What's Happening?
Eli Lilly has announced significant findings from the monarchE trial, revealing that its CDK4/6 inhibitor Verzenio reduces the risk of death by 15.8% when used as adjuvant treatment for early-stage HR-positive,
HER2-negative breast cancer. The results, presented at the ESMO cancer congress, show a clear overall survival benefit of adding two years of Verzenio treatment to standard endocrine therapy. The trial demonstrated an 86.8% overall survival rate compared to 85% for endocrine therapy alone. Additionally, Verzenio reduced the development of metastatic disease by 32% compared to endocrine therapy alone.
Why It's Important?
These findings are crucial for the breast cancer treatment landscape, as Verzenio is the first contemporary therapy in over two decades to reduce the risk of death in this type of cancer. The results could help Eli Lilly maintain its competitive edge against Novartis' Kisqali, which has not achieved an increase in overall survival in similar trials. The data supports the potential for regulatory filings to extend Verzenio's label, which could enhance its market position and provide more treatment options for patients.
What's Next?
Eli Lilly plans to use the monarchE trial results as the basis for regulatory filings to extend Verzenio's label. This could lead to broader use of the drug in early-stage HR-positive, HER2-negative breast cancer treatment. The competition between Verzenio and Kisqali is likely to intensify, with both companies seeking to expand their market share through new indications and improved clinical outcomes.
Beyond the Headlines
The monarchE trial results highlight the importance of long-term follow-up in assessing the impact of cancer treatments on survival outcomes. While Verzenio shows promise in reducing relapse and metastatic disease, the modest difference in overall survival suggests the need for continued research into post-relapse outcomes and the long-term benefits of adjuvant therapies.
