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޲Ʊ Demonstrates Commitment to Oncology Innovation at ASCO 2025

޲Ʊ., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “޲Ʊ”) announced today 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 ޲Ʊ, 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 (; Abstract #4095).

 

Additional research from ޲Ʊ'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 ().

 

"At ޲Ʊ, 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 ޲Ʊ 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."

 

An oral presentation will feature data from the final analysis of the Phase 3 LEAP-015 study evaluating lenvatinib plus pembrolizumab and chemotherapy versus chemotherapy in patients with advanced, metastatic gastroesophageal adenocarcinoma (; Abstract #4001).

 

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 ޲Ʊ 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 TypeStudy/CompoundAbstract TitleAbstract 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

 

In March 2018, ޲Ʊ and MSD, 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 pembrolizumab, MSD’s anti-PD-1 therapy. ޲Ʊ and MSD are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in HCC and esophageal cancer across multiple clinical trials.

 

 

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[Notes to editors]

1. ޲Ʊ’s Focus on Cancer

޲Ʊ positions Oncology as one of its key strategic areas, and aims to contribute to the cure of cancers through the discovery of innovative new drugs with new targets and mechanisms of action under the Deep Human Biology Learning (DHBL) drug discovery and development organization.

By utilizing biomarker data obtained from our products to elucidate the mechanisms of the incidence and root causes of cancer, as well as drug resistance, and using ޲Ʊ Group's precision chemistry technology to turn undruggable intracellular therapeutic targets into druggable ones, we will create new backbone therapeutic drugs.

 

 

*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 ޲Ʊ 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.