English | 简体中文 | 繁體中文 | 한국어 | 日本語
Monday, 11 December 2023, 10:28 JST
Share:
    

Source: Eisai
Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-001 Trial Evaluating LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma

TOKYO, Dec 11, 2023 - (JCN Newswire) - Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) today announced that the Phase 3 LEAP-001 trial evaluating LENVIMA®, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA®, the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) /MSI-H. 

At the final analysis, KEYTRUDA plus LENVIMA did not improve OS or PFS sufficiently to meet the study’s prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel). The safety profile of LENVIMA plus KEYTRUDA was consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data from this study is ongoing. The companies will work with investigators to share the results with the scientific community. 

“We remain confident in the proven benefit of KEYTRUDA plus LENVIMA for the treatment of appropriate patients with certain types of previously-treated advanced endometrial carcinoma based on results from the KEYNOTE-775/Study 309 trial and will continue to research the KEYTRUDA plus LENVIMA combination in patients with other types of difficult-to-treat cancers,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck & Co., Inc., Rahway, NJ, USA Research Laboratories. “We are disappointed that the LEAP-001 trial did not reach its primary endpoints, as we had hoped to bring another potential treatment option to patients when first diagnosed with certain types of advanced or recurrent endometrial carcinoma.” 

“Results from the LEAP-001 trial underscore the challenges of treating patients with advanced or recurrent endometrial carcinoma in the first-line setting,” said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. “We remain optimistic about clinical development program for LENVIMA plus KEYTRUDA and are proud that the combination has become a standard of care option for patients with certain types of advanced or recurrent endometrial carcinoma whose disease has progressed following prior systemic therapy, and will continue our efforts to contribute to these patients. We are grateful to the patients, their loved ones, and the investigators whose participation is what makes scientific advancement possible.”

LENVIMA plus KEYTRUDA is approved in the U.S., the EU, Japan and other countries for the treatment of certain types of advanced endometrial carcinoma following prior systemic therapy in any setting and advanced renal cell carcinoma (RCC). Lenvatinib is marketed as KISPLYX® for advanced RCC in the EU. Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types, including but not limited to hepatocellular carcinoma, RCC, head and neck cancer, gastric cancer and esophageal cancer, across multiple clinical trials.  

Results from the LEAP-001 trial do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.

For more information, visit https://www.eisai.com/news/2023/news202373.html.

Media Contacts:

Eisai Co., Ltd.

Public Relations:
+81-(0)3-3817-5120

Investor Relations:
+81-(0) 3-3817-5122

Merck & Co., Inc., Rahway, NJ, USA

Media Relations
Julie Cunningham: +1-(617) 519-6264
John Infanti: +1-(609) 500-4714

Investor Relations
Peter Dannenbaum: +1-(732) 594-1579
Damini Chokshi: +1-(732) 594-1577



Topic: Press release summary
Source: Eisai

Sectors: BioTech
https://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

Eisai Related News
2024年10月8日 13時00分 JST
エーザイ、痛風・高尿酸血症治療剤「URECE(R) Tablets」(一般名:ドチヌラド)についてタイで承認を取得
Tuesday, 8 October 2024, 14:00 JST
"Urece Tablets" (Dotinurad) Approved In Thailand For Gout And Hyperuricemia
2024年10月2日 11時00分 JST
エーザイ、サウジアラビアの医薬品販売子会社が事業活動を開始
Wednesday, 2 October 2024, 11:28 JST
Eisai Commences Business Activities At New Pharma Sales Subsidiary In Saudi Arabia
Tuesday, 24 September 2024, 16:06 JST
Rozebalamin(R) for Injection 25 mg (Mecobalamin) Approved in Japan for Amyotrophic Lateral Sclerosis
More news >>
Copyright © 2024 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Cookies Policy | Privacy Policy | Disclaimer | Terms of Use | RSS
US: +1 214 890 4418 | China: +86 181 2376 3721 | Hong Kong: +852 8192 4922 | Singapore: +65 6549 7068 | Tokyo: +81 3 6859 8575