Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Breakthrough Therapy Designation from FDA

TOKYO, Jul 23, 2019 – (JCN Newswire) – Eisai, and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for LENVIMA, the orally available kinase inhibitor discovered by Eisai, in combination with KEYTRUDA, Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy, for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) not amenable to locoregional treatment.

This is the third Breakthrough Therapy designation for the LENVIMA plus KEYTRUDA combination. The first two Breakthrough Therapy designations for the combination were in advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic non-microsatellite instability-high (MSI- H)/proficient mismatch repair (pMMR) endometrial carcinoma, received in January 2018 and July 2018, respectively.

The Breakthrough Therapy designation is an FDA program intended to expedite development and review of medicines for serious or life-threatening conditions. In order to qualify for this designation, preliminary clinical evidence must demonstrate that the therapy may provide substantial improvement over currently available therapy on at least one clinically significant endpoint.

This Breakthrough Therapy designation is based on interim results from the Phase 1b trial KEYNOTE-524/Study 116. An earlier interim analysis was presented at the 2019 American Association for Cancer Research (AACR) Annual Meeting.

The combination of LENVIMA plus KEYTRUDA is investigational. The efficacy and safety of this combination has not been established. The LENVIMA plus KEYTRUDA combination is not approved in any cancer types today.

“We are excited that the FDA has recognized the importance of the activity seen with LENVIMA plus KEYTRUDA in combination in advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment with this Breakthrough Therapy designation,” said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. “We are dedicated to working together with Merck & Co., Inc., Kenilworth, N.J., U.S.A. to potentially bring another important option to patients.”

“As part of our ongoing collaboration with Eisai, we are committed to evaluating the potential of KEYTRUDA plus LENVIMA across a number of different types of cancer,” said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. “With this Breakthrough Therapy designation from the FDA, we look forward to working with Eisai to potentially build upon our existing indications for this difficult- to-treat cancer, so that we can help even more patients through a combination approach.”

About Merck& Co., Inc., Kenilworth, N.J., U.S.A.

For more than a century, Merck& Co., Inc., Kenilworth, N.J., U.S.A., a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world?s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck & Co., Inc., Kenilworth, N.J., U.S.A. continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer?s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define 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 in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com

Contact:
Merck & Co., Inc. Kenilworth, N.J., U.S.A. Media Relations Pamela Eisele: (267) 305-3558 Kristen Drake: (908) 334-4688 Public Relations Department, Eisai Co., Ltd. +81-3-3817-5120

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