No.23-37

May 24, 2023
Eisai Co., Ltd.

EISAI DELIVERS NEW DATA AND HIGHLIGHTS CONTINUED PROGRESS OF ONCOLOGYPORTFOLIO AND PIPELINE AT ASCO 2023

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the presentation ofresearch across various types of cancer from its oncology portfolio and pipeline during the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO23), which is taking place virtually and inperson in Chicago, Illinois from June 2 to 6.
Notable research includes an oral presentation of results from the final pre-specified overall survival
analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib(LENVIMA®) plus pembrolizumab (KEYTRUDA®) versus sunitinib for the first-line treatment of patients withadvanced renal cell carcinoma (Abstract #4502). A post hoc analysis from the REFLECT trial evaluating
lenvatinib monotherapy versus sorafenib in the first-line treatment of patients with unresectable
hepatocellular carcinoma (HCC) will also be shared in a poster presentation (Abstract #4078).
“The outlook for advanced renal cell carcinoma has evolved in recent years, and the final analysis fromthe pivotal CLEAR trial to be presented at ASCO represents another step forward for patients and anopportunity to provide their physicians with long-term data,” said Dr. Takashi Owa, Chief Scientific Officer,
Senior Vice President, Eisai Co., Ltd. “New data for lenvatinib and from our oncology pipeline showcase
Eisai’s continued commitment to driving innovation and exploring novel therapeutic modalities in ourambition to live out our human health care concept, our corporate mission to meet the needs of more
people who face a cancer diagnosis.”
Additional data from Eisai’s pipeline include a poster presentation of findings from a phase 1b study ofE7386, a CREB-binding protein (CBP) / β-catenin interaction inhibitor, in combination with lenvatinib inpatients with advanced HCC (Abstract #4075), and the small cell lung cancer cohort of a phase 1b/2 trial
evaluating E7389-LF, a new liposomal formulation of eribulin, in combination with nivolumab (Abstract#8593). Insights from preclinical testing of farletuzumab ecteribulin (FZEC), formerly known as MORAb202, and MORAb-109, antibody drug conjugates (ADC), in rare gynecologic cancers will also be published
online (Abstract # e17634).
Furthermore, Bliss Biopharmaceutical Co., Ltd. (BlissBio) will present a poster at the conference withresults from the first-in-human study of BB-1701, a HER2-targeting ADC (Abstract #3029). Eisai enteredinto a joint development agreement with BlissBio for BB-1701 with option rights for a strategic collaborationin April 2023. A Phase 1/2 clinical study of BB-1701 in the U.S. and China for HER2-expressing solidtumors is currently underway.
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 presentations is included below. These abstracts will be made available on Thursday, May
25, 2023 at 4:00 PM Central Daylight Time (CDT).
Cancer Type

Study/Compound Abstract Title

Abstract Type &Details

Lenvatinib Plus Pembrolizumab
Final prespecified overall survival (OS) analysis of
Genitourinary Cancer CLEAR

CLEAR: 4-year follow-up of lenvatinib plus
pembrolizumab (L+P) vs sunitinib (S) in patients(pts) with advanced renal cell carcinoma (aRCC)

Oral Abstract
Session
Abstract #4502
June 5, 2023
11:54 AM CDT

Lenvatinib
Efficacy of lenvatinib (LEN) vs sorafenib (SOR) in
Gastrointestinal
Cancerthe first-line (1L) treatment of patients (pts) withREFLECT

unresectable hepatocellular carcinoma (uHCC): A
post hoc analysis of patients with nonviral etiology
from REFLECT

Poster Session
Abstract #4078
June 5, 2023
8:00 AM CDT

Pipeline
Phase 2 small cell lung cancer (SCLC) cohort of aLung Cancer

E7389-LF

phase 1b/2 trial of a liposomal formulation of eribulin
in combination with nivolumab

Poster Session
Abstract #8593
June 4, 2023
8:00 AM CDT

A phase 1b study of E7386, a CREB-binding protein Poster Session
Gastrointestinal

E7386 (plus(CBP)/β-catenin interaction inhibitor, in combination Abstract #4075

Cancerslenvatinib)

with lenvatinib in patients with advanced

June 5, 2023

hepatocellular carcinoma

8:00 AM CDT

Farletuzumab
Gynecologic Cancer

Ecteribulin(FZEC)

Preclinical testing of farletuzumab ecteribulin (FZEC Online Publication[MORAb-202]) and MORAb-109, folate receptor α

Abstract #e17634
and mesothelin targeting antibody-drug conjugates May 25, 2023
4:00 PM CDT(ADCs), in rare gynecologic cancers
A first-in-human, open label, multiple dose, dose

BB-1701
Solid tumors(Presented byBlissBio)

escalation, and cohort expansion phase 1 study toPoster Session

investigate the safety, tolerability, pharmacokinetics Abstract #3029
and antitumor activity of BB-1701 in patients with

June 3, 2023

locally advanced/metastatic HER2-expressing solid 8:00 AM CDTtumors

Additional ResearchAnti-drug antibodies related to CTLA-4, PD-1 or PDPan-tumor

Systematic review L1 inhibitors across tumour types: A systematicreview

Online Publication
Abstract #e14600
May 25, 2023
4:00 PM CDT

In 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 withMerck’s anti-PD-1 therapy pembrolizumab. Eisai and Merck are studying the LENVIMA plus KEYTRUDA
combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types
across more than multiple clinical trials.
In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaborationagreement for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC, formerly
known as MORAb-202), a folate receptor alpha (FRα)-targeting ADC. Eisai and Bristol Myers Squibb are
currently investigating FZEC in multiple studies including: a Phase 1/2 clinical study in the United Statesand Europe for solid tumors including endometrial cancer, a Phase 2 clinical study in the United Statesand Europe for non-small cell lung cancer, and a Phase 2 clinical study in Japan, the United States andEurope for ovarian cancer, peritoneal cancer and fallopian tube cancer.
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 “tumor microenvironment”, “proteostasisdisruption”, “cell linage 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.
* KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway,NJ, USA.

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