Eisai, BioTech

TOKYO, Feb 12, 2018 - (JCN Newswire) - Eisai Co., Ltd.

12.02.2018 - 03:48:18

Eisai's Phase III Trial Results of Anticancer Agent Lenvatinib in Hepatocellular Carcinoma Published in The Lancet. announced that the results of a Phase III study (REFLECT study, Study 304) of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: Lenvima/Kisplyx, "lenvatinib") in patients with hepatocellular carcinoma (HCC) have been published in the online version of The Lancet,(1) which is one of the world's most prestigious medical journals and was recently ranked second in the world in terms of Impact Factor. (Lead author: Professor and Chairman Masatoshi Kudo of Kindai University Faculty of Medicine, Title of paper: "Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial").

The REFLECT study reported on in the paper was a multicenter, open-label, randomized, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for advanced hepatocellular carcinoma, as a first-line treatment in patients with unresectable HCC. In this study, lenvatinib demonstrated a treatment effect on the primary endpoint of Overall Survival (OS) by statistical confirmation of non-inferiority to sorafenib. Additionally, lenvatinib showed highly statistically significant and clinically meaningful improvements in the secondary endpoints of Progression Free Survival (PFS), Time To Progression (TTP), and Objective Response Rate (ORR).In this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known safety profile of lenvatinib.

About RECIST (Response Evaluation Criteria In Solid Tumors)

RECIST1.1 is a set of assessment criteria used to evaluate effects on solid cancers (based on changes in tumor diameter). mRECIST is a new criteria that takes into account areas of tumor necrosis in addition to RECIST1.1.

About Hepatocellular Carcinoma (HCC)

Liver cancer is the second-leading cause of cancer death, estimated to be responsible for 750,000 deaths per year globally. Additionally, 780,000 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 firstline treatment of HCC are limited, underscoring a great unmet medical need.

About The Lancet

First published in 1823 and with a history spanning over 190 years, The Lancet is an influential medical journal that is highly regarded worldwide.

Impact Factor is based on "2016 Journal Citation Reports, Clarivate Analytics 2017."

(1) M Kudo, 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

(2) GLOBOCAN2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. http://globocan.iarc.fr/

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.

Source: Eisai

Public Relations Department,
Eisai Co., Ltd.

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