(Breast Cancer) Verzenio Plus Hormone Therapy as Adjuvant Treatment: Is It Effective?
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On December 6, 2022, Dr. Stephen R. D. Johnston and colleagues from The Royal Marsden NHS Foundation Trust published interim analysis results in The Lancet Oncology from the monarchE Phase 3 clinical trial evaluating Verzenio (abemaciclib) plus hormone therapy as adjuvant treatment in patients with hormone receptor (HR)-positive, HER2-negative, lymph node-positive early breast cancer.
The monarchE Phase 3 clinical trial randomized 5,637 patients with HR+, HER2−, node-positive early breast cancer at high risk of recurrence in a 1:1 ratio to:
- Verzenio group: Verzenio 150 mg twice daily (up to 2 years) plus hormone therapy (up to 10 years) (N=2,808)
- Hormone therapy group: Hormone therapy alone (up to 10 years) (N=2,829)
The primary endpoint was invasive disease-free survival (IDFS). The secondary endpoint was overall survival (OS).
Results at a median follow-up of 42 months:
The primary endpoint of IDFS was not reached in either arm, consistent with the previous analysis. The 4-year IDFS rates were: Verzenio plus hormone therapy group: 85.8% vs. hormone therapy alone: 79.4%.
Safety:
Grade 3–4 adverse events included:
- Neutropenia: Verzenio + hormone therapy 19.6% (N=548/2,791) vs. hormone therapy alone 0.9% (N=24/2,800)
- Leukopenia: Verzenio + hormone therapy 11.4% vs. hormone therapy alone 0.4%
- Diarrhea: Verzenio + hormone therapy 7.8% vs. hormone therapy alone 0.2%
Serious adverse events occurred in 15.5% (N=433/2,791) in the Verzenio group vs. 9.1% (N=256/2,800) in the hormone therapy group. No deaths due to adverse events were confirmed in either group.
Conclusion: Based on the monarchE trial results, Dr. Johnston and colleagues concluded that Verzenio plus hormone therapy as adjuvant therapy demonstrated favorable 4-year IDFS outcomes in HR+, HER2−, node-positive early breast cancer patients at high risk of recurrence, confirming long-term clinical benefit.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00694-5/fulltext
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