Data includes seven-year results from monarchE trial and updates on multiple investigational cancer therapies.
Eli Lilly and Company (NYSE: LLY) announced today that it will present new data from a broad spectrum of its oncology portfolio at the upcoming European Society for Medical Oncology (ESMO) Annual Meeting, to be held October 17–21 in Berlin, Germany. These data span several tumor types and treatment modalities, reflecting the company’s commitment to advancing science and improving outcomes for people living with cancer.
The presentations will include updates on Verzenio® (abemaciclib) and a range of investigational therapies, including olomorasib, LY4064809, vepugratinib, LY4170156, and inluriyo (imlunestrant). Taken together, the data provide insight into Lilly’s advancing pipeline and potential next-generation treatments for difficult-to-treat cancers.
“At ESMO 2025, we’re proud to showcase new clinical data from several studies that underscore Lilly’s commitment to advancing cancer care,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. “This includes the primary overall survival analysis for Verzenio in the monarchE trial, as well as promising updates from our FRα ADC, PI3Kα, and FGFR3 programs—each of which is poised to move into late-stage development in the coming months. These data reflect the meaningful progress we’ve made in strengthening our oncology portfolio and deepening our impact on patient outcomes.”
Key Presentation Highlights at ESMO 2025
Verzenio® (abemaciclib; CDK4/6 inhibitor)
One of the centerpiece presentations at ESMO 2025 will be new data from the monarchE trial, in which Verzenio is being evaluated in combination with endocrine therapy in patients with high-risk, hormone receptor-positive (HR+), HER2-negative early breast cancer. A late-breaking oral presentation will reveal seven-year overall survival data, along with updated invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) results.
Additionally, a mini oral presentation will provide a detailed analysis of the Ki-67 index as both a prognostic and predictive biomarker—pre- and post-neoadjuvant chemotherapy—offering new insight into how Verzenio may benefit patients with differing tumor biology.
- Lead investigators: Stephen Johnston (LBA13) and Miguel Martin (295MO)
- Presentation dates: October 17 and 19
Olomorasib (investigational KRAS G12C inhibitor)
Lilly will also share updated results from its Phase 1/2 trial of olomorasib, a next-generation KRAS G12C inhibitor, specifically in patients with non-small cell lung cancer (NSCLC) who have active, untreated brain metastases. This mini oral presentation will explore olomorasib’s intracranial efficacy, addressing a historically underserved patient population with high unmet need.
- Lead investigator: Philippe Cassier (1846MO)
- Presentation date: October 19
LY4064809 (pan-mutant-selective PI3Ka inhibitor)
A late-breaking mini oral presentation will provide an update from the PIKALO-1 Phase 1/2 trial of LY4064809 (also known as STX-478). This investigational agent is being evaluated in PIK3CA-mutant advanced breast cancer and other solid tumors. The presentation will include data on safety, efficacy, and biomarker-driven insights that may support advancement to Phase 3 studies.
- Lead investigator: Dejan Juric (LBA26)
- Presentation date: October 20
Vepugratinib (investigational FGFR3 inhibitor)
In the FORAGER-1 Phase 1 study, vepugratinib (LY3866288) has shown potential in FGFR3-altered urothelial cancer. Lilly will present new findings from its dose-optimization cohort during a mini oral session, underscoring the drug’s isoform-selective mechanism of action.
- Lead investigator: Alexandra Drakaki (3070MO)
- Presentation date: October 17
LY4170156 (ADC targeting folate receptor alpha – FRα)
Two poster presentations will highlight updates from the first-in-human Phase 1a/1b study of LY4170156, an antibody-drug conjugate targeting FRα in platinum-resistant ovarian cancer. The data will include both efficacy and safety findings and insights from translational PK/PD modeling.
- Lead investigators: Isabelle Ray-Coquard (1067P), Bhavana Pothuri (236eP)
- Presentation dates: October 18 and 20
Inluriyo™ (imlunestrant; oral ER antagonist)
Lilly will also present a poster on inluriyo, evaluating its efficacy when combined with Verzenio versus fulvestrant plus Verzenio in ER+, HER2- advanced breast cancer. This indirect treatment comparison pulls data from three different Phase 3 trials and may inform future head-to-head studies or clinical decision-making.
- Lead investigator: François Clément Bidard (496P)
- Presentation date: October 20
Lilly’s participation at ESMO 2025 highlights the strategic growth and evolution of its oncology portfolio, which includes a mix of targeted therapies, antibody-drug conjugates, and pathway-selective inhibitors. The company continues to expand its research into biomarker-driven and tumor-specific treatment approaches, with multiple programs advancing toward late-stage development and potential regulatory submissions in the near future.
For a full list of Lilly’s ESMO 2025 presentations, including times, locations, and abstract numbers, please visit the official ESMO Congress program or visit Lilly’s oncology pipeline website for more information.
