Eisai announced the presentation of comprehensive clinical research across its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2025, taking place in Berlin, Germany from October 17 to 21. The most notable presentation features 5-year overall survival data from the Phase 3 Study 309/KEYNOTE-775 trial, which evaluated lenvatinib (LENVIMA®) plus pembrolizumab (KEYTRUDA®) versus treatment of physician's choice for patients with advanced endometrial carcinoma.
Long-Term Survival Data Reinforces Treatment Efficacy
The 5-year overall survival follow-up data from Study 309/KEYNOTE-775 (NCT03517449; Abstract #1119P) provides deeper insights into long-term treatment outcomes for patients with advanced endometrial carcinoma. According to Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc., "The 5-year overall survival follow-up from Study 309/KEYNOTE-775 being presented at ESMO highlights the consistency of the study data over time, supporting the established role of lenvatinib plus pembrolizumab in the treatment landscape of endometrial cancer."
Comprehensive Endometrial Cancer Research Portfolio
Beyond the landmark 5-year data, Eisai's ESMO presentations encompass additional endometrial cancer research, including 1-year follow-up results from the Phase 3 LEAP-001 study in first-line advanced or recurrent endometrial carcinoma (NCT03884101; Abstract #1114P). The company will also present a combined analysis examining post-(neo)adjuvant therapy outcomes from both the Study 309/KEYNOTE-775 and LEAP-001 studies (Abstract #1124P).
Novel Pipeline Approaches Target Wnt Signaling
Research from Eisai's pipeline includes clinical and biomarker results from Study 102 evaluating E7386, a CREB-binding protein (CBP)/β-catenin interaction inhibitor, in combination with lenvatinib in patients with advanced or recurrent endometrial carcinoma (NCT04008797; Abstract #1153P). E7386 is designed to block the protein-protein interaction between CBP and β-catenin, resulting in the inhibition of Wnt/β-catenin pathway-dependent gene expression. The compound is expected to inhibit not only ligand-dependent activation but also activation caused by gene mutations in Wnt signaling factors such as adenomatous polyposis coli (APC) and β-catenin.
Renal Cell Carcinoma Data Completes Oncology Portfolio
In renal cell carcinoma (RCC), final analysis data from the CLEAR study comparing lenvatinib plus pembrolizumab versus sunitinib in patients with advanced RCC with or without bone metastases will be presented (NCT02811861; Abstract #2603P). This data adds to the comprehensive evidence base supporting the lenvatinib plus pembrolizumab combination across multiple cancer types.
Strategic Collaboration Drives Development
The lenvatinib plus pembrolizumab combination research is conducted through the strategic collaboration between Eisai and Merck established in March 2018. Under this agreement, the companies jointly develop, manufacture and commercialize lenvatinib, both as monotherapy and in combination with Merck's anti-PD-1 therapy pembrolizumab through the LEAP (LEnvatinib And Pembrolizumab) clinical program. The combination is currently approved in the U.S., EU, Japan and other countries for the treatment of advanced RCC and certain types of advanced endometrial carcinoma.
Mechanism of Action and Current Approvals
Lenvatinib is a multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1, VEGFR2, and VEGFR3, along with other kinases implicated in pathogenic angiogenesis, tumor growth, and cancer progression, including fibroblast growth factor (FGF) receptors FGFR1-4, PDGFRA, KIT, and RET. In syngeneic mouse tumor models, the combination of lenvatinib with an anti-PD-1 monoclonal antibody decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity compared to either treatment alone.
The presentations underscore Eisai's commitment to generating long-term evidence that patients, families, and healthcare providers rely on to make informed treatment decisions, reflecting the company's dedication to addressing unmet medical needs and advancing treatment options for people living with cancer.
