Eli Lilly and Company (NYSE: LLY) reported today that patients with high-risk early breast cancer who have hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), or both have demonstrated a statistically significant improvement in overall survival when using their medication Verzenio® (abemaciclib) in conjunction with endocrine therapy.
The results are based on a seven-year analysis of the Phase 3 monarchE trial. In comparison to endocrine therapy alone, the study showed that Verzenio decreased the risk of death by 15.8% when used in conjunction with endocrine therapy. Since Verzenio is the first CDK4/6 inhibitor to demonstrate a notable overall survival benefit in this patient population, this represents a significant advancement.
For patients, survival is what matters most — and abemaciclib plus endocrine therapy represents the first contemporary medicine in over two decades to deliver a clear improvement in overall survival in the adjuvant setting,
These results represent an important step forward in the treatment of high-risk HR+, HER2− early breast cancer.
Stephen Johnston
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5,637 patients with HR+, HER2-, node-positive, high-risk early breast cancer were recruited for the global, randomised, open-label, Phase 3 monarchE trial. Overall survival (OS) was a crucial secondary endpoint, while invasive disease-free survival (IDFS) was the main goal of the trial.
Among the seven-year analysis’s main conclusions are:
- An ongoing improvement in distant relapse-free survival (DRFS) and invasive disease-free survival (IDFS).
- A 32% decrease in the incidence of metastatic illness in patients.
The safety profile of Verzenio was consistent with previous findings, with no new safety concerns identified.
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The most prevalent cancer in women worldwide is breast cancer. Ninety percent of all breast cancers are thought to be discovered early. The HR+, HER2-subtype accounts for about 70% of all cases of breast cancer. With these encouraging outcomes, Lilly’s Verzenio is well-positioned to have a big influence on how this prevalent type of breast cancer is treated.
In-depth findings from the monarchE trial will be submitted for publication in a peer-reviewed journal and presented at a future medical conference.
About Verzenio® (abemaciclib)
Verzenio is a CDK4/6 inhibitor, a type of targeted therapy. It slows the growth and division of cancer cells by blocking two proteins, cyclin-dependent kinases 4 and 6. It is taken orally twice a day.
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