Eli Lilly and Company, listed on the NYSE as LLY, announced that new data from its breast oncology pipeline and approved medicines will be highlighted at the San Antonio Breast Cancer Symposium, taking place December 9 to 12 in San Antonio, Texas. The updates reflect Lilly’s ongoing progress in addressing hormone receptor-positive, HER2-negative breast cancer, which is the most common type of breast cancer.
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For Inluriyo, Lilly will present updated findings from the Phase 3 EMBER-3 trial evaluating the drug alone and combined with Verzenio in patients with advanced or metastatic ER-positive, HER2-negative breast cancer. The oral presentation will include a pre-specified interim overall survival analysis as well as updates on progression-free survival and time to chemotherapy. A poster will show exploratory analyses of early changes in circulating tumor DNA and how these relate to clinical outcomes.
Verzenio data will be presented in a poster featuring a subgroup analysis of the Phase 3 monarchE trial. This evaluation examines the addition of adjuvant abemaciclib to endocrine therapy by nodal status in patients with high-risk, early HR-positive, HER2-negative breast cancer. These findings build on previous data presented at ESMO 2025, which demonstrated improved overall survival and sustained benefits in invasive disease-free survival and distant relapse-free survival.
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Lilly will also present findings from the ongoing Phase 1/2 PIKALO-1 study of LY4064809, an investigational pan-mutant-selective PI3Kα inhibitor. The poster will share data on safety, efficacy, biomarkers, and subgroup analyses for pre-diabetic, diabetic, and non-diabetic patients. The drug is expected to advance into the Phase 3 PIKALO-2 trial, for which dose optimization is currently underway.
Jacob Van Naarden, executive vice president and president of Lilly Oncology, stated that the SABCS presentations highlight progress across Lilly’s investigational and approved therapies targeting CDK4/6, the estrogen receptor, and PI3K in HR-positive breast cancer. He emphasized that these updates reflect the company’s commitment to turning biological understanding into meaningful advances for people living with breast cancer.
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