Eli Lilly to share late-breaking and new Phase III results highlighting continued momentum in breast oncology at SABCS 2025

Eli Lilly and Company announced that new data from across its breast oncology portfolio and pipeline will be featured at the San Antonio Breast Cancer Symposium (SABCS), taking place December 9–12 in San Antonio, Texas. These updates reflect Lilly’s continued progress across key pathways in hormone receptor–positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) breast cancer, the most common form of breast cancer.¹

Presentation Highlights

Inluriyo (imlunestrant; estrogen receptor antagonist)
In a late-breaking oral presentation, Lilly will share updated results from the Phase III EMBER-3 trial evaluating Inluriyo (imlunestrant) alone and in combination with Verzenio (abemaciclib), in patients with ER+, HER2– advanced or metastatic breast cancer. The presentation will feature a pre-specified interim overall survival (OS) analysis, with updates on progression-free survival (PFS) and time to chemotherapy (TTC). In addition, a poster presentation will provide results of an exploratory analysis of early changes in circulating tumor DNA (ctDNA) and correlation to clinical outcomes.

Verzenio (abemaciclib; CDK4/6 inhibitor)
In a poster presentation, Lilly will share results from a subgroup analysis of the Phase III monarchE trial, evaluating adjuvant abemaciclib plus endocrine therapy by nodal status in patients with HR+, HER2– high-risk early breast cancer. These data expand on recent results at ESMO 2025, which showed that adjuvant abemaciclib plus endocrine therapy prolonged overall survival and sustained long-term improvements in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS).

LY4064809 / STX-478 (investigational pan-mutant-selective PI3Kα inhibitor)
In a poster presentation, Lilly will share findings from PIKALO-1, the ongoing Phase 1/II study evaluating LY4064809 alone and in combination with endocrine therapy and CDK4/6 inhibitors in patients with PIK3CA-mutant HR+, HER2– advanced breast cancer, including updated data on safety, efficacy, biomarkers, and analyses across pre-diabetic, diabetic, and non-diabetic subgroups. LY4064809 is planned to advance into the Phase 3 PIKALO-2 study (NCT07174336), for which a dose optimization lead-in is ongoing.

“At SABCS 2025, we’re proud to showcase new data across our portfolio of investigational and approved breast cancer medicines, addressing the three most important biologic targets in HR+ breast cancer: CDK4/6, the estrogen receptor, and PI3K,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. “Together, these presentations reflect the continued momentum of Lilly’s breast oncology portfolio and our commitment to translating biologic conviction into meaningful progress for people living with breast cancer.”

View a full list of abstract titles and viewing details HERE.