ASCO 2025: Eisai highlights Lenvatinib research in HCC and endometrial cancer

Eisai Co., Ltd. announced the presentation of clinical research across its oncology portfolio and pipeline during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO25), which is taking place in Chicago, Illinois, and virtually, from May 30 to June 3. Notable data include findings from the Phase 3 LEAP-002 study, which evaluated lenvatinib (LENVIMA®), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus pembrolizumab (KEYTRUDA®), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, versus lenvatinib monotherapy for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The poster presentation will feature long-term follow-up data providing further insights into lenvatinib’s role in the treatment landscape for patients affected by HCC (NCT03713593; Abstract #4095). Additional research from Eisai’s pipeline will focus on E7386, a CBP/β-catenin interaction inhibitor, in combination with lenvatinib. This includes a dose optimization trial-in-progress presentation (Abstract #TPS5632) and dose expansion findings (Abstract #5599) in patients with advanced or recurrent endometrial carcinoma (NCT04008797). “At Eisai, our pursuit of scientific advancement is fueled by a deep commitment to our human health care concept. 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, while our pipeline work in advanced endometrial carcinoma represents our continued dedication to addressing areas with unmet medical needs through innovative therapeutic approaches.”

The full list of Eisai presentations is included below.

These abstracts will be made available via the ASCO website on Thursday, May 22, 2025, at 4:00 PM Central Daylight Time (CDT). Cancer Type Study/Compound Abstract Title Abstract Type & Details Lenvatinib Plus Pembrolizumab Gastrointestinal Cancer LEAP-002 LEAP-002 long-term follow-up: Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma Poster Session Abstract #4095 May 31, 2025 9:00 AM CDT LEAP-015 Lenvatinib plus pembrolizumab and chemotherapy versus chemotherapy in advanced, metastatic gastroesophageal adenocarcinoma: The Phase 3, randomized LEAP-015 study Oral Abstract Session Abstract #4001 May 31, 2025 3:12 PM CDT Melanoma LEAP-003 First-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab in Chinese patients with unresectable or metastatic melanoma: results from LEAP-003 Poster Session Abstract #9553 May 31, 2025 9:00 AM CDT Pipeline Gynecologic Cancer E7386 Randomized study evaluating optimal dose, efficacy and safety of E7386 + lenvatinib versus treatment of physicians’ choice in advanced/recurrent endometrial carcinoma previously treated with anti-PD-(L)1 immunotherapy Poster Session Abstract #TPS5632 June 1, 2025 9:00 AM CDT E7386 Study 102: Global dose-expansion cohort of E7386 + lenvatinib (LEN) in patients (pts) with advanced endometrial cancer (aEC) that progressed on platinum-based chemotherapy (chemo) and an anti-PD-(L)1 immunotherapy (IO) Poster Session Abstract #5599 June 1, 2025 9:00 AM CDT Pan-Tumor Systematic Review The PRO-CTCAE in oncology clinical trials: Insights from a targeted literature review For Online Publication