1. Home
  2. Press release
Jul 09, 2020 12:11 JST

Source: Eisai

Eisai and Merck Receive Complete Response Letter for LENVIMA (lenvatinib) plus KEYTRUDA (pembrolizumab) Combination as First-Line Treatment for Unresectable Hepatocellular Carcinoma

TOKYO, Jul 09, 2020 - (JCN Newswire) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Eisai's and Merck's applications seeking accelerated approval of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, Merck's anti-PD-1 therapy, for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

The applications were based on data from the Phase 1b Study 116/KEYNOTE-524 trial, which showed clinically meaningful efficacy in the single-arm setting. These data were recently presented at the 2020 American Society of Clinical Oncology Annual Meeting and supported a Breakthrough Therapy designation granted by the FDA in July 2019. Ahead of the PDUFA action dates of Eisai's and Merck's applications, another combination therapy was approved based on a randomized controlled trial that demonstrated overall survival. Consequently, the CRL stated that the applications do not provide evidence that KEYTRUDA in combination with LENVIMA represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for Study 116/KEYNOTE-524 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination. As such, LEAP-002, the Phase 3 trial evaluating the LENVIMA plus KEYTRUDA combination as a first-line treatment for advanced HCC, is currently underway and fully enrolled. The CRL does not impact the currently approved indications for LENVIMA or for KEYTRUDA.

Eisai and Merck are continuing to evaluate the LENVIMA plus KEYTRUDA combination across 13 different tumor types in 18 clinical trials including the LEAP (LEnvatinib And Pembrolizumab) clinical program.

For more information, visit https://www.eisai.com/news/2020/news202039.html.

Contact:
Eisai Co., Ltd.
Public Relations:
+81-(0)3-3817-5120
  
Merck & Co., Inc., Kenilworth, N.J., U.S.A. 
Media Relations
Pamela Eisele: (267) 305-3558
Michael Close: (267) 305-1211
Source: Eisai
Sectors: BioTech, Healthcare & Pharm

Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release

Eisai to Launch "Pariet S," the First Proton Pump Inhibitor RX-to-OTC in Japan
June 02 2025 16:46 JST
 
New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China
May 28 2025 16:45 JST
 
Eisai Demonstrates Commitment to Oncology Innovation at ASCO 2025
May 21 2025 14:00 JST
 
Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro
May 16 2025 16:21 JST
 
Eisai Representative Corporate Officer and CEO Haruo Naito Awarded the Order of the Rising Sun, Gold and Silver Star
April 30 2025 13:17 JST
 
Leqembi (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union
April 18 2025 15:52 JST
 
Eisai to Divest Rights for Pariet in China to Peak Pharma
April 01 2025 12:15 JST
 
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards
March 25 2025 16:28 JST
 
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace
March 25 2025 11:21 JST
 
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time
March 10 2025 19:24 JST
 
More Press release >>

Latest Press Release


Approval in Principle (AiP) for World's First LCO2 / Methanol Carrier
Jun 30, 2025 20:30 JST

Acropolis Rally Greece: Day 4 Sunday success and second overall for TOYOTA GAZOO Racing's Ogier
Jun 30, 2025 20:15 JST

Mitsubishi Fuso-Hino Merger: 4 Firms Collaborate for the Future of Commercial Vehicles
Jun 30, 2025 20:10 JST

Six Companies Establish BlueRebirth Council to Expand Use of Recycled Materials in New Vehicles
Jun 30, 2025 19:25 JST

Honda Changes Plan to Build New Production Plant for Next-generation Fuel Cell Module in Japan
Jun 30, 2025 19:20 JST

MHI-AC&R Receives Recommendation Award of JARAC's 42nd Excellent Energy Saving Equipment Awards
Jun 30, 2025 19:00 JST

The University of Osaka and Fujitsu Japan launch joint research on AI-powered education support for culturally and linguistically diverse children in Japan
Jun 30, 2025 12:00 JST

JCB has launched contactless subway payment services in Shanghai and Beijing, marking the first such service in mainland China
Jun 30, 2025 12:00 JST

Honda Opens "Honda Software Studio Osaka" as New Software Development Operation
Jun 26, 2025 13:30 JST

Honda Issues "Honda ESG Report 2025"
Jun 26, 2025 13:29 JST

Fujitsu's Uvance Wayfinders consulting empowers customers to evolve business foundations leveraging data and AI
Jun 26, 2025 11:00 JST

MHI Receives Contract for Refurbishment of APM System at Singapore Changi Airport
Jun 25, 2025 14:00 JST

Special Summer Event "Tanabata Festival at Anime Tokyo Station" Feature a Public Recording of a Chat and Dramatic Reading by Voice Actors Miina Tominaga and Wataru Takagi on July 7
Jun 25, 2025 11:00 JST

Technica Zen and BSI Professional Services Japan Launch Customizable Training to Strengthen AI Governance in Japanese Companies
Jun 25, 2025 10:00 JST

Executive Appointments in Connection with the Establishment of NESIC Holdings
Jun 23, 2025 19:22 JST

Hua Medicine Announces at 2025 ADA Scientific Sessions that Dorzagliatin Combined with DPP-4 Inhibitor Shows Promise in Reducing Blood Lipids While Restoring Glucose Homeostasis
Jun 23, 2025 13:05 JST

CanSinoBIO Launches Pneumococcal Vaccine: An Innovative Choice to Safeguard Children's Health
Jun 20, 2025 19:06 JST

Sharp Launches A2 Size ePoster Color Electronic Paper Display
Jun 19, 2025 12:08 JST

Fujitsu unveils AI-powered presentation technology, enabling automated multilingual and customizable presentations
Jun 19, 2025 10:25 JST

ULVAC Continues Participation in "Lab-in-Fab" Project to Advance Piezoelectric MEMS Technology, Now Entering a New Phase
Jun 19, 2025 09:30 JST
 More Latest Release >>