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Landmark 5-Year monarchE Outcome Data Demonstrate Verzenio® (abemaciclib)'s Long-Term Impact on Cancer Recurrence in High-Risk Early Breast Cancer

Published: 2023-10-20 12:00:00 ET

Impact of two years of adjuvant Verzenio treatment is observed well beyond the treatment period, reducing the risk of long-term recurrence by 32% and improving invasive disease-free survival by 7.6% at 5 years

These data reinforce two years of Verzenio plus endocrine therapy as the standard of care for these patients in this curative setting

Use of Verzenio as a treatment option in this setting is supported by an NCCN® Category 1 designation

INDIANAPOLIS, Oct. 20, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced five-year outcomes from a pre-planned analysis of the Phase 3 monarchE study evaluating two years of adjuvant Verzenio® (abemaciclib) in combination with endocrine therapy (ET) compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer (EBC) at a high risk of recurrence. These data were shared in a late-breaking presentation at the 2023 European Society for Medical Oncology (ESMO) Congress.

"The five-year time period is an established landmark for adjuvant breast cancer clinical trials and is an important milestone for patients and physicians in this curative setting," said Nadia Harbeck, M.D., Ph.D, Director of the Breast Center and Chair for Conservative Oncology, Department of OB&GYN, LMU University Hospital (Munich, Germany), monarchE investigator, and presenter of the results at the 2023 ESMO Congress. "These five-year monarchE data clearly demonstrate a carryover effect beyond the completion of two years of abemaciclib treatment, with the IDFS and DRFS curves continuing to separate, reinforcing confidence in the role of abemaciclib added to endocrine therapy in the adjuvant setting for those with a high risk of recurrence."

The data presented include results from a pre-specified analysis reflecting a median follow-up of 4.5 years. All patients have completed the Verzenio treatment course, with more than 80% of patients having been followed for at least two years after completion. In the intent-to-treat (ITT) population, the risk of developing invasive disease was reduced by 32% (HR=0.680, 95% CI: 0.599, 0.772; nominal p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.