Data show adjuvant Verzenio plus endocrine therapy extends overall survival and sustains long-term improvements in invasive disease-free survival
Eli Lilly and Company is set to present significant new data from its breast oncology portfolio at the upcoming San Antonio Breast Cancer Symposium (SABCS), December 9–12. The updates underscore Lilly’s ongoing progress in tackling hormone receptor–positive (HR+), HER2– breast cancer—the most common form of the disease.
At the forefront is Inluriyo (imlunestrant), Lilly’s oral estrogen receptor antagonist. A late-breaking oral presentation will reveal Phase 3 EMBER-3 trial results, including a pre-specified interim overall survival analysis and updates on progression-free survival and time to chemotherapy. The session will also highlight exploratory findings linking early changes in circulating tumor DNA to clinical outcomes.
Verzenio (abemaciclib), Lilly’s CDK4/6 inhibitor, will be featured in a poster presentation detailing a subgroup analysis from the Phase 3 monarchE trial. Data show adjuvant Verzenio plus endocrine therapy extends overall survival and sustains long-term improvements in invasive disease-free survival and distant relapse-free survival in high-risk early breast cancer patients.
Additionally, Lilly will present early data from LY4064809, evaluated alone and in combination with endocrine therapy and CDK4/6 inhibitors for PIK3CA-mutant advanced breast cancer. The Phase 1/2 PIKALO-1 study provides updates on safety, efficacy, biomarkers, and analyses across diabetic subgroups, with plans to advance LY4064809 into the Phase 3 PIKALO-2 trial.
“At SABCS 2025, we’re proud to showcase new data addressing the three key biologic targets in HR+ breast cancer—CDK4/6, estrogen receptor, and PI3K,” said Jacob Van Naarden, EVP and President of Lilly Oncology. “These presentations highlight the continued momentum of Lilly’s breast oncology portfolio and our commitment to meaningful progress for people living with breast cancer.”
Inluriyo is FDA-approved for adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer following at least one line of endocrine therapy. Lilly continues to explore its potential in combination with abemaciclib and as an adjuvant therapy in early breast cancer.
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