On September 5, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, which is taking place virtually and in-person in Barcelona, Spain from September 13 to 17 (Press release, Eisai, SEP 4, 2024, View Source [SID1234646370]).
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First presentation of results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC) will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium (NCT04246177(New Window); Presentation: #LBA3).
"The late-breaking data from the Phase 3 LEAP-012 trial add to a growing body of research that we have undertaken in hepatocellular carcinoma, reinforcing Eisai’s longstanding commitment to people living with this devastating disease," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "We are eager to share these findings at ESMO (Free ESMO Whitepaper), alongside our other research on lenvatinib monotherapy and in combination with pembrolizumab, and pipeline developments, as this crucial scientific exchange fuels our mission to accelerate progress in oncology and help improve the lives of patients and families affected by cancer."
Additionally, a Mini Oral presentation will feature real-world evidence for patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) treated with lenvatinib monotherapy in Europe and Canada (Presentation: #1926MO). Research into the use of lenvatinib monotherapy in patients with HCC from the Phase 4 STELLAR study (Presentation: #964P) and from a real-world study utilizing the LINK (Liver cancer IN Korea) research network (Presentation: #972P) will be shared in poster presentations. An exploratory analysis from the Phase 3 LEAP-001 trial evaluating tumor response with lenvatinib plus pembrolizumab for patients with advanced or recurrent endometrial carcinoma will also be presented (NCT03884101(New Window); Presentation: #737P).
Research from Eisai’s pipeline includes a quality-of-life analysis from the Phase 3 EMERALD study in Japan evaluating either Eisai’s eribulin (HALAVEN) or a taxane in combination with trastuzumab and pertuzumab in patients with HER2-positive, locally advanced or metastatic breast cancer (NCT03264547(New Window); Presentation: #373P); findings from a Phase 1b dose-expansion cohort evaluating E7386 (a CBP/β-catenin interaction inhibitor) in combination with lenvatinib in patients with advanced endometrial carcinoma with progression following prior anti-PD-(L)1 immunotherapy and platinum-based chemotherapy (NCT04008797(New Window); Presentation: #738P); as well as presentations for BB-1701, an antibody drug conjugate which combines an anti-HER2 antibody with Eisai’s approved anticancer drug eribulin via its linker, in previously-treated patients with HER2-positive or HER2-low unresectable or metastatic breast cancer (NCT06188559(New Window); Presentation: #437TiP) and non-small cell lung cancer patients with HER2 mutation/amplification (Presentation: #1296P; presented by Bliss Biopharmaceutical Co., Ltd), respectively.
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. Regular abstracts will be made available via the ESMO (Free ESMO Whitepaper) website on Monday, September 9, at 12:05 AM Central European Summer Time (CEST). Late-breaking abstracts accepted for presentation at ESMO (Free ESMO Whitepaper) as a Proffered Paper or Mini Oral will be published on the ESMO (Free ESMO Whitepaper) website at 12:05 AM CEST on the day of the presentation. Posters will be on display from 9:00 AM – 5:00 PM CEST on the day of their poster session.
Cancer Type Study/
Compound Abstract Title Abstract Type & Details
Lenvatinib Plus Pembrolizumab
Genitourinary Cancer LEAP-012 Transarterial chemoembolization (TACE) with or without lenvatinib (len) plus pembrolizumab (pembro) for intermediate stage hepatocellular carcinoma (HCC): phase 3 LEAP-012 study
Presidential Symposium
(Proffered Paper Session)
Presentation #LBA3
September 14, 2024
5:36-5:48 PM CEST
Endometrial Carcinoma
LEAP-001
Characterization of tumor response with lenvatinib plus pembrolizumab (LEN + Pembro) in the ENGOT-en9/LEAP-001 study
Poster Session
Presentation #737P
September 14, 2024
Lenvatinib
Differentiated
Thyroid Cancer Real-World Evidence
Radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) patients treated with lenvatinib monotherapy: real-world treatment patterns and clinical outcomes in Europe and Canada
Mini Oral Presentation
Presentation #1926MO
September 13, 2024
4:05-4:10 PM CEST
Gastrointestinal Cancer
Real-World Evidence
Efficacy and safety of lenvatinib vs. sorafenib in hepatocellular carcinoma: a multi-center real-world study from the LINK research network
Poster Session
Presentation #972P
September 16, 2024
STELLAR
Lenvatinib (L) and sorafenib (S) in patients (pts) with advanced or unresectable hepatocellular carcinoma (uHCC): an international, multicenter, phase 4 study (STELLAR)
Poster Session
Presentation #964P
September 16, 2024
Eribulin
Breast Cancer JBCRG-M06/ EMERALD
Quality-of-life outcomes in patients with HER2-positive, locally advanced or metastatic breast cancer treated with eribulin mesylate in combination with trastuzumab and pertuzumab in the phase 3 JBCRG-M06/EMERALD study
Poster Session
Presentation #373P
September 16, 2024
Pipeline
Endometrial Carcinoma E7386 Global, phase 1b dose-expansion cohort of E7386 + lenvatinib (LEN) in patients (pts) with advanced (a) endometrial cancer (EC) that progressed on platinum-based chemotherapy (CTx) and an anti-PD-(L)1 immunotherapy (IO)
Poster Session
Presentation #738P
September 14, 2024
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 HER2, in previously treated patients (pts) with HER2+ or HER2-low unresectable or metastatic (M) breast cancer (BC)
Poster Session
Presentation #437TiP
September 16, 2024
Non-Small Cell Lung Cancer BB-1701 A phase 2 study to evaluate the efficacy and safety of BB-1701 in advanced or metastatic NSCLC patients with HER2 mutation/amplification (Presented by Bliss Biopharmaceutical Co., Ltd.)
Poster Session
Presentation #1296P
September 14, 2024
In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of 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 the anti-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.
In May 2023, Eisai entered into a joint clinical trial collaboration 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 is currently investigating BB-1701 in a Phase 2 clinical trial in Japan and the United States for breast cancer, and BlissBio is investigating a Phase 1/2 clinical trial in the United States and China for HER2-expressing solid tumors.