Lilly to present new clinical data for Verzenio (abemaciclib) and multiple novel pipeline programs at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting

Primary overall survival analysis from the Phase 3 monarchE study of Verzenio (abemaciclib) in HR+HER2-, node-positive, high-risk early breast cancer to be presented as a late-breaking oral presentation

Additional presentations showcase Lilly's robust oncology pipeline with data from studies of investigational therapies targeting FRα positive ovarian cancer, KRAS G12C-mutant lung cancer, FGFR3-altered bladder cancer, and PIK3CA-mutant advanced breast cancer

INDIANAPOLIS, Oct. 13, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that new data from across its oncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Annual Meeting, taking place October 17-21 in Berlin, Germany. These presentations highlight the breadth of Lilly's portfolio across treatment modalities and tumor types.

Presentation Highlights

Verzenio (abemaciclib; CDK4/6 inhibitor): In a late-breaking oral presentation, Lilly will share results from the landmark seven-year analysis of monarchE, including primary overall survival analysis and updated invasive disease-free survival and distant relapse-free survival, in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer. Additionally, in a mini-oral presentation, Lilly will share an in-depth analysis from monarchE examining the prognostic and predictive value of the Ki-67 index, pre- and post-neoadjuvant chemotherapy.

Olomorasib (investigational KRAS G12C  inhibitor): In a mini oral presentation, Lilly will share results from the Phase 1/2 study on the intracranial efficacy of olomorasib, a next-generation KRAS G12C inhibitor, in patients with KRAS G12C-mutant non-small cell lung cancer (NSCLC) who have active, untreated brain metastases.

LY4064809 (investigational pan-mutant-selective PI3Ka inhibitor): In a late-breaking oral presentation, Lilly will share updated results from the Phase 1/2 PIKALO-1 trial, a study of LY4064809 (STX-478), a pan-mutant-selective PI3Ka inhibitor, in PIK3CA-mutant advanced breast cancer and other solid tumors.

Vepugratinib (investigational FGFR3 inhibitor): In a mini oral presentation, Lilly will share updated results from the FORAGER-1 study, a first-in-human Phase 1 study of vepugratinib (LY3866288), a potent, highly isoform-selective FGFR3 inhibitor, in FGFR3-altered urothelial cancer.

LY4170156 (investigational ADC targeting FRα): In a poster presentation, Lilly will share updated safety and efficacy results from the Phase 1a/1b study of LY4170156 in patients with platinum-resistant ovarian cancer.

"At ESMO 2025, we're proud to showcase new clinical data from several studies that underscore Lilly's commitment to advancing cancer care, including the primary overall survival analysis for Verzenio in the Phase 3 monarchE trial, as well as updated safety and efficacy data from our FRα ADC, PI3Kα and FGFR3 programs, all of which are poised to advance to late stage studies over the next several months," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "These data reflect the meaningful progress we have made in strengthening our oncology portfolio and our dedication to improving outcomes for people living with cancer."

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

Abstract Title	Author	Presentation Type/#	Session Title	Session Date/Time (CEST)
Verzenio (abemaciclib; CDK4/6 inhibitor)
monarchE: Primary overall survival results of adjuvant abemaciclib plus endocrine therapy for high-risk, HR+, HER2-, early breast cancer	Stephen Johnston	Oral Abstract #LBA13	Proffered Paper session: Breast cancer, early stage	Friday, October 17   2:00-3:30 p.m. CEST
monarchE: Evaluation of prognostic and predictive value of Ki-67 index pre and post neoadjuvant chemotherapy (NAC) and changes following NAC	Miguel Martin	Mini Oral Abstract #295MO	Mini oral session: Breast cancer, early stage	Sunday, October 19   10:15-11:45 a.m. CEST
Olomorasib (investigational KRAS G12C inhibitor)
Intracranial efficacy of olomorasib, a second-generation KRAS G12C inhibitor, in patients with KRASG12C-mutant NSCLC who have active, untreated brain metastases	Philippe Cassier	Mini Oral Abstract #1846MO	Mini oral session 1: NSCLC metastatic	Sunday, October 19   8:30-10:00 a.m. CEST
LY4064809 (investigational pan-mutant-selective PI3Ka inhibitor)
A phase 1/2 trial of LY4064809 (STX-478), a pan-mutant-selective PI3Ka inhibitor in PIK3CA-mutant advanced breast cancer (ABC) and other solid tumors: Updated results from the PIKALO-1 study	Dejan Juric	Mini Oral Abstract #LBA26	Mini oral session: Breast cancer, metastatic	Monday, October 20   10:15-11:45 a.m. CEST
Vepugratinib (investigational FGFR3 inhibitor)
Phase 1 study of LY3866288, a potent, highly isoform-selective FGFR3 inhibitor in FGFR3-altered advanced solid tumors (FORAGER-1): Dose optimization	Alexandra Drakaki	Mini Oral Abstract #3070MO	Mini oral session 1: GU tumors, renal & urothelial	Sunday, October 19   8:30-10:00 a.m. CEST
LY4170156 (investigational ADC targeting FR α )
Results from the first-in-human phase 1 study of LY4170156, an antibody drug conjugate (ADC) targeting folate receptor alpha in recurrent platinum resistant high-grade serous ovarian cancer (HGSOC)	Isabelle Ray-Coquard	Poster Abstract #1067P	Gynaecological cancers	Saturday, October 18   12:00-12:45 p.m. CEST
Translational PK/PD modelling of LY4170156, an antibody-drug conjugate linked to exatecan via a novel cleavable polysarcosine linker	Bhavana Pothuri	Poster Abstract #236eP	Biomarkers & translational research (agnostic)	Monday, October 20   12:00-12:45 p.m. CEST
Inluriyo (imlunestrant; ER antagonist)
Inluriyo plus abemaciclib versus fulvestrant plus abemaciclib in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC): An indirect treatment comparison (ITC) of three phase 3 trials	François Clément Bidard	Poster Abstract #496P	Breast cancer metastatic	Monday, October 20   12:00-12:45 p.m. CEST

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

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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