TOKYO, Jul 9, 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.

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About Eisai

Eisai Co., Ltd. defines our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through working with key stakeholders to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit
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

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