NUTLEY, N.J., Oct. 2, 2025 — Eisai Inc. announced today the presentation of its expansive oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025, taking place in Berlin, Germany, from October 17 to 21. Among the highlights is five-year overall survival data from Phase 3 Study 309/KEYNOTE-775, evaluating lenvatinib (LENVIMA®) in combination with pembrolizumab (KEYTRUDA®) for advanced endometrial carcinoma. Additional data will be presented in renal cell carcinoma and pipeline investigations including E7386, a CBP/β-catenin interaction inhibitor.
Science SignificanceAVB-114
Eisai’s presentations emphasize long-term efficacy and durability of responses. Study 309/KEYNOTE-775 compares lenvatinib plus pembrolizumab versus treatment of physician’s choice in advanced endometrial carcinoma, providing critical five-year overall survival data for patients with progressive disease (NCT03517449; Abstract #1119P). Complementary research includes LEAP-001 one-year follow-up results in first-line advanced or recurrent endometrial carcinoma (NCT03884101; Abstract #1114P) and a combined analysis of post-(neo)adjuvant therapy outcomes across both studies (Abstract #1124P). In renal cell carcinoma, the final analysis from the CLEAR study examines lenvatinib plus pembrolizumab versus sunitinib, including patients with and without bone metastases (NCT02811861; Abstract #2603P). These studies demonstrate robust, consistent outcomes over time and further reinforce the clinical utility of lenvatinib combinations across multiple tumor types.
Regulatory Significance
Lenvatinib, in combination with pembrolizumab, is approved in the U.S., EU, Japan, and other regions for advanced endometrial carcinoma and renal cell carcinoma, and as monotherapy for differentiated thyroid cancer (DTC) and unresectable hepatocellular carcinoma (HCC). LENVIMA combined with everolimus is also approved for RCC after prior anti-angiogenic therapy. These approvals are based on robust clinical efficacy and manageable safety profiles, including evidence from multi-year follow-ups. Eisai emphasizes that investigational combinations, including lenvatinib plus E7386, remain under clinical investigation and are not yet FDA-approved. The company continues to generate regulatory-compliant data to support future approvals and potential label expansions.
Business Significance
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Eisai and Merck (MSD outside the U.S. and Canada) have collaborated since 2018 for the co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with pembrolizumab. Through the LEAP clinical program, the companies are evaluating combination therapies across gynecologic, renal, and gastrointestinal cancers. This partnership strengthens Eisai’s global oncology footprint, commercial reach, and R&D pipeline, while advancing innovative treatments for patients worldwide.
Patients’ Significance
For patients with advanced endometrial or renal cell carcinoma, five-year survival and follow-up analyses provide crucial guidance for treatment decisions. Lenvatinib plus pembrolizumab demonstrates durable clinical benefit, tolerable safety, and the potential to improve overall survival, supporting informed therapy selection. Pipeline therapies, including E7386, offer hope for patients who have progressed on standard therapies, reflecting Eisai’s dedication to improving both survival and quality of life.
Policy Significance
Eisai’s human health care (hhc) concept underscores the reduction of health disparities and improved access to innovative oncology therapies. By targeting cancers with high unmet need and advancing novel immunotherapy combinations, Eisai contributes to global health policy objectives and UN Sustainable Development Goals, including elimination of neglected tropical diseases (NTDs). Eisai’s transparent, regulatory-compliant clinical programs reinforce public confidence in novel treatments and policy-aligned innovation.
Transaction Highlights
At ESMO 2025, Eisai will present five-year outcomes from Study 309/KEYNOTE-775 on lenvatinib plus pembrolizumab in advanced endometrial carcinoma (Poster #1119P). The LEAP-001 study will share additional one-year follow-up results for first-line therapy in advanced or recurrent endometrial cancer (Poster #1114P), along with a combined analysis of post-(neo)adjuvant therapy outcomes (Poster #1124P). In renal cell carcinoma, the CLEAR study will report final analysis data for lenvatinib plus pembrolizumab versus sunitinib, including patients with bone metastases (Poster #2603P). Eisai’s pipeline candidate E7386 will be evaluated in Study 102 for advanced or recurrent endometrial carcinoma (Poster #1153P). Additionally, the LEAP-014 study will present results in metastatic esophageal squamous cell carcinoma (Proffered Paper #LBA79), highlighting Eisai’s broad clinical research across multiple cancers.
Source: Eisai Inc. Press Release
