No.24-35

May 23, 2024
Eisai Co., Ltd.

EISAI SHOWCASES ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2024
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the presentation ofresearch across multiple types of cancer from its oncology portfolio and pipeline during the 2024 American
Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO24), which is taking place virtually and inperson in Chicago, Illinois from May 31 to June 4.
Notable data includes an oral presentation on biomarker analyses from the pivotal Phase 3 CLEAR (Study307)/KEYNOTE-581 trial (NCT02811861), which evaluated lenvatinib (LENVIMA®) plus pembrolizumab(KEYTRUDA®) versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma(Abstract #4504). An analysis of patterns of disease progression and subsequent therapy from this trial
will also be presented in a poster presentation (Abstract #4524).
“At Eisai, we let the science drive us to new approaches that accelerate progress in oncology, while also
remaining grounded in our human health care concept that reinforces our commitment to prioritize theneeds of patients and families impacted by a cancer diagnosis,” said Dr. Takashi Owa, Chief ScientificOfficer, Senior Vice President, Eisai Co., Ltd. “With this in mind, we look forward to sharing research thatprovides further insight into the role of lenvatinib plus pembrolizumab as a first-line standard of care optionin advanced renal cell carcinoma, as well as research that explores various modalities in our pipeline forthe potential treatment of advanced diseases with the goal of improving patients’ lives.”
Other key research of note from Eisai’s pipeline include an oral presentation of Phase 3 data from theJBCRG-M06/EMERALD study in Japan evaluating trastuzumab and pertuzumab in combination withEisai’s eribulin mesylate or a taxane in patients with HER2-positive, locally advanced or metastatic breastcancer (NCT03264547; Abstract #1007). Additional pipeline research to be presented in poster sessions
include an overview of a Phase 2 study of BB-1701, an antibody drug conjugate targeting HER2, inpreviously treated patients with HER2-positive or HER2-low unresectable or metastatic breast cancer(NCT06188559; Abstract #TPS1122), findings from a Phase 1b trial of tasurgratinib (development code:E7090)

withor

without

endocrine

therapies

forpatientswith

ER-positive,

HER2−negative

recurrent/metastatic breast cancer after receiving a CDK4/6 inhibitor (NCT04572295; Abstract #3103), as
well as the dose-expansion part of a Phase 1b global study of E7386 in combination with lenvatinib inpatients with hepatocellular carcinoma and other solid tumors including endometrial cancer(NCT04008797; Abstract #TPS3169).
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. These abstracts will be made available via the ASCO
website on Thursday, May 23, 2024 at 4:00 PM Central Daylight Time (CDT).

Cancer Type

Study/Compound Abstract Title

Lenvatinib Plus Pembrolizumab
Genitourinary Cancer CLEAR

Genitourinary Cancer CLEAR

Melanoma

LEAP-004

Abstract Type &Details

Oral Abstract Session
Abstract #4504
June 3, 2024
9:00 AM CDT
Lenvatinib plus pembrolizumab (L+P) vs sunitinib Poster Session(S) in advanced renal cell carcinoma (aRCC):
Abstract #4524
Patterns of progression and subsequent therapy June 2, 2024
in the CLEAR trial
9:00 AM CDT
Lenvatinib (len) plus pembrolizumab (pembro) in
Poster Session
patients with advanced melanoma that
Abstract #9559
progressed on anti-PD-(L)1 therapy: Over 4
June 1, 2024years of follow-up from the phase 2 LEAP-004
1:30 PM CDT
study
Biomarker analyses in patients with advanced
renal cell carcinoma (aRCC) from the phase 3
CLEAR trial

Lenvatinib
DifferentiatedThyroid Cancer

Real-World
Evidence

Gastrointestinal
Cancer

REFLECT

Patients with radioiodine-refractory differentiated Poster Session
thyroid cancer (RAI-R DTC) with BRAF V600E Abstract #6098
and/or K601E Mutation Status – A real-world
June 2, 2024
view of effectiveness of lenvatinib monotherapy 9:00 AM CDT
ctDNA analysis of patients (pts) withPoster Session
unresectable hepatocellular carcinoma (uHCC) Abstract #4094
treated with lenvatinib (LEN) or sorafenib (SOR) June 1, 2024
as 1L therapy
1:30 PM CDTEribulin

Breast Cancer

JBCRG-M06/
EMERALD

Pipeline

BB-1701

Breast Cancer
tasurgratinib

H3B-6545

Trastuzumab and pertuzumab in combination
with eribulin mesylate or a taxane as first-line
chemotherapeutic treatment for HER2-positive,
locally advanced or metastatic breast cancer:
results of a multicenter, randomized, noninferiority phase 3 trial in Japan (JBCRGM06/EMERALD)

Oral Abstract Session
Abstract #1007
June 1, 2024
5:00 PM CDT

An open-label, multicenter, phase 2 study toevaluate the safety and efficacy of BB-1701, a
Poster Session
novel antibody drug conjugate (ADC) targeting
Abstract #TPS1122
human epidermal growth factor receptor 2June 2, 2024
(HER2), in previously treated patients with
9:00 AM CDT
HER2-positive (HER2+) or HER2-low
unresectable or metastatic breast cancer (BC)Phase Ib trial of tasurgratinib (E7090) with or
Poster Session
without endocrine therapies for patients (pts) with Abstract #3103
ER+, HER2− recurrent/metastatic breast cancer June 1, 2024
(BC) after receiving a CDK4/6 inhibitor
9:00 AM CDT
Rapid Oral Session
H3B-6545 in women with locally
Abstract #1015
advanced/metastatic estrogen receptor-positive
June 3, 2024
(ER+), HER2 negative (-) breast cancer (BC)11:30 AM CDT

H3B-6545

Solid tumors

E7386

H3B-6545 + palbociclib in patients (pts) withlocally advanced/metastatic estrogen receptorpositive (ER+), HER2 negative (-) breast cancer(BC)
Dose-expansion part of a phase 1b global studyof E7386 in combination with lenvatinib (LEN) inpatients (pts) with hepatocellular carcinoma(HCC) and other solid tumors including
endometrial cancer (EC)

Poster Session
Abstract #1051
June 2, 2024
9:00 AM CDT
Poster Session
Abstract #TPS3169
June 1, 2024
9:00 AM CDTIn 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 lenvatinib plus
pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program invarious tumor types across more than multiple clinical trials.
In May 2023, Eisai entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou)Co., Ltd. (Headquarters: Zhejiang Province, China, “BlissBio”), for BB-1701, a HER2-targeting antibody
drug conjugate (ADC), with option rights for a strategic collaboration. Eisai and BlissBio are currently
investigating BB-1701 in a Phase 2 clinical trial in Japan and the United States for breast cancer and a
Phase 1/2 clinical trial in the United States and China for HER2-expressing solid tumors.
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”, “proteostasis
disruption”, “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.
*1 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway,NJ, USA.
*2 E7386 is created through collaboration research between Eisai and PRISM BioLab Co., Ltd. (Headquarters:Kanagawa)*3 The presentation with TPS (Trial in Progress Submission) attached to the abstract number indicates that the study
is in the intermediate stage, and the presentation does not report the final study results.
###