On October 1, 2025 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of clinical research across its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, which is taking place in Berlin, Germany from October 17 to 21 (Press release, Eisai, OCT 1, 2025, View Source [SID1234656400]).

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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 (Free ESMO Whitepaper) 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 LEAP001 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 (Free ESMO Whitepaper) website on 12:05 AM Central European Summer Time (CEST) on Monday, October 13, 2025. Latebreaking abstracts accepted for presentation at ESMO (Free ESMO Whitepaper) as a Proffered Paper or Mini Oral will be published on the ESMO (Free ESMO Whitepaper) 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.

Cancer Type Study/Compound Presentation Title Presentation Type & Details
Lenvatinib Plus Pembrolizumab
Gynecologic Cancer
Study 309/
KEYNOTE-775
Lenvatinib plus pembrolizumab (L+P) vs
treatment of physician’s choice (TPC) for
advanced endometrial cancer (EC): 5-Year
outcomes from Study 309/KEYNOTE-775
Poster Session
Presentation #1119P
October 18, 2025
LEAP-001
First-line lenvatinib + pembrolizumab (L+P) vs
chemotherapy (CT) for advanced or recurrent
endometrial cancer (EC): additional 1-year
follow-up results from ENGOT-en9/LEAP-001
Poster Session
Presentation #1114P
October 18, 2025
Study 309/
KEYNOTE-775 and
LEAP-001
Lenvatinib + pembrolizumab (L+P) in participants
(Pts) with advanced or recurrent endometrial
cancer (aEC): Study 309/KEYNOTE-775 and
ENGOT-en9/LEAP-001 post-(neo)adjuvant
therapy outcomes
Poster Session
Presentation #1124P
October 18, 2025
Gastrointestinal Cancer LEAP-014
Lenvatinib plus pembrolizumab and
chemotherapy versus pembrolizumab and
chemotherapy in untreated metastatic
esophageal squamous cell carcinoma: the
randomized Phase 3 LEAP-014 Study
Proffered Paper Session
Presentation #LBA79
October 17, 2025
2:40-2:50 PM
Genitourinary Cancer CLEAR
Final analysis of lenvatinib + pembrolizumab
(L+P) vs sunitinib (S) in patients with advanced
renal cell carcinoma (aRCC) with or without bone
metastases in CLEAR
Poster Session
Presentation #2603P
October 18, 2025
Pipeline
Gynecologic Cancer E7386*2
Clinical and biomarker results from E7386 study
102: global dose-expansion cohort of E7386 +
lenvatinib (LEN) in patients (pts) with
advanced/recurrent endometrial cancer (aEC)
that progressed on platinum-based
chemotherapy (PBC) and an anti-PD-(L)1
immunotherapy (IO)
Poster Session
Presentation #1153P
October 18, 2025
The following presentations represent studies including lenvatinib treatment sponsored by MSD.
Cancer Type Study/Compound Presentation Title Presentation Type & Details
Genitourinary Cancer
LITESPARK-010
Belzutifan plus lenvatinib for Chinese participants
(pts) with previously treated advanced clear cell
renal cell carcinoma (ccRCC): updated results of
cohort 1 of the LITESPARK-010 study
Poster Session
Presentation #2615P
October 18, 2025
KEYMAKER-U03A
First-line pembrolizumab-based regimens for
advanced clear cell renal cell carcinoma:
KEYMAKER-U03 substudy 03A
Proffered Paper Session
Presentation #LBA96
October 18, 2025
8:30-8:40 AM
Melanoma KEYMAKER-U02B
First-line pembrolizumab alone or with
investigational agents for advanced melanoma:
updated results from the phase 1/2 KEYMAKERU02 substudy 02B
Poster Session
Presentation #1621P
October 20, 2025

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.