Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Breakthrough Therapy Designation from FDA for LENVIMA® (lenvatinib) plus KEYTRUDA® (pembrolizumab) Combination Treatment
as Potential First-Line Treatment of Patients with Advanced Unresectable Hepatocellular Carcinoma Not Amenable to Locoregional Treatment
Tokyo and Kenilworth, N.J.,[July 23, 2019] – Eisai (Headquarters: Tokyo, CEO: Haruo Naito), 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。”
Eisai Co。, Ltd。 Merck & Co., Inc. Kenilworth, N.J., U.S.A.
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About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration
In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy KEYTRUDA.
In addition to ongoing clinical studies evaluating the LENVIMA and KEYTRUDA combination across several different tumor types, including renal cell carcinoma, the companies will jointly initiate new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program, which will evaluate the combination to support 11 potential indications in six types of cancer (endometrial cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and urothelial cancer). The LEAP clinical program also includes a new basket trial targeting six additional cancer types (biliary tract cancer, triple negative breast cancer, colorectal cancer, gastric cancer, glioblastoma and ovarian cancer). The LENVIMA and KEYTRUDA combination is not approved in any cancer types today.
Eisai is a leading global research and development-based pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. 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. We strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including Oncology and Neurology. In the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the Sustainable Development Goals.
For more information about Eisai, please visit (for global), (for U.S.) or (for U.K.), and connect with us on Twitter (。 and ) and (for U.S.).
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 and connect with us on , , , and .
Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck & Co., Inc., Kenilworth, N.J., U.S.A., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck & Co., Inc., Kenilworth, N.J., U.S.A. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit .
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co。, Inc。, Kenilworth, N。J。, USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U。S。 Private Securities Litigation Reform Act of 1995。 These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties。 There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful。 If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements。
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