From the Guidelines
Verzenio (abemaciclib) is a recommended treatment option for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer, particularly in combination with fulvestrant or an aromatase inhibitor, as it has shown to improve progression-free survival (PFS) and overall survival (OS) in clinical trials. The standard dosage of Verzenio is typically 150mg taken orally twice daily when used with hormone therapy, or 200mg twice daily when used alone 1. Verzenio works as a CDK4/6 inhibitor, blocking proteins that drive cancer cell growth.
Key Considerations
- Verzenio is usually prescribed in combination with an aromatase inhibitor (like letrozole) for postmenopausal women as initial therapy, or with fulvestrant for patients whose disease has progressed after hormone therapy 1.
- It can also be used as monotherapy after hormone therapy and chemotherapy have failed.
- Common side effects include diarrhea (which can be severe and requires management), fatigue, nausea, and low white blood cell counts 1.
- Regular blood tests are necessary to monitor for these effects.
- Verzenio differs from other CDK4/6 inhibitors (like Ibrance and Kisqali) in its continuous dosing schedule and unique side effect profile, making it an important option in breast cancer treatment.
Clinical Trial Evidence
- The MONARCH 2 phase III trial demonstrated an improved PFS and OS with the combination of abemaciclib and fulvestrant compared to fulvestrant alone in patients with HR-positive, HER2-negative advanced breast cancer who had progressed on prior endocrine therapy 1.
- The MONARCH trial also showed an improvement in PFS with the combination of abemaciclib and an aromatase inhibitor compared to aromatase inhibitor alone as first-line treatment for women with advanced HR-positive, HER2-negative breast cancer 1.
From the FDA Drug Label
VERZENIO® (abemaciclib) is indicated: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Verzenio is indicated for breast cancer in several scenarios, including:
- Early breast cancer: in combination with endocrine therapy for adjuvant treatment of HR-positive, HER2-negative, node-positive breast cancer at high risk of recurrence.
- Advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor as initial endocrine-based therapy
- in combination with fulvestrant for disease progression following endocrine therapy
- as monotherapy for disease progression following endocrine therapy and prior chemotherapy in the metastatic setting 2
From the Research
Verzenio for Breast Cancer
- Verzenio, also known as abemaciclib, is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor used in the treatment of breast cancer 3, 4, 5, 6.
- It has been shown to be effective in combination with endocrine therapy for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer 3, 4, 5, 6.
- The MONARCH 3 study demonstrated that abemaciclib plus a nonsteroidal aromatase inhibitor significantly improved progression-free survival (PFS) and objective response rate in patients with HR+, HER2- advanced breast cancer 3.
- A systematic review and meta-analysis of 22 studies involving 14,010 patients found that abemaciclib significantly improved PFS, overall response rate, and overall survival in patients with HR+, HER2- advanced or metastatic breast cancer 6.
Efficacy and Safety
- Abemaciclib has been shown to be effective in improving PFS and overall survival in patients with HR+, HER2- advanced or metastatic breast cancer 3, 4, 5, 6.
- The most common adverse events associated with abemaciclib include diarrhea, neutropenia, and leukopenia 3, 4, 5.
- A study found that abemaciclib increased the risk of adverse events in combination with fulvestrant and nonsteroidal aromatase inhibitors 6.
Real-World Evidence
- A real-world study found that abemaciclib was effective and safe in patients with HR+, HER2- metastatic breast cancer, with a median PFS of 16.5 months and an overall response rate of 55.1% 7.
- Another study found that abemaciclib plus a nonsteroidal aromatase inhibitor resulted in a clinically meaningful improvement in median overall survival in patients with HR+, HER2- advanced breast cancer 5.