Eisai and Merck’s Lenvima plus Keytruda Combination Receives FDA Breakthrough Therapy Designation as Potential First-Line Treatment for Unresectable Hepatocellular Carcinoma

TOKYO, Aug. 26, 2019 /PRNewswire/ -- Eisai Co., Ltd. (headquartered in Tokyo, Japan; President and CEO: Haruo Naito; hereinafter referred to as “Eisai”) and Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK, known as MSD outside the United States and Canada) recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the combination therapy of LENVIMA (Chinese brand name: “Lenvima”) and KEYTRUDA (Chinese brand name: “Keytruda”) as a potential first-line treatment for patients with advanced unresectable hepatocellular carcinoma (HCC) who are not candidates for locoregional therapies. Lenvima is an oral protein kinase inhibitor developed by Eisai. Keytruda is an anti-PD-1 therapy developed by Merck. This marks the third Breakthrough Therapy Designation awarded to the Lenvima plus Keytruda combination regimen. The previous two Breakthrough Therapy Designations for this combination were granted in January 2018 for patients with advanced progressive and/or metastatic renal cell carcinoma, and in July 2018 for patients with advanced or metastatic endometrial carcinoma that is not highly microsatellite instability-high (MSI-H)/mismatch repair proficient (pMMR).

Designation as a “Breakthrough Therapy” is an FDA policy aimed at accelerating the development and review of drugs intended to treat serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must demonstrate that the therapy has the potential to provide substantial improvement over currently available therapies on at least one clinically significant endpoint.

The “Breakthrough Therapy” designation was granted based on the latest interim results from the Phase 1b KEYNOTE-524/116 trial. The interim analysis data from this study were presented at the 2019 American Association for Cancer Research (AACR) Annual Meeting.

Lenvima + Keytruda combination therapy is still under investigation, with its efficacy and safety not yet established, and it has not been approved for the treatment of any cancer type.

“We are pleased that the FDA has recognized the importance of designating the combination therapy of Lenvima + Keytruda as a breakthrough therapy for advanced unresectable hepatocellular carcinoma that cannot be treated locally.”。”Takashi Owa, Ph.D., Vice President of Eisai’s Oncology Business Division and Chief Medical Innovation Officer, stated, “We are committed to collaborating with MSD, potentially bringing another important option to patients.”

"As part of our ongoing collaboration with Eisai, we are committed to evaluating the potential of Keytruda + Lenvima in treating various types of cancer."。”Jonathan Cheng, M.D., Vice President of Oncology Clinical Research at MSD Research Laboratories, stated, “Based on this Breakthrough Therapy Designation by the FDA, we look forward to collaborating with Eisai to include this refractory cancer in our indications. This will enable us to help more patients with this combination therapy.”

On the Strategic Partnership between Eisai and MSD

In March 2018, Eisai and Merck & Co., Inc. (known as MSD in the United States and Canada) entered into a strategic global collaboration for the joint development and commercialization of Lenvima through their subsidiaries. Under the agreement, the respective companies will jointly develop, manufacture, and commercialize Lenvima. The drug can be used either as monotherapy or in combination with Keytruda, an anti-PD-1 agent developed by Merck & Co., Inc.

In addition to the ongoing clinical studies evaluating the combination therapy of Lenvima and Keytruda for several tumor types, including renal cell carcinoma, the relevant companies will jointly launch new clinical studies through the LEAP (Lenvatinib and Pembrolizumab) clinical program. This program will assess the potential of this combination therapy to support 11 indications across six cancers: endometrial cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and urothelial carcinoma. The LEAP clinical program also includes a next-generation basket trial targeting six other cancer types: biliary tract cancer, triple-negative breast cancer, colorectal cancer, gastric cancer, glioblastoma, and ovarian cancer. The Lenvima plus Keytruda combination therapy is not yet approved for the treatment of any cancer type.

About Eisai

Eisai is a global, research and development-focused pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. Our corporate mission is to “give first thought to patients and their families and contribute to the enhancement of their health and happiness,” which embodies our human health care (hhc) philosophy. We are committed to realizing our hhc concept by providing innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. Guided by the spirit of hhc, we further fulfill this commitment by leveraging our scientific expertise, clinical capabilities, and patient insights to develop innovative solutions that address society’s most challenging needs, including neglected tropical diseases and the Sustainable Development Goals.

For more information about Eisai, please visitwww.eisai.com(Global Website),us.eisai.com(US website) orwww.eisai.co.uk(UK website), and in ourTwitter（United StatesTwitter,Global) and contact us on LinkedIn (US).

About MSD

Merck & Co., Inc. is a leading global biopharmaceutical company, known as MSD outside the United States and Canada. For more than a century, the company has been inventing for life, bringing medicines and vaccines to many of the world’s most challenging diseases. We engage with customers through prescription medicines, vaccines, biologics therapies, and animal health products, operating in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to advancing healthcare through impactful policies, planning, and partnerships. Today, Merck & Co., Inc. continues to stand at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world, including cancer, cardiometabolic diseases, emerging animal diseases, Alzheimer’s disease, and infectious diseases such as HIV/AIDS and Ebola. For more information, please visitwww.merck.com , and throughTwitter, Facebook, Instagram, YouTube andLinkedInContact Us.

Merck & Co., Inc. Focuses on Cancer Research

Our goal is to translate breakthrough science into innovative oncology medicines to help cancer patients worldwide. At Merck in Kenilworth, New Jersey, USA, “the potential to bring new hope to cancer patients” drives our mission, and “supporting access to cancer medicines” is our commitment. Merck in Kenilworth, New Jersey, USA, is dedicated to exploring the potential of immuno-oncology, which is part of our focused oncology portfolio and represents one of the largest R&D programs in the industry across more than 30 tumor types. We will continue to strengthen our portfolio through strategic acquisitions and prioritize the development of several promising oncology candidates with the potential to advance the treatment of advanced-stage cancers. For more information about our oncology clinical trials, please visitwww.merck.com/clinicaltrials。

MSD Forward-Looking Statements

A press release from Merck & Co., Inc., Kenilworth, New Jersey, U.S.A. (hereinafter referred to as the “Company”) includes certain “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 on current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. With respect to pipeline products, there can be no assurance that such products will receive the necessary regulatory approvals or demonstrate commercial success. If underlying assumptions prove inaccurate or if risks or uncertainties materialize, actual results may differ materially from those stated in the forward-looking statements.

Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including fluctuations in interest rates and currency exchange rates; the impact of U.S. and international pharmaceutical industry regulations and healthcare legislation; global trends toward controlling healthcare costs; technological advancements, new products, and patents obtained by competitors; inherent challenges in the new product development process, including obtaining regulatory approval; the Company’s ability to accurately forecast future market conditions; production difficulties or delays; financial instability and sovereign risk in the international economy; dependence on the benefits of patent and other protections for the Company’s innovative products; and litigation risks, including patent litigation and/or regulatory actions.

The Company is under no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. For other factors that may cause results to differ materially from those stated in the forward-looking statements, please refer to the Company’s Annual Report on Form 10-K for 2018 and other filings submitted by the Company to the U.S. Securities and Exchange Commission (SEC), which are available on the SEC website (www.sec.gov) consult.