Here is a professional English translation of the Chinese title: **Eisai to Present Additional Clinical Data for Lenvima® (Lenvatinib) in Approved Indications at the 2026 American Society of Clinical Oncology Annual Meeting (ASCO 2026)**

TokyoJune 1, 2026 /PRNewswire/ — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, hereinafter “Eisai”) recently announced that it will present multiple clinical research results from its marketed oncology products and pipeline at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO26), held both in person and virtually from May 29 to June 2 in Chicago, Illinois, USA.

Key data includes results from a real-world study analysis comparing the efficacy of first-line use of Eisai’s self-developed oral multi-targeted tyrosine kinase inhibitor (TKI) lenvatinib (Lenvima®) versus dabrafenib (BRAF inhibitor) combined with trametinib (MEK inhibitor) in patients with BRAF-mutated differentiated thyroid cancer (DTC). This poster presentation will share real-world clinical practice data, providing reference for treatment selection in this genetically stratified DTC patient population (Abstract #6052). Currently, the National Comprehensive Cancer Network® (NCCN®)*1 Clinical Practice Guidelines for Thyroid Cancer list lenvatinib as a preferred first-line category 1 systemic therapy option for progressive radioactive iodine-refractory differentiated thyroid cancer.

“Supported by over a decade of clinical and real-world evidence, lenvatinib continues to play an important role in the treatment of refractory cancers,” said Dr. Corina Dutcus, Senior Vice President of Global Clinical Development, Oncology at Eisai. “At ASCO 2026, Eisai will present new research that further solidifies this foundation and enriches the clinical evidence for lenvatinib in its approved indications, providing valuable insights for clinical practice. This study, along with our ongoing pipeline development, reflects part of our human health care commitment to supporting the people we serve.”

Other studies from Eisai’s pipeline include an online publication highlighting an analysis from a Phase I trial evaluating E7386*3, a CREB-binding protein (CBP)/β-catenin interaction inhibitor. This analysis aims to provide reference for cardiac safety assessment in early oncology development (Abstract #e24005).

This press release discusses investigational uses of trial compounds and FDA-approved products, and does not draw conclusions regarding efficacy or safety. There is no guarantee that any investigational use of trial compounds or FDA-approved products will successfully complete clinical development or gain FDA approval.

Eisai’s complete presentation lineup is as follows. These abstracts were released via the ASCO website on Thursday, May 21, 2026, at 5:00 PM EDT.

Cancer Type

Study /
Compound

Abstract Title

Abstract Type & Details

Lenvatinib

Thyroid Cancer

Real-World
Study

First-Line Lenvatinib vs. Dabrafenib
+ Trametinib (D+T) in BRAF-
Mutated Differentiated Thyroid
Cancer (DTC): Insights from Real-
World Data

Poster Session

Abstract #6052

May 30, 2026

2:30-5:30 PM EDT / 1:30-

4:30 PM CDT

Lenvatinib + Pembrolizumab

Genitourinary
Cancer

CLEAR Trial

Efficacy Outcomes by Progression
Pattern in Patients with Advanced
Renal Cell Carcinoma from the
Phase III CLEAR Trial

Poster Session

Abstract #4527

May 31, 2026

10:00 AM-1:00 PM EDT /

9:00 AM-12:00 PM CDT

Pipeline

Pan-Tumor

E7386

Cardiac Safety Assessment Using
Phase I Trial Data of E7386: Informing
Early Oncology Development via
Concentration-QTc Relationship
Analysis

Online Publication

Abstract #E24005

The following presentations include studies sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, utilizing lenvatinib.

Cancer Type

Study

Abstract Title

Abstract Type & Details

Lung Cancer

KEYNOTE
-495/KeyIm
PaCT

Biomarker-Directed Randomized
Phase II KEYNOTE-495/KeyImPaCT
Study: Final Analysis of
Pembrolizumab (P)-Based
Combination Regimens in Non-Small
Cell Lung Cancer (NSCLC)

Poster Session

Abstract #8584

May 31, 2026

10:00 AM-1:00 PM EDT /

9:00 AM-12:00 PM CDT

Genitourinary
Cancer

KEYNOTE
-365

Phase Ib/II Study of Pembrolizumab
Plus Lenvatinib, or Pembrolizumab
Plus Co-Formulation with
Vibostolimab, in Patients with
Metastatic Neuroendocrine Prostate
Cancer (NEPC): KEYNOTE-365
Cohorts F and H

Poster Session

Abstract #5055

May 31, 2026

10:00 AM-1:00 PM EDT /

9:00 AM-12:00 PM CDT

In March 2018, Eisai entered into a strategic collaboration agreement with Merck Sharp & Dohme LLC, through its affiliate, for the global co-development and co-commercialization of lenvatinib, including as monotherapy and in combination with Merck’s PD-1 inhibitor pembrolizumab. In the United States, the European Union, Japan, and other countries/regions, KEYTRUDA in combination with LENVIMA is approved for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma. Lenvatinib is approved under the brand name KISPLYX® in the European Union for the treatment of advanced RCC.

The following report includes a study sponsored by Nuvation Bio Inc. (Headquarters: New York, hereinafter “Nuvation Bio”) on taletrectinib.

Cancer Type

Study Name

Abstract Title

Abstract Type & Details

Lung Cancer

TRUST-II

Patient-Reported Outcomes (PROs)
and Health-Related Quality of Life
(HRQoL) from the TRUST-II Study of
Taletrectinib in Patients with
Advanced ROS1-Positive Non-Small
Cell Lung Cancer (NSCLC)

Poster Session

Abstract #8629

May 31, 2026

10:00 AM-1:00 PM EDT /

9:00 AM-12:00 PM CDT

In January 2026, we obtained exclusive rights from Nuvation Bio to develop, register, and commercialize taletrectinib in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam, and India. Taletrectinib is a next-generation ROS1 inhibitor for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). Following the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in March 2026, the application was validated and entered the standard review process. Subsequent filings are planned in the United Kingdom, Canada, and other territories authorized by Eisai.

The following report includes a study sponsored by Shanghai Henlius Biotech, Inc. (Headquarters: Shanghai, hereinafter “Henlius”) on serplulimab.

Cancer Type

Compound

Abstract Title

Abstract Type & Details

Gastric Cancer

Serplulimab

Neoadjuvant/Adjuvant Serplulimab
Plus Chemotherapy vs. Placebo Plus
Chemotherapy in PD-L1-Positive
Gastric Cancer: A Randomized,
Double-Blind, Multicenter Phase III
Study

Rapid Oral Abstract Session

Abstract #4009

June 1, 2026

2:15 PM-2:21 PM EDT/

1:15 PM-1:21 PM CDT

In February 2026, we obtained exclusive rights from Henlius to commercialize serplulimab, a novel anti-PD-1 monoclonal antibody, in Japan. In Japan, Henlius is currently conducting a Phase II bridging clinical trial for extensive-stage small cell lung cancer (ES-SCLC) and plans to submit a marketing authorization application during Eisai’s fiscal year 2026, based on the results of this trial and Phase III clinical trial data supporting the approval of this indication in China and Europe.

(Editor’s Note)

1. Eisai’s Focus in Oncology

Eisai has designated oncology as a key strategic area, aiming to contribute to the cure of cancer by discovering innovative drugs with new targets and mechanisms of action through its Deep Human Biology Learning (DHBL) drug discovery system.

By utilizing biomarker data obtained from our products to analyze cancer pathogenesis, underlying causes, and resistance mechanisms, and leveraging the group’s precision chemistry technologies, we aim to transform undruggable therapeutic targets into druggable ones, creating new core therapeutic drugs.

*1 NCCN makes no warranties of any kind whatsoever regarding its content, use or application, and disclaims any responsibility for its application or use in any way.
*2 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
*3 E7386 is being developed in collaboration with PRISM BioLab Co., Ltd. (Headquarters: Kanagawa).

 

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