Summary

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• Verzenio (abemaciclib) is used in combination with endocrine therapy for treating early breast cancer in patients at high risk of recurrence. It is also indicated in combination with other therapies for advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. Additionally, Verzenio can be used as a monotherapy in patients with advanced breast cancer that has progressed following endocrine therapy and chemotherapy.
• This summary is based on the review of nine systematic review(s)/meta-analysis(es). ^[1-9]
• CDK4/6 inhibitors, including abemaciclib, are effective in prolonging overall survival (OS) and progression-free survival (PFS) in patients with hormone receptor-positive (HR+), HER2-negative breast cancer, with abemaciclib showing specific benefit in invasive disease-free survival (IDFS) when combined with endocrine therapy (ET) for high-risk, node-positive early breast cancer.
• Comparative Effectiveness: CDK4/6 inhibitors significantly extend PFS compared to PI3K/AKT/mTOR inhibitors, although no significant differences were observed in OS. Among CDK4/6 inhibitors, abemaciclib demonstrates fewer severe neutropenia incidents and enhanced outcomes when added to fulvestrant, improving both PFS and OS compared to fulvestrant alone.
• Population-Specific Effectiveness: The effectiveness of CDK4/6 inhibitors, including abemaciclib, in extending PFS is significant across both visceral and non-visceral subgroups of metastatic breast cancer patients, with particular efficacy observed in HR+, HER2-negative, node-positive early breast cancer patients at high risk of recurrence when combined with ET.
• CDK4/6 inhibitors, including abemaciclib, are associated with significant adverse events, with abemaciclib particularly noted for gastrointestinal toxicities such as diarrhea. Additionally, abemaciclib had lower rates of severe neutropenia compared to palbociclib and ribociclib.
• Abemaciclib increased the risk of venous thromboembolism (VTE) and was weakly associated with arterial thromboembolism (ATE). It was also linked to dermatologic reactions, including alopecia, skin rash, and Stevens-Johnson syndrome.
• There was a noted higher incidence of diarrhea in postmenopausal women treated with abemaciclib.