On May 22, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across multiple types of cancer from its oncology portfolio and pipeline during the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (#ASCO24), which is taking place virtually and in-person in Chicago, Illinois from May 31 to June 4 (Press release, Eisai, MAY 22, 2024, View Source [SID1234643529]).

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Notable data includes an oral presentation on biomarker analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial (NCT02811861(New Window)), 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 the needs of patients and families impacted by a cancer diagnosis," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "With this in mind, we look forward to sharing research that provides further insight into the role of lenvatinib plus pembrolizumab as a first-line standard of care option in advanced renal cell carcinoma, as well as research that explores various modalities in our pipeline for the 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 the JBCRG-M06/EMERALD study in Japan evaluating trastuzumab and pertuzumab in combination with Eisai’s eribulin mesylate or a taxane in patients with HER2-positive, locally advanced or metastatic breast cancer (NCT03264547(New Window); 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, in previously treated patients with HER2-positive or HER2-low unresectable or metastatic breast cancer (NCT06188559(New Window); Abstract #TPS1122), findings from a Phase 1b trial of tasurgratinib (development code: E7090) with or without endocrine therapies for patients with ER-positive, HER2−negative recurrent/metastatic breast cancer after receiving a CDK4/6 inhibitor (NCT04572295(New Window); Abstract #3103), as well as the dose-expansion part of a Phase 1b global study of E7386 in combination with lenvatinib in patients with hepatocellular carcinoma and other solid tumors including endometrial cancer (NCT04008797(New Window); 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 (Free ASCO Whitepaper) website on Thursday, May 23, 2024 at 4:00 PM Central Daylight Time (CDT).

　

Cancer Type Study/Compound Abstract Title Abstract Type & Details
Lenvatinib Plus Pembrolizumab
Genitourinary Cancer CLEAR Biomarker analyses in patients with advanced renal cell carcinoma (aRCC) from the phase 3 CLEAR trial
Oral Abstract Session
Abstract #4504
June 3, 2024
9:00 AM CDT

Genitourinary Cancer CLEAR Lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in advanced renal cell carcinoma (aRCC): Patterns of progression and subsequent therapy in the CLEAR trial
Poster Session
Abstract #4524
June 2, 2024
9:00 AM CDT

Melanoma LEAP-004 Lenvatinib (len) plus pembrolizumab (pembro) in patients with advanced melanoma that progressed on anti-PD-(L)1 therapy: Over 4 years of follow-up from the phase 2 LEAP-004 study
Poster Session
Abstract #9559
June 1, 2024
1:30 PM CDT

Lenvatinib

Differentiated Thyroid Cancer

Real-World Evidence Patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) with BRAF V600E and/or K601E Mutation Status – A real-world view of effectiveness of lenvatinib monotherapy
Poster Session
Abstract #6098
June 2, 2024
9:00 AM CDT

Gastrointestinal Cancer REFLECT ctDNA analysis of patients (pts) with unresectable hepatocellular carcinoma (uHCC) treated with lenvatinib (LEN) or sorafenib (SOR) as 1L therapy
Poster Session
Abstract #4094
June 1, 2024
1:30 PM CDT

Eribulin
Breast Cancer JBCRG-M06/ EMERALD 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, non-inferiority phase 3 trial in Japan (JBCRG-M06/EMERALD)
Oral Abstract Session
Abstract #1007
June 1, 2024
5:00 PM CDT

Pipeline
Breast Cancer BB-1701 An open-label, multicenter, phase 2 study to evaluate the safety and efficacy of BB-1701, a novel antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2), in previously treated patients with HER2-positive (HER2+) or HER2-low unresectable or metastatic breast cancer (BC)
Poster Session
Abstract #TPS1122
June 2, 2024
9:00 AM CDT

tasurgratinib Phase Ib trial of tasurgratinib (E7090) with or without endocrine therapies for patients (pts) with ER+, HER2− recurrent/metastatic breast cancer (BC) after receiving a CDK4/6 inhibitor
Poster Session
Abstract #3103
June 1, 2024
9:00 AM CDT

H3B-6545 H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (-) breast cancer (BC)
Rapid Oral Session
Abstract #1015
June 3, 2024
11:30 AM CDT

H3B-6545 H3B-6545 + palbociclib in patients (pts) with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (-) breast cancer (BC)
Poster Session
Abstract #1051
June 2, 2024
9:00 AM CDT

Solid tumors E7386 Dose-expansion part of a phase 1b global study of E7386 in combination with lenvatinib (LEN) in patients (pts) with hepatocellular carcinoma (HCC) and other solid tumors including endometrial cancer (EC)
Poster Session
Abstract #TPS3169
June 1, 2024
9:00 AM CDT

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 Merck’s anti-PD-1 therapy pembrolizumab. Eisai and Merck are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various 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.