Bristol Myers Squibb and Lilly Showcase Major Oncology Data at ESMO 2025
核心洞察
Bristol Myers Squibb (搜索) will present data from over 50 studies at ESMO 2025, including first-in-class results from izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific ADC that received FDA Breakthrough Therapy designation for EGFR (搜索)-mutated NSCLC.
Lilly will share primary overall survival analysis from the seven-year monarchE study of Verzenio (abemaciclib) in high-risk early breast cancer, marking a significant milestone in CDK4/6 (搜索) inhibitor development.
Both companies will present late-breaking data on novel pipeline programs targeting diverse tumor types, including colorectal cancer, urothelial carcinoma, and various solid tumors with specific genetic alterations.
Two pharmaceutical giants are set to showcase significant advances in cancer treatment at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21 in Berlin, Germany. Bristol Myers Squibb (搜索) and Eli Lilly will present data spanning multiple tumor types and novel therapeutic approaches, highlighting the continued evolution of precision oncology.
Bristol Myers Squibb Unveils First-in-Class ADC Results
Bristol Myers Squibb (搜索) announced it will present data from more than 50 company-sponsored studies, investigator-sponsored studies, and collaborations across over 10 cancer types. The company's most notable presentation will feature the first disclosure of results from a global Phase 1 study of izalontamab brengitecan (iza-bren; BL-B01D1), a potential first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC).
"This year's ESMO meeting is a testament to the continued advancement of our oncology portfolio and potential of our research pipeline, driven by novel mechanisms and unique modalities," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology and Cell Therapy at Bristol Myers Squibb (搜索).
The iza-bren study enrolled patients with metastatic non-small cell lung cancer (NSCLC) and other solid tumors. Results from this trial supported the FDA's Breakthrough Therapy designation for iza-bren in patients with previously treated advanced EGFR (搜索)-mutated NSCLC, underscoring the potential clinical significance of this novel therapeutic approach.
Opdivo Combination Shows Long-term Benefits
Bristol Myers Squibb (搜索) will also present late-breaking updates of progression-free survival (PFS) and the first disclosure of overall survival (OS) from CheckMate-8HW, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo or investigator's choice of chemotherapy in first- and all-line settings in MSI-H/dMMR metastatic colorectal cancer (mCRC).
Additional long-term follow-up data will include five-year disease-free survival (DFS), overall survival (OS) and circulating tumor DNA (ctDNA) results from CheckMate-274, which evaluated adjuvant Opdivo in adult patients with high-risk muscle-invasive urothelial carcinoma after radical resection. The company will also present a nine-year final analysis of the CheckMate-238 study comparing adjuvant Opdivo versus Yervoy in patients with resected advanced melanoma.
Lilly Presents Landmark Verzenio Survival Data
Eli 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 data for Verzenio (abemaciclib). The study evaluated the CDK4/6 (搜索) inhibitor in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast 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," said Jacob Van Naarden, executive vice president and president of Lilly Oncology.
Novel Pipeline Programs Target Specific Mutations
Lilly will present data from multiple investigational therapies targeting specific genetic alterations. The company will share Phase 1/2 results on the intracranial efficacy of olomorasib, a next-generation KRAS G12C (搜索) inhibitor, in patients with KRAS G12C-mutant non-small cell lung cancer (NSCLC) who have active, untreated brain metastases.
Updated results from the Phase 1/2 PIKALO-1 trial will showcase LY4064809 (搜索) (STX-478), a pan-mutant-selective PI3Kα (搜索) inhibitor, in PIK3CA-mutant advanced breast cancer and other solid tumors. The company will also present data from the FORAGER-1 study of vepugratinib (搜索) (LY3866288), a potent, highly isoform-selective FGFR3 (搜索) inhibitor, in FGFR3-altered urothelial cancer.
ADC Technology Advances
Lilly will share updated safety and efficacy results from the Phase 1a/1b study of LY4170156, an investigational ADC targeting folate receptor alpha (FRα (搜索)), in patients with platinum-resistant ovarian cancer. This next-generation ADC was designed to target FRα across expression levels with improved therapeutic index.
The presentations at ESMO 2025 demonstrate both companies' commitment to addressing diverse tumor types and hard-to-treat populations through novel mechanisms and unique modalities. The data spans from early-phase studies of investigational agents to long-term follow-up of established therapies, providing insights into the evolving landscape of precision oncology.