Abemaciclib Combination Therapyโค Demonstrates Overall Survival Benefit in High-Riskโค Breastโ Cancer
New data reveal that abemaciclib, when combined with endocrine therapy (ET), considerablyโ improves overall survival in patients with node-positive, high-risk, hormone โฃreceptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.Findings released August 27, 2025, by Eli Lilly and Companyโฃ demonstrate a survival benefit with โtwo โyears of therapy.
Breast cancer is theโข second most diagnosed cancer โglobally and โa leading cause ofโ cancer-related death, responsible for nearly 666,000โข deaths in 2022. Approximately 70% โof all breast cancer cases are HR+,HER2-,meaning โtheโ tumor relies onโข estrogen and progesterone,and does not overexpress the HER2 protein.โข While โearly-stage HR+/HER2- breast cancer has a favorable prognosis, high-risk patients-thoseโ with positive nodal status, multiple positive nodes, largeโฃ tumorโ size, or highโข tumor โขgrade-are three times more likely to experience โคrecurrence.
Abemaciclib, a โCDK4/6 โฃinhibitor, received FDA approval in March 2023 for expanded useโค in the adjuvant treatment of high-risk, HR+/HER2- early breast cancer when combined with ET. It was the first CDK4/6 โinhibitor approvedโค for this indication.
The drug โis available asโ an oral tablet in dosages of 50 mg, 100 mg, 150 mg, and 200 โmg, administeredโ twice daily. Beyond early-stage disease, โabemaciclib is also indicated for advanced or metastatic breast cancer, โboth โas a first-line treatment alongside an aromatase inhibitor and in combination withโฃ fulvestrant for patients whose disease has progressed after prior ET. It can also be used as a โsingleโค agent for advanced or metastatic disease โfollowing progression after bothโค ET and chemotherapy.
“These data โvalidate [abemaciclib] as the standard-of-care โfor patients with node-positive, โฃhigh-risk disease and increase the โurgency โคto ensure all eligible patients are treated,” stated Naarden โin the Lillyโฃ news โrelease.
REFERENCES
- Lilly’s Verzenioยฎ (abemaciclib) increases overall survival inโ HR+, HER2-, high-risk early breast cancer with two years of therapy. Eli Lilly and Company. News release. August 27, 2025. Accessed September 2,โ 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 โคPlus Abemaciclib โ(LY2835219) inโ Postmenopausal womenโ With Breast cancer (MONARCH 3) Updated April 20, 2024. Accessed September 2, 2025. https://clinicaltrials.gov/study/NCT02246621
- FDA expands early breast cancer indication forโ 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