Abemaciclib Combination Therapy Demonstrates Overall Survival Benefit in High-Risk Breast Cancer
New data reveal that abemaciclib, when combined with endocrine therapy (ET), considerably improves overall survival in patients with node-positive, high-risk, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.Findings released August 27, 2025, by Eli Lilly and Company demonstrate a survival benefit with two years of therapy.
Breast cancer is the second most diagnosed cancer globally and a leading cause of cancer-related death, responsible for nearly 666,000 deaths in 2022. Approximately 70% of all breast cancer cases are HR+,HER2-,meaning the tumor relies on estrogen and progesterone,and does not overexpress the HER2 protein. While early-stage HR+/HER2- breast cancer has a favorable prognosis, high-risk patients-those with positive nodal status, multiple positive nodes, large tumor size, or high tumor grade-are three times more likely to experience recurrence.
Abemaciclib, a CDK4/6 inhibitor, received FDA approval in March 2023 for expanded use in the adjuvant treatment of high-risk, HR+/HER2- early breast cancer when combined with ET. It was the first CDK4/6 inhibitor approved for this indication.
The drug is available as an oral tablet in dosages of 50 mg, 100 mg, 150 mg, and 200 mg, administered twice daily. Beyond early-stage disease, abemaciclib is also indicated for advanced or metastatic breast cancer, both as a first-line treatment alongside an aromatase inhibitor and in combination with fulvestrant for patients whose disease has progressed after prior ET. It can also be used as a single agent for advanced or metastatic disease following progression after both ET and chemotherapy.
“These data validate [abemaciclib] as the standard-of-care for patients with node-positive, high-risk disease and increase the urgency to ensure all eligible patients are treated,” stated Naarden in the Lilly news release.
REFERENCES
- Lilly’s Verzenio® (abemaciclib) increases overall survival in HR+, HER2-, high-risk early breast cancer with two years of therapy. Eli Lilly and Company. News release. August 27, 2025. Accessed September 2, 2025. https://www.prnewswire.com/news-releases/lillys-verzenio-abemaciclib-increases-overall-survival-in-hr-her2–high-risk-early-breast-cancer-with-two-years-of-therapy-302539340.html
- A Study of Nonsteroidal Aromatase inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal women With Breast cancer (MONARCH 3) Updated April 20, 2024. Accessed September 2, 2025. https://clinicaltrials.gov/study/NCT02246621
- FDA expands early breast cancer indication for abemaciclib with endocrine therapy. FDA. News release. March 3, 2023. Accessed September 2, 2025. https://www.fda.gov/drugs/resources-details-approved-drugs/fda-expands-early-breast-cancer-indication-abemaciclib-endocrine-therapy