Eisai to Present Long-Term LEAP-002 Data and Novel Pipeline Advances at ASCO 2025
核心洞察
Eisai will showcase long-term follow-up data from the Phase 3 LEAP-002 study evaluating lenvatinib plus pembrolizumab versus lenvatinib monotherapy in first-line unresectable hepatocellular carcinoma (搜索) treatment.
The company will present research on E7386, a CBP/β-catenin (搜索) interaction inhibitor, in combination with lenvatinib for patients with advanced or recurrent endometrial carcinoma (搜索), addressing significant unmet medical needs.
Final analysis data from the Phase 3 LEAP-015 study examining lenvatinib plus pembrolizumab and chemotherapy in advanced gastroesophageal adenocarcinoma (搜索) will be featured in an oral presentation.
Eisai announced today that it will present significant clinical research across its oncology portfolio and pipeline during the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from May 30 to June 3.
The pharmaceutical company will highlight several important studies, with particular focus on treatments for challenging cancer types with high unmet medical needs. The presentations reflect Eisai's ongoing commitment to advancing cancer care through innovative therapeutic approaches.
Key LEAP-002 Long-Term Data in Hepatocellular Carcinoma
Among the most anticipated presentations is the long-term follow-up data from the Phase 3 LEAP-002 study, which evaluated the combination of lenvatinib (LENVIMA®) plus pembrolizumab (KEYTRUDA®) versus lenvatinib monotherapy for first-line treatment of unresectable hepatocellular carcinoma (搜索) (HCC).
The poster presentation (Abstract #4095) will provide valuable insights into lenvatinib's established role in the treatment landscape for patients with HCC, a notoriously difficult-to-treat form of liver cancer with poor prognosis. This data builds upon Eisai's extensive research in liver cancer therapeutics.
Hepatocellular carcinoma (搜索) represents a significant global health burden, with limited effective treatment options for patients with advanced disease. The LEAP-002 long-term data is expected to further clarify the clinical utility of lenvatinib-based regimens in this patient population.
Novel Pipeline Advances in Endometrial Carcinoma
Eisai will also present research on its investigational compound E7386, a CBP/β-catenin (搜索) interaction inhibitor, in combination with lenvatinib for patients with advanced or recurrent endometrial carcinoma (搜索).
Two presentations will focus on this novel approach:
- A dose optimization trial-in-progress presentation (Abstract #TPS5632)
- Dose expansion findings (Abstract #5599) from the ongoing clinical trial (NCT04008797)
E7386 represents an innovative therapeutic strategy, as it targets the Wnt/β-catenin (搜索) signaling pathway by blocking the interaction between CBP (CREB binding protein) and β-catenin. This mechanism is designed to inhibit not only ligand-dependent activation but also activation caused by gene mutations in Wnt signaling factors such as adenomatous polyposis coli (APC) and β-catenin.
The compound was developed through collaboration between Eisai and PRISM BioLab Co., Ltd. (搜索), highlighting Eisai's commitment to partnership-driven innovation in oncology.
LEAP-015 Final Analysis in Gastroesophageal Adenocarcinoma
An oral presentation will feature data from the final analysis of the Phase 3 LEAP-015 study (Abstract #4001), which evaluated lenvatinib plus pembrolizumab and chemotherapy versus chemotherapy alone in patients with advanced, metastatic gastroesophageal adenocarcinoma (搜索).
This presentation will provide important insights into potential new treatment approaches for patients with this aggressive gastrointestinal malignancy, which continues to have poor outcomes despite recent therapeutic advances.
Eisai's Human Health Care Philosophy
"At Eisai, our pursuit of scientific advancement is fueled by a deep commitment to our human health care philosophy. We believe patients deserve our best efforts, and we endeavor to deliver that by pushing boundaries in oncology research, particularly in challenging areas," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc.
"Our data at ASCO 2025 showcase this principle in action. The long-term follow-up data from LEAP-002 contribute to our ongoing body of research and further reinforce our understanding of LENVIMA's established role in unresectable hepatocellular carcinoma (搜索), while our pipeline work in advanced endometrial carcinoma (搜索) represents our continued dedication to addressing areas with unmet medical needs through innovative therapeutic approaches."
Strategic Collaboration with Merck
The presentations at ASCO 2025 build upon Eisai's strategic collaboration with Merck (搜索) (known as MSD outside the United States and Canada), which began in March 2018. This partnership focuses on the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with Merck's anti-PD-1 therapy, pembrolizumab.
The companies are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across multiple tumor types, with particular emphasis on HCC and esophageal cancer.
The abstracts from Eisai's presentations will be available via the ASCO website on Thursday, May 22, 2025, at 5:00 PM EDT, providing the oncology community with early access to these important research findings.
About Lenvatinib (LENVIMA®)
Lenvatinib is a multiple receptor tyrosine kinase inhibitor discovered and developed by Eisai. It works by inhibiting the kinase activities of vascular endothelial growth factor (VEGF (搜索)) receptors VEGFR1, VEGFR2, and VEGFR3, as well as other kinases involved in pathogenic angiogenesis, tumor growth, and cancer progression.
The drug is currently approved for multiple indications, including:
- Treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer
- First-line treatment of unresectable hepatocellular carcinoma
- Treatment of advanced renal cell carcinoma, both in combination with pembrolizumab as first-line therapy and in combination with everolimus following prior anti-angiogenic therapy
- Treatment of advanced endometrial carcinoma in combination with pembrolizumab for specific patient populations
The ongoing research presented at ASCO 2025 aims to further expand the clinical utility of lenvatinib across multiple difficult-to-treat cancer types, potentially offering new hope to patients with limited therapeutic options.