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Updated results from the Phase 3 EMBER-3 trial for Inluriyo™ (imlunestrant) alone and in combination with Verzenio® (abemaciclib) in ER+, HER2– metastatic breast cancer to be presented as a late-breaking oral presentation
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Updated safety and efficacy data to be presented from PIKALO-1, the Phase 1/2 trial of Lilly's pan-mutant-selective PI3Kα inhibitor, which will be advanced into the Phase 3 PIKALO-2 study
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New subgroup analysis from the Phase 3 monarchE trial that explores outcomes by nodal status for Verzenio plus endocrine therapy in HR+, HER2– high-risk early breast cancer
INDIANAPOLIS, Nov. 24, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today 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 3 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 3 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 1/2 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."
About InluriyoTM (imlunestrant)
Inluriyo (imlunestrant) is an oral estrogen receptor antagonist that delivers continuous ER inhibition, including in ESR1-mutant cancers. The estrogen receptor (ER) is the key therapeutic target for patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–) breast cancer. Inluriyo is a U.S. FDA approved oral prescription medicine. Inluriyo is also currently being studied in combination with abemaciclib for advanced breast cancer and as an adjuvant treatment in early breast cancer, including: NCT04975308, NCT05514054 and NCT04188548.
About Verzenio (abemaciclib)
Verzenio (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic settings.
Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is currently authorized for use in more than 90 counties around the world. For full details on indicated uses of Verzenio in HR+, HER2- breast cancer, please see full Prescribing Information, available at www.Verzenio.com.
About LY4064809
LY4064809 (STX-478) is an investigational, oral, next-generation inhibitor phosphoinositide 3-kinase alpha (PI3Kα) inhibitor designed to selectively target tumors with PIK3CA mutations while sparing wild-type PI3Kα. Activating mutations in the PIK3CA gene (which encodes PI3Kα enzyme) are oncogenic drivers present in approximately 40% of hormone receptor positive (HR+)/HER2-negative breast cancers and occur at lower frequencies in many other cancers.3,4 LY4064809 is currently being studied in patients with HR+ breast cancer and other solid tumors with PIK3CA mutations, NCT05768139 and is planned to advance into the Phase 3 PIKALO-2 study, NCT07174336.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.
References & Endnotes
1.American Cancer Society. (2023). Breast cancer facts & figures 2023–2024. American Cancer Society, Inc.