No.23-08

January 18, 2023
Eisai Co., Ltd.

EISAI AIMS TO ADVANCE GASTROINTESTINAL CANCER TREATMENT WITH RESEARCHACROSS MULTIPLE TUMOR TYPES AT ASCO GI 2023
Highlights Include an Update from the Dose Escalation Part of a Phase 1 Study Evaluating
the Novel Anticancer Agent, E7386, in Advanced Solid Tumors Including Colorectal Cancer
Research from the LEAP (LEnvatinib And Pembrolizumab) Clinical Program May Provide
New Information About Treating Patients with Unresectable Hepatocellular Carcinoma
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the presentation ofresearch across various types of gastrointestinal cancers during the 2023 American Society of ClinicalOncology (ASCO) Gastrointestinal Cancers Symposium (#GI23), which is taking place in-person in San
Francisco, California and virtually from January 19-21.
Notable data include an update from the dose-escalation part of a Phase 1 Study evaluating E7386*1, a
CREB-binding protein (CBP) / β-catenin interaction inhibitor, in patients with advanced solid tumors
including colorectal cancer (NCT03833700; Abstract: #106). Based on these additional analyses, furtherinvestigation of safety, preliminary efficacy, pharmacokinetics and biomarker analyses of E7386 is ongoing
using two dose levels in the expansion part.
Research from the LEAP (LEnvatinib And Pembrolizumab) clinical program includes a poster presentation
featuring a health-related quality of life analysis from the Phase 3 LEAP-002 trial investigating the lenvatinib(LENVIMA®) plus pembrolizumab (KEYTRUDA®*2) combination versus lenvatinib plus placebo as a firstline treatment for patients with unresectable hepatocellular carcinoma (NCT03713593; Abstract: #506).
Additional presentations on Eisai’s oncology pipeline showcase Eisai’s investigational compound, E7389LF, a new liposomal formulation of eribulin, in combination with nivolumab in patients with solid tumors.
Efficacy and safety were evaluated in expansion cohorts, including an esophageal cancer cohort(NCT04078295; Abstract: #337) and a gastric cancer cohort (NCT04078295; Abstract: #339).
“We are eager to share new data at the annual symposium where specialists in gastrointestinal cancers
gather from all over the world, including findings from a Phase 1 study evaluating the novel investigational
anticancer agent, E7386, in advanced solid tumors including colorectal cancer,” said Dr. Takashi Owa,Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. “Our findings across colorectal, esophageal,
gastric and liver cancer illustrate Eisai’s commitment to further oncology research for people living withgastrointestinal cancers, who account for over one quarter of the global cancer incidence 1.”
In March 2018, Eisai and Merck (known as MSD outside the United States and Canada), through anaffiliate, entered into a strategic collaboration for the worldwide co-development and co-commercializationof lenvatinib, both as monotherapy and in combination with Merck’s anti-PD-1 therapy pembrolizumab. Todate, more than 10 trials have been initiated under the LEAP clinical program, which is evaluating thecombination across multiple tumor types.
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. The majority of abstracts are currently available on
the ASCO website. The late-breaking abstracts will be released at the time of presentation during thesymposium.
Cancer Type

Study/
CompoundAbstract Title

Abstract Type &Details(Pacific Standard Time)

Pipeline

Solid Tumors

Poster Presentation
Abstract #106
January 21, 2023
6:30-7:55 AM

E7386

A phase 1 study of E7386, a CREB-binding
protein (CBP)/β-catenin interaction inhibitor,in patients (pts) with advanced solid tumors
including colorectal cancer: updated doseescalation partE7389-LF

Gastric cancer (GC) cohort of a phase 2 trialof E7389-LF (liposomal formulation oferibulin) in combination with nivolumab

Poster Presentation
Abstract #339
January 19, 2023
12:00-1:30 PME7389-LF

The esophageal cancer cohort of a phase 2
trial of E7389‐LF (liposomal formulation oferibulin) + nivolumab

Poster Presentation
Abstract #337
January 19, 2023
12:00-1:30 PM

LEAP clinical program

LEAP-015

First-line lenvatinib plus pembrolizumab plus
chemotherapy versus chemotherapy inadvanced/metastatic gastroesophageal
adenocarcinoma: (LEAP-015): Safety run-in
results (Encore presentation)

Poster Presentation
Abstract #411
January 19, 2023
12:00-1:30 PMLEAP-002

Health-related quality of life (HRQoL) impactof lenvatinib (len) plus pembrolizumab(pembro) versus len plus placebo (pbo) as
first-line (1L) therapy for advanced
hepatocellular carcinoma (aHCC): Phase 3
LEAP-002 study

Poster Presentation
Abstract #506
January 20, 2023
12:00-1:30 PM

Prevalence of historical medical conditionsor comorbidities with potential role in clinicaldecision making related to suitability of
immuno-oncologic plus IV antiangiogenic
therapy in newly diagnosed first-line
unresectable hepatocellular carcinoma in theUnited States

Poster Presentation
Presentation #511
January 20, 2023
12:00-1:30 PM

Gastrointestinal
Cancers

Real World Evidence

Gastrointestinal
CancerReal-worlddata

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120[Notes to editors]
1. Eisai’s Focus on Cancer
Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience andknowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing(leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim
to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanismsof action from these Ricchi, 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.
1.

Melina A. et al. Global Burden of 5 Major Types of Gastrointestinal Cancer. Gastroenterology. 2020 July; 159(1): 335–349.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8630546/pdf/nihms-1758791.pdf###