Lilly to highlight progress across key programs in early and advanced hormone receptor-positive breast cancer at the 2025 San Antonio Breast Cancer Symposium

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

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

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."

A full list of abstract titles and viewing details are listed below:

For more information on Lilly's Oncology pipeline click here.

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.

INDICATION FOR INLURIYO (imlunestrant)

INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

IMPORTANT SAFETY INFORMATION FOR INLURIYO 

Warnings and Precautions — Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, Inluriyo can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, oral administration of imlunestrant to pregnant rats during the period of organogenesis led to embryo-fetal mortality and structural abnormalities at maternal exposures that were below the human exposure at the recommended dose based on area under the curve (AUC). Avoid the use of imlunestrant in pregnant women. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Inluriyo and for 1 week after the last dose.

Serious and Fatal Adverse Reactions 

Serious adverse reactions occurred in 10% of patients who received Inluriyo. Serious adverse reactions in >1% of patients included pleural effusion (1.2%). Fatal adverse reactions occurred in 1.8% of patients who received Inluriyo, including cardiac arrest, acute myocardial infarction, right ventricular failure, hypovolemic shock, and upper gastrointestinal hemorrhage (each 0.3%).

Most Common Adverse Reactions 

The most common adverse reactions (incidence ≥10%), including laboratory abnormalities, in patients who received Inluriyo were: hemoglobin decreased (30%), musculoskeletal pain (30%), calcium decreased (26%), neutrophils decreased (26%), AST increased (25%), fatigue (23%), diarrhea (22%), ALT increased (21%), triglycerides increased (21%), nausea (17%), platelets decreased (16%), constipation (10%), cholesterol increased (10%), and abdominal pain (10%).

Drug Interactions 

Imlunestrant is a CYP3A substrate. Avoid concomitant use of Inluriyo with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce the dosage of Inluriyo. Avoid concomitant use of Inluriyo with strong CYP3A inducers. If concomitant use cannot be avoided, increase the dosage of Inluriyo.

Imlunestrant inhibits both P-gp and BCRP. Avoid concomitant use unless otherwise recommended in the Prescribing Information for P-gp or BCRP substrates where minimal concentration changes may lead to serious adverse reactions.

Use in Specific Populations — Lactation 

Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with Inluriyo and for 1 week after the last dose.

Use in Specific Populations — Hepatic Impairment 

Reduce the dose of Inluriyo for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. No dosage adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A).

Inluriyo (imlunestrant) is available as 200 mg tablets.

Please click to access Prescribing Information for Inluriyo. 

IN HCP ISI M APP

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.

INDICATIONS FOR VERZENIO

VERZENIO is a kinase inhibitor indicated:

• in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
• in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
• in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
• as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)

Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of the first diarrhea event ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction.

Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.

Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio. Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in

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