Eisai to Present Data on Oncology Pipeline and Products at 54th ASCO Annual Meeting

Latest Data on Lenvima (Lenvatinib) / Keytuda (Pembrolizumab) Combination Therapy to be Presented

TOKYO, May 17, 2018 - (JCN Newswire) - Eisai Co., Ltd. announced today that presentations on a series of abstracts highlighting updates regarding its in-house discovered multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (product name: Lenvima, "lenvatinib") will be presented during the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, the United States, from June 1 to 5, 2018.

Major poster presentations at this year's meeting include highlights of the latest data from the renal cell carcinoma, endometrial carcinoma and squamous cell carcinoma of the head and neck cohorts of the Phase Ib/II clinical study (Study 111) of lenvatinib in combination with the Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), anti-PD-1 therapy pembrolizumab (product name: KEYTRUDA) in select solid tumors, as well as the latest data from a Phase Ib clinical study (Study 116) of lenvatinib in combination with pembrolizumab in hepatocellular carcinoma.

In March 2018, Eisai entered into a global strategic oncology collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A. to jointly develop and commercialize lenvatinib, as monotherapy and in combination with pembrolizumab.

Eisai 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.

About LENVIMA (lenvatinib mesylate)

Discovered by Eisai, LENVIMA is an orally administered multiple receptor tyrosine kinase (RTK) 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 PDGFRalpha; KIT; and RET) involved in tumor angiogenesis, tumor progression and modification of tumor immunity.

Currently, LENVIMA is approved as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, in Europe and Asia. Additionally, Eisai has obtained approval for the agent in combination with everolimus as a treatment for renal cell carcinoma (second-line) in over 40 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. Furthermore, Lenvima has been approved in Japan for unresectable hepatocellular carcinoma (HCC). Outside of Japan, Eisai has submitted applications for an indication covering hepatocellular carcinoma in the United States and Europe (July 2017), China (October 2017), Taiwan (December 2017) and other countries.

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., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will develop and commercialize LENVIMA jointly, both as monotherapy and in combination with Merck & Co., Inc. Kenilworth N.J., U.S.A.'s anti-PD-1 therapy KEYTRUDA (pembrolizumab). In addition to ongoing clinical studies of the combination, the companies will jointly initiate new clinical studies evaluating the LENVIMA/KEYTRUDA combination to support 11 potential indications in six types of cancer (endometrial cancer, non-small cell lung cancer, hepatocellular carcinoma, head and neck cancer, bladder cancer and melanoma), as well as a basket trial targeting six additional cancer types. The LENVIMA/KEYTRUDA combination is not approved in any cancer types today.

About Eisai

Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.

Contact:
Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120

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