breast cancer.
The findings were based on a primary overall survival (OS) analysis of its Phase 3 monarchE trial, which involved more than 5,500 patients with hormone receptor-positive (HR+), HER2-, node-positive, high-risk early breast cancer across the globe.
Citing topline data, the Indiana-based drugmaker said that Verzenio plus endocrine therapy improved OS, a key secondary endpoint in monarchE, with a statistically significant and clinically meaningful effect versus endocrine therapy alone.
The analysis also indicated that the orally administered therapy sustained benefit in several clinical measures, including invasive disease-free survival, the study’s primary endpoint.
“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,” said Jacob Van Naarden, head of Lilly Oncology.
The company plans to present the data at a future medical event. It will also submit the findings for publication in a peer-reviewed journal and discuss the results with the global regulatory agencies.