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- May 23, 2024
Eisai Co., Ltd. (Headquarters: Tokyo; Representative Executive Officer and CEO: Naito Haruo) is holding the various types of cancer products and products developed in our cancer field at the “American Society of Clinical Oncology (American Society of Clinical Oncology: ASCO) Annual Meeting” (2024 ASCO Annual Meeting) to be held in virtual format in Chicago, Illinois, USA from 2024/5/31 to 6/4 I would like to inform you that we will announce the latest findings in
At our society, the oral tyrosine kinase inhibitor lenvatinib (product name: Renbima) developed by our company) and Merck & Co., Inc., Rahway, NJ, USA's anti-PD-1 antibody pembrolizumab (product name: KeytrudaClinical phase III CLEAR (307) trial that evaluated the combination therapy of) compared to sunitinib as a primary treatment for advanced renal cell cancer/KEYNOTE-581 exam (NCT02811861Biomarker analysis results for) will be presented orally (abstract number: 4504). In addition, findings on disease progression and post-treatment patterns in this trial will be presented on a poster (abstract number: 4524).
Dr. Takashi Yamato, our Managing Executive Officer and Chief Scientific Officer, said, “We are promoting a new approach to accelerate progress in oncology based on the latest science in order to strengthen our commitment to the needs of patients diagnosed with cancer and their families based on the human health care philosophy. We look forward to sharing our latest findings on our pipeline, including lenvatinib and pembrolizumab combinations, which are standard treatment options for primary therapy for advanced renal cell cancer, and various modalities for advanced cancer, to achieve our goal of improving patient survival.”
Other important research results related to our pipeline include oral presentation of clinical phase III JBCRG-M06/EMERALD test results in Japan that evaluates the combination of trastuzumab and pertuzumab with eribrine mesylate or taxane created by our company for HER2 positive locally advanced or metastatic breast cancer (NCT03264547, abstract number: 1007). Furthermore, an overview of the clinical phase II trial of BB-1701, an antibody-drug complex targeting HER2, targeting HER2 positive, unresectable or metastatic breast cancer with low HER2 expression (NCT06188559, abstract number: TPS1122), clinical Ib trial results of tasulgratinib (development code: E7090) with or without endocrine therapy targeting ER positive and HER2 negative recurrent/metastatic breast cancer with a history of treatment with CDK4/6 inhibitors (NCT04572295, abstract number: 3103), Overview of an international joint clinical phase Ib trial of combination therapy with E7386 and lenvatinib targeting solid cancers including hepatocellular carcinoma and endometrial cancer (NCT04008797, abstract number: TPS3169) will be presented on the poster.
Presentations at this conference are as follows. Abstracts (abstracts) are scheduled to be released on 2024/5/23 at 4:00 PM (US Central Daylight Time).
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| Types of cancer | Tests/Compounds | Abstract title | Presentation format and details (US Central Daylight Time) |
|---|---|---|---|
| Combination therapy with lenvatinib and pembrolizumab | |||
| Genitourinary Cancers | CLEAR test | Biomarker analysis in patients with advanced renal cell cancer in clinical phase III CLEAR trials | Oral abstract session |
| Genitourinary Cancers | CLEAR test | Comparison of lenvatinib plus pembrolizumab and sunitinib in advanced renal cell carcinoma: disease progression and posttreatment patterns in CLEAR trials | Poster session |
| melanoma | LEAP-004 exam | Combination treatment of lenvatinib and pembrolizumab in patients with advanced melanoma advanced with anti-PD- (L) 1 therapy: 4 years or more follow-up since clinical phase II LEAP-004 trial | Poster session |
| lenvatinib | |||
| Differentiated type thyroid cancer | Real world evidence | BRAF V600E and/or patients with radioactive iodine treatment-resistant differentiated thyroid cancer with K601E mutations - a real-world perspective on the efficacy of lenvatinib monotherapy | Poster session |
| Gastrointestinal cancer | REFLECT test | ctDNA analysis of patients with unresectable hepatocellular carcinoma who received lenvatinib or sorafenib as primary treatment | Poster session |
| elibrine | |||
| breast cancer | JBCRG-M06/EMERALD trials | Combination therapy with trastuzumab and pertuzumab plus eribrine mesylate or taxane as first-line chemotherapy for HER2-positive, locally advanced, or metastatic breast cancer: clinical phase III trial results with multicenter, randomized, and noninferiority verification in Japan (JBCRG-M06/EMERALD) | Oral abstract session |
| pipelines | |||
| breast cancer | BB-1701 | An open-label multicenter clinical phase II trial evaluating the safety and efficacy of BB-1701, a novel antibody-drug complex (ADC) targeting human epidermal growth factor receptor 2 (HER2), for patients with HER2-positive or HER2-low expression unresectable or metastatic breast cancer with a history of treatment | Poster session |
| tasulgratinib | ER positive, HER2 negative, recurrent after administration of CDK4/6 inhibitors/Clinical phase Ib trial of tasulgratinib (E7090) with or without endocrine therapy for patients with metastatic breast cancer | Poster session | |
| H3B-6545 | H3B-6545 in female patients with locally advanced/metastatic estrogen receptor-positive and HER2 negative breast cancer | Poster session | |
| H3B-6545 | Local progression/Combination therapy with H3B-6545 and palbociclib in patients with metastatic estrogen receptor-positive and HER2-negative breast cancer | Poster session | |
| solid cancer | E7386 | Dose-escalation part of an international joint clinical phase Ib trial of E7386 and lenvatinib combination therapy for patients with solid cancer, including hepatocellular carcinoma and endometrial cancer | Poster session |
Regarding lenvatinib monotherapy and combination therapy with pembrolizumab, we signed a strategic partnership agreement with Merck & Co., Inc., Rahway, NJ, USA in 2018/3 for global co-development and joint marketing. Both companies are LEAP (LENvatinib And P(embrolizumab) We are conducting multiple clinical trials of this combination therapy in various cancer types through the clinical program.
Regarding BB-1701, which is an antibody drug complex targeting HER2, we signed a joint development agreement with Bliss Biopharmaceuticals (Hangzhou) Co., Ltd. (headquarters: Zhejiang Province, China; hereafter, BlissBio) in 2023/5 with option rights for a strategic partnership. We and BlissBio are conducting clinical phase II trials targeting breast cancer in Japan and the United States, and clinical phase I/II trials targeting solid cancers with HER2 expression in the US and China.
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＜Reference materials＞
- 1. About our efforts in the field of cancer
We have the “cancer area” as one of the strategically important areas, and under the Deep Human Biology Learning drug discovery system, we focus on research and development of anticancer drugs in drug discovery areas (domains) such as “microenvironment,” “protein homeostasis failure,” “cell lineage and cell differentiation,” and “inflammation associated with cell aging, hypoxia, and oxidative stress,” based on human biology. We aim to contribute to the realization of cancer cure by creating innovative drugs with new targets and mechanisms of action from these domains.
*1 key trudersis a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
*2 E7386 is a product co-created with PRISM BioLab Co., Ltd. (headquarters: Kanagawa Prefecture).
*3 Announcements with TPS (Trial in Progress Submission) added to the abstract number indicate that the test is in the middle stage, and do not announce the final test results.