No.24-05

January 16, 2024
Eisai Co., Ltd.

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

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the presentation ofoncology 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) andcholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) GastrointestinalCancers 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 evaluatingtasurgratinib (formerly E7090) as a treatment for patients with fibroblast growth factor receptor 2 (FGFR2)
gene fusion positive cholangiocarcinoma (NCT04238715; Abstract: #471). Tasurgratinib, for which amarketing 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, incombination 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®), theorally 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 TypeStudy/Compound Abstract Title

Abstract Type & Details(Pacific Standard Time)

Pipeline
Gastrointestinal
Cancer

E7090

Pivotal single-arm, phase 2 trial of
Poster Session
tasurgratinib for patients with
Abstract #471
fibroblast growth factor receptor-2
January 19, 2024
gene fusion-positive
12:30-2:00 PM
cholangiocarcinoma

Gastrointestinal
Cancer

E7386

Analysis of tumor biomarkers inpatients with advanced
Poster Session
hepatocellular carcinoma from a
Abstract #535
phase 1b study of E7386, aJanuary 19, 2024
CREB-binding protein/β-catenin
12:30-2:00 PMinteraction inhibitor, in combination
with lenvatinib

Lenvatinib Plus Pembrolizumab

GastrointestinalCancer

LEAP-002

Lenvatinib plus pembrolizumab
versus lenvatinib alone as first-line Poster Session
therapy for advanced
Abstract #482
hepatocellular carcinoma: longer- January 19, 2024
term efficacy and safety results
12:30-2:00 PM
from the phase 3 LEAP-002 study

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 evaluatedlenvatinib 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 otherfirst-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 afirst-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 realworld 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 madeavailable 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

Genitourinary
CancerNetwork MetaAnalysis

Genitourinary
Cancer

KEYNOTE-B61

Rapid Oral Abstract
Subgroup analyses of efficacy
Sessionoutcomes by baseline tumor size
Abstract #364
in the phase 3, open‐label CLEAR
January 27, 2024
trial
1:00-2:15 PM
Network meta-analysis to assesscomparative efficacy of lenvatinib Poster Session
plus pembrolizumab compared
Abstract #482
with other first-line treatments for January 27, 2024
management of advanced renal
7:00 AM
cell carcinoma
First-line pembrolizumab plus
lenvatinib for non-clear cell renal Poster Session
carcinomas: Extended follow-up of Abstract #2
the Phase 2 KEYNOTE-B61 Study January 27, 2024
(Presented by Merck & Co., Inc., 7:00 AM
Rahway, NJ, USA)

Lenvatinib Plus Everolimus
GenitourinaryCancer

Real World
Evidence

Lenvatinib plus everolimus in
Poster Session
patients with pre-treated advanced Abstract #437
renal cell carcinoma: Real world January 27, 2024
evidence
7:00AMIn March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the UnitedStates and Canada), through an affiliate, entered into a strategic collaboration for the worldwide codevelopment and co-commercialization of lenvatinib, both as monotherapy and in combination with theanti-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 anddevelopment 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 todiscover innovative new drugs with new targets and mechanisms of action from these domains, with the aim ofcontributing 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.

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