(Breast Cancer) Verzenio Plus Standard Hormone Therapy: Is It Effective?
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On June 16, 2020, Eli Lilly announced results from the monarchE Phase 3 clinical trial evaluating the efficacy and safety of the CDK4/6 inhibitor Verzenio (abemaciclib) plus standard hormone therapy in patients with hormone receptor (HR)-positive, HER2-negative early breast cancer at high risk of recurrence.
The monarchE Phase 3 clinical trial was a multi-center, international study randomizing 5,637 patients with HR+, HER2-negative early breast cancer at high risk of recurrence in a 1:1 ratio. The primary endpoint was invasive disease-free survival (IDFS), and secondary endpoints included overall survival (OS) and safety. Verzenio treatment continued up to 2 years and standard hormone therapy for at least 5 years, absent intolerable adverse effects.
- Verzenio group: Verzenio 150 mg twice daily plus standard hormone therapy
Approximately 30% of HR+, HER2-negative early breast cancer patients experience recurrence, and even those diagnosed and treated early may face difficult-to-treat disease upon recurrence. This unmet need motivated the initiation of the monarchE trial.
Results: The primary endpoint of IDFS was significantly improved in the Verzenio group compared to the standard hormone therapy group. Safety findings were consistent with previously established adverse event profiles for Verzenio, with no new safety signals identified.
Conclusion: Eli Lilly's Maura Dickler concluded that the CDK4/6 inhibitor Verzenio plus standard hormone therapy significantly improved outcomes compared to current standard-of-care in HR+, HER2-negative early breast cancer patients at high risk of recurrence, representing a promising new treatment option.
Disclaimer: Medical Supporter translates overseas clinical trial data and pharmaceutical information for informational purposes only. This does not constitute encouragement to participate in clinical trials or use any new drug. Translation materials are for reference only, not prescribing guidelines. Please consult with your healthcare provider for medical decisions.
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