Eisai Highlights Breadth of Oncology Research at ESMO 2025

• For Print
• October 2, 2025

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the presentation of clinical research across its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2025, which is taking place in Berlin, Germany from October 17 to 21.

Among the notable presentations is data from the Phase 3 Study 309/KEYNOTE-775 trial, which evaluated lenvatinib (LENVIMA^®), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA^®*1), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy versus treatment of physician's choice for patients with advanced endometrial carcinoma. The presentation will feature 5-year overall survival data providing deeper insights into long-term treatment for patients affected by this disease (NCT03517449; Abstract #1119P).

"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 and underscoring Eisai's commitment to generating the long-term evidence that patients, families, and healthcare providers rely on to make informed treatment decisions," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. "Our research in endometrial cancer, alongside our data in renal cell carcinoma and innovative pipeline approaches, reflects our dedication to our human health care concept to address unmet medical needs and advance treatment options for people living with cancer."

Further endometrial cancer research includes additional 1-year follow-up results from the Phase 3 LEAP-001 study in first-line advanced or recurrent endometrial carcinoma (NCT03884101; Abstract #1114P), as well as a combined analysis examining post-(neo)adjuvant therapy outcomes from both the Study 309/KEYNOTE-775 and LEAP-001 studies (Abstract #1124P). 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).

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).

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. Regular abstracts will be made available via the ESMO website on 12:05 AM Central European Summer Time (CEST) on Monday, October 13, 2025. Late-breaking abstracts accepted for presentation at ESMO as a Proffered Paper or Mini Oral will be published on the ESMO website at 12:05 AM CEST on the day of presentation. Posters will be on display from 9:00 AM – 5:00 PM CEST on the day of their poster session.

　The following presentations represent studies including lenvatinib treatment sponsored by MSD.

In March 2018, Eisai and MSD, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy from MSD, pembrolizumab. Eisai and MSD are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program. Lenvatinib plus pembrolizumab is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC and certain types of advanced endometrial carcinoma. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.  

Media Inquiries:

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Eisai Co., Ltd.

+81-(0)3-3817-5120

[Notes to Editors]

1. Eisai’s Focus on Cancer

Eisai positions Oncology as one of its key strategic areas, and aims to contribute to the cure of cancers through the discovery of innovative new drugs with new targets and mechanisms of action under the Deep Human Biology Learning (DHBL) drug discovery and development organization. 

By utilizing biomarker data obtained from our products to elucidate the mechanisms of the incidence and root causes of cancer, as well as drug resistance, and using Eisai Group's precision chemistry technology to turn undruggable intracellular therapeutic targets into druggable ones, we will create new backbone therapeutic drugs.

*1 KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

*2 E7386 is created through collaboration research between Eisai and PRISM BioLab Co., Ltd. (Headquarters: Kanagawa)

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