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Eisai Furthers Oncology Research Across Multiple Cancers at ASCO GI and ASCO GU 2024

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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually. First, the company will share findings in hepatocellular carcinoma (HCC) and cholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI24), which is taking place from January 18-20. Eisai will also present research results in renal cell carcinoma (RCC) during the 2024 ASCO Genitourinary Cancers Symposium (#GU24), which is taking place from January 25-27.

Key Data from Eisai’s Pipeline and Portfolio to be Presented at ASCO GI 2024
Notable findings from Eisai’s pipeline include results from a single-arm Phase 2 trial evaluating tasurgratinib (formerly E7090) as a treatment for patients with fibroblast growth factor receptor 2 (FGFR2) gene fusion positive cholangiocarcinoma (NCT04238715; Abstract: #471). Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective tyrosine kinase inhibitor of FGFR1-3. An analysis of tumor biomarkers in patients with advanced HCC from a Phase 1b study of E7386*1, a CREB-binding protein (CBP) / β-catenin interaction inhibitor, in combination with lenvatinib, will also be presented (NCT04008797; Abstract: #535).

Additional data from the LEAP (LEnvatinib And Pembrolizumab) clinical program include longer term efficacy and safety results from the Phase 3 LEAP-002 trial, which evaluated lenvatinib (LENVIMA®), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus pembrolizumab (KEYTRUDA®*2), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, versus lenvatinib monotherapy as a first-line treatment for patients with unresectable HCC (NCT03713593; Abstract: #482).

The list of notable ASCO GI 2024 presentations is included below. These abstracts will be made available via the ASCO website on Tuesday, January 16, 2024, at 2:00 PM PST.

ASCO GI 2024
Cancer Type Study/Compound Abstract Title Abstract Type & Details
(Pacific Standard Time)
Pipeline
Gastrointestinal Cancer E7090 Pivotal single-arm, phase 2 trial of tasurgratinib for patients with fibroblast growth factor receptor-2 gene fusion-positive cholangiocarcinoma

Poster Session
Abstract #471
January 19, 2024
12:30-2:00 PM
E7386 Analysis of tumor biomarkers in patients with advanced hepatocellular carcinoma from a phase 1b study of E7386, a CREB-binding protein/β-catenin interaction inhibitor, in combination with lenvatinib

Poster Session
Abstract #535
January 19, 2024
12:30-2:00 PM
Lenvatinib Plus Pembrolizumab
Gastrointestinal Cancer LEAP-002 Lenvatinib plus pembrolizumab versus lenvatinib alone as first-line therapy for advanced hepatocellular carcinoma: longer-term efficacy and safety results from the phase 3 LEAP-002 study

Poster Session
Abstract #482
January 19, 2024
12:30-2:00 PM

 

Key Data from Eisai’s Pipeline and Portfolio to be Presented at ASCO GU 2024
Subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib plus pembrolizumab versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (aRCC), will be featured in a rapid oral abstract session (NCT02811861; Abstract: #364) and a network meta-analysis to assess the efficacy of lenvatinib plus pembrolizumab compared with other first-line treatment options for patients with aRCC will also be presented in a poster session (Abstract: #482). Extended follow-up results from the Phase 2 KEYNOTE-B61 trial evaluating the combination as a first-line treatment for patients with non-clear cell RCC will be shared in a poster presentation (NCT04704219; Abstract: #2) by Merck & Co., Inc., Rahway, NJ, USA. Finally, a poster featuring real-world evidence on the use of lenvatinib plus everolimus in previously treated patients with aRCC (Abstract: #437) will also be presented.

The list of notable ASCO GU 2024 presentations is included below. These abstracts will be made available via the ASCO website on Monday, January 22, 2024, at 2:00 PM PST.

ASCO GU 2024
Cancer Type Study/Compound Abstract Title Abstract Type & Details
(Pacific Standard Time)
Lenvatinib Plus Pembrolizumab
Genitourinary Cancer CLEAR Subgroup analyses of efficacy outcomes by baseline tumor size in the phase 3, open‐label CLEAR trial

Rapid Oral Abstract Session
Abstract #364
January 27, 2024
1:00-2:15 PM
Network Meta-Analysis Network meta-analysis to assess comparative efficacy of lenvatinib plus pembrolizumab compared with other first-line treatments for management of advanced renal cell carcinoma

Poster Session
Abstract #482
January 27, 2024
7:00 AM
KEYNOTE-B61 First-line pembrolizumab plus lenvatinib for non-clear cell renal carcinomas: Extended follow-up of the Phase 2 KEYNOTE-B61 Study

(Presented by Merck & Co., Inc., Rahway, NJ, USA)

Poster Session
Abstract #2
January 27, 2024
7:00 AM
Lenvatinib Plus Everolimus
Genitourinary Cancer Real World Evidence Lenvatinib plus everolimus in patients with pre-treated advanced renal cell carcinoma: Real world evidence

Poster Session
Abstract #437
January 27, 2024
7:00AM

 

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), 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 Merck & Co., Inc., Rahway, NJ, USA, pembrolizumab. Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across multiple clinical trials.

This release discusses investigational compounds and investigational uses for Food and Drug Administration (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.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

[Notes to editors]
1. Eisai’s Focus on Cancer
Eisai acknowledges “Oncology” as one of its key strategic areas, and will continue to focus on the discovery and development of anti-cancer drugs within drug discovery domains including “microenvironment”, “proteostasis disruption”, “cell lineage and cell differentiation”, and “inflammation, hypoxia, oxidative stress and cell senescence” under the Deep Human Biology Learning (DHBL) drug discovery and development organization. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.

*1 E7386 is created through collaboration research between Eisai and PRISM BioLab Co., Ltd. (Headquarters: Kanagawa)
*2 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, N.J., U.S.A.

Our Values

Values are an integral part of our foundation. With every decision, we ensure that we follow:

Integrity

Integrity is the living up to legal, moral and ethical principles in the conduct of HI-Eisai Pharmaceutical Inc. business. It means that each employee embodies the value of integrity, and therefore represents the company in honesty and rectitude in all the ways they do their work.

It is expected that each employee would make decisions guided by good judgement, not just for one‘s self, but for HI-Eisai as the company. An employee who acts with integrity ensures that he has understanding of the principles by which the company operates, and in situations where he lacks clarity, will actively seek guidance.

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The company is committed to ensure that it maintains a safe, inclusive, and healthy working environment that promotes productivity among employees. All employees are expected to show respect to fellow employees, customers, and patients, regardless of differences in gender, culture, backgrounds, and beliefs. Leaders in the organization are likewise expected to promote inclusivity with their teams, and shall not tolerate any discriminatory and offensive actions.

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Accountability at work means assuming responsibility for the business outcome and how that is achieved. It means that every employee, in whichever position, are equally responsible for the decisions and actions they make for the company. It is likewise, the responsibility of each employee to report, any knowledge of misconduct or potential violation to the company‘s rules and regulations.

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At the heart of the company‘s operation are the patients. This means that every decision to be made, considers the potential impact and benefit to the patients. As such, the company commits itself in ensuring that business objectives align with its principle of human health care or hhc. The programs created and implemented are based on how well they could contribute to improving patients‘ lives.

For field-based employees, being patient-centric means that the focus of engagements with customers are on understanding patient needs as well as providing these stakeholders with comprehensive information on how HI-Eisai‘s products can support their patients goals.

For each employee, being patient-centric means taking on their responsibilities with care and consideration on how it impacts the patients experience, be it by making relevant information readily available for the doctors; or by ensuring access and availability to the medicines we offer.

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As a patient-centric company, we define Excellence by the outstanding quality of our work to improve patients‘ lives. Each employee is expected to consistently demonstrate work ethics that align to our values, policies, and our desire to provide above standard service. The company is committed in ensuring that all actions are in compliance with legal requirements.

Being excellent means that every employee passionately strives to be better and participates in the company‘s initiatives to develop their members in terms of knowledge, skills, and behavior, which will support a continuously improving, responsible and performance-driven workforce.

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Our Mission

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