ºÚÁÏÍø

• For Print
• January 15, 2019

ºÚÁÏÍø., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “ºÚÁÏÍø”) announced today that presentations on a series of abstracts highlighting the latest data from post-hoc analyses of a Phase III clinical study (REFLECT/Study 304) on its in-house discovered multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (product name: Lenvima^®, “lenvatinib”) as first-line treatment for unresectable hepatocellular carcinoma (HCC) will be presented during the 2019 Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco from January 17 to 19.

Presentations of interest include an oral presentation on a landmark analysis of the relationship between overall survival (OS) and objective response (OR) in patients from REFLECT, and a poster presentation on a post-hoc analysis of responders from REFLECT who received first-line lenvatinib and subsequent anticancer medication.

ºÚÁÏÍø positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

Major Oral and Poster Presentations:

In March 2018, ºÚÁÏÍø entered into a strategic collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), through an affiliate, to jointly develop and commercialize lenvatinib, both as monotherapy and in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy pembrolizumab (product name: KEYTRUDA^®).

Media Inquiries:

Public Relations Department,

ºÚÁÏÍø., Ltd.

+81-(0)3-3817-5120

 [Notes to editors]

1. About LENVIMA (lenvatinib mesylate)

Discovered and developed in house by ºÚÁÏÍø, LENVIMA is an orally administered kinase inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRα; KIT; and RET) involved in tumor angiogenesis, tumor progression and modification of tumor immunity.

Currently, ºÚÁÏÍø has obtained approval for LENVIMA as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, in Europe and Asia. Additionally, ºÚÁÏÍø has obtained approval for the agent in combination with everolimus as a treatment for renal cell carcinoma (second-line) in over 45 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx^® for renal cell carcinoma. In addition, LENVIMA has been approved as a treatment for hepatocellular carcinoma in Japan, the United States, Europe, China and other countries. Furthermore, ºÚÁÏÍø has submitted applications for an indication covering hepatocellular carcinoma in Brazil (March 2018) as well as in other countries.

2. About the REFLECT Study (Study 304)¹

The REFLECT study is a multicenter, open-label, randomized, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for advanced HCC, as a first-line treatment for patients with unresectable HCC. In the study, 954 patients were randomized in a 1:1 ratio to receive lenvatinib 12 mg (≥60 kg) or 8 mg (<60 kg) once a day, depending on baseline body weight (n = 478) or sorafenib 400 mg twice a day (n = 476). Treatment was continued until disease progression or unacceptable toxicity.

The primary endpoint of the study was OS, with the goal of demonstrating non-inferiority.

3. About Hepatocellular Carcinoma (HCC)

Liver cancer is the fourth-leading cause of cancer death, estimated to be responsible for 780,000 deaths per year globally. Additionally, 840,000 cases are newly diagnosed each year.² There is a large regional difference, with about 80% of new cases occurring in Asian regions, including China and Japan. HCC accounts for 85% to 90% of liver cancer. Currently, systemic therapies approved for first line treatment of HCC are limited, underscoring a great unmet medical need.

4. About the ºÚÁÏÍø and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration

In March 2018, ºÚÁÏÍø 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 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 of the LENVIMA and KEYTRUDA combination, 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 (bladder cancer, endometrial cancer, head and neck cancer, hepatocellular carcinoma, melanoma and non-small cell lung cancer). The LEAP clinical program also includes a new basket trial targeting six additional cancer types (biliary duct cancer, breast cancer, colorectal cancer, gastric cancer, glioblastoma and ovarian cancer). The LENVIMA and KEYTRUDA combination is not approved in any cancer types today.

¹ Kudo M et al., “Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial” The Lancet 2018, 391 (10126), 1163-1173.

² GLOBOCAN2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

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