Phase III Trial Shows Lenvatinib Meets Primary Endpoint of Progr

Phase III Trial Shows Lenvatinib Meets Primary Endpoint of Progression Free
Survival Benefit in Treatment of Radioiodine-Refractory Differentiated Thyroid
Cancer 
Tokyo, Feb 3, 2014 - (JCN Newswire) -  Eisai Co., Ltd. announced today that the
Phase III SELECT trial (Study 303) of lenvatinib, an investigational selective
tyrosine kinase inhibitor (TKI) with a novel binding mode, the first-in-class
of its kind, met its primary endpoint. Compared to placebo, lenvatinib showed a
highly statistically significant improvement in progression free survival (PFS)
in patients with radioiodine-refractory differentiated thyroid cancer
(RR-DTC). 
The SELECT (Study of (E7080) LEnvatinib in differentiated Cancer of the
Thyroid) study was a multicenter, randomized, double-blind, placebo-controlled
Phase III study to compare the PFS of patients with RR-DTC and radiographic
evidence of disease progression within the prior 12 months, treated with
once-daily, oral lenvatinib (24 mg) versus placebo. Secondary endpoints of the
study included overall response rate (ORR), overall survival (OS) and safety.
The study enrolled 392 patients at over 100 sites in Europe, North and South
America and Asia and was conducted by Eisai in collaboration with the SFJ
Pharmaceuticals Group. The preliminary safety analysis showed that the five
most common adverse reactions were hypertension, diarrhea, decreased appetite,
decreased weight and nausea. 
Based on these clinical results, Eisai will submit marketing authorization
applications for lenvatinib to health authorities in Japan, the United States
and Europe. If approved, lenvatinib will be the first molecular-targeted small
molecule agent developed by a Japanese pharmaceutical company. 
Thyroid cancer is the most common endocrine malignancy and global figures show
that its incidence has significantly increased over the last 50 years. RR-DTC,
a life-threatening form of the disease, has a significant unmet treatment need.
Lenvatinib, discovered and developed by Eisai, was granted Orphan Drug
Designation (ODD) in Japan, the United States and Europe. 
Eisai has also initiated a global Phase III trial of lenvatinib in
hepatocellular carcinoma (HCC) and is conducting Phase II studies of lenvatinib
in several other tumor types. Eisai is committed to understanding the potential
clinical benefits of lenvatinib in order to further contribute to patients with
cancer, including patients with thyroid cancer, and their families. 
About Lenvatinib (E7080) 
Lenvatinib, discovered and developed by Eisai, is an orally active, selective
inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode,
including KDR (VEGFR-2), Flt-1 (VEGFR-1), RET, FGFR1, PDGFR-Beta and c-kit,
involved in angiogenesis and tumor proliferation. It is currently under
development as a potential treatment for thyroid, hepatocellular (Phase III),
endometrial (Phase II) and other solid tumor types. Lenvatinib was granted
Orphan Drug Designation (ODD) in Japan for thyroid cancer in August 2012, in
the United States for follicular, medullary, anaplastic, and metastatic or
locally advanced papillary thyroid cancer in December 2012, and in Europe for
follicular and papillary thyroid cancer in April 2013. 
About Thyroid Cancer 
Thyroid cancer refers to cancer that forms in the tissues of the thyroid
gland, located at the base of the throat near the trachea. It is more common in
women than in men and usually occurs between the ages of 25 and 65. The most
common types of thyroid cancer, papillary and follicular (including Hurthle
cell), are classified as differentiated thyroid cancer and account for
approximately 95% of all cases. The remaining cases are classified as either
undifferentiated (3-5% of cases) and medullary carcinoma (1-2% of cases). While
most differentiated thyroid cancer patients are curable with surgery and
radioactive iodine treatment, a small percentage of patients do not respond to
therapy. There are limited treatment options for this difficult-to-treat,
life-threatening and treatment-refractory form of thyroid cancer. 
About the SFJ Pharmaceuticals Group 
The SFJ Pharmaceuticals Group, which includes SFJ Pharma Ltd., is a Global
Drug Development Company, which provides a unique co-development partnering
model for some of the world's top Pharmaceutical and Biotechnology
companies. SFJ uses its financial strength and core team of pharmaceutical
development experts to provide highly customized partnering models in which SFJ
provides the funding and clinical development supervision, necessary to obtain
regulatory approval for some of the most promising drug development programs of
Pharmaceutical and Biotechnology companies. 
Eisai's Commitment to Oncology 
Eisai's commitment to meaningful progress in oncology research, built on
scientific expertise, is supported by a global capability to conduct discovery
and preclinical research, as well as develop small molecules, biologics,
chemotherapies and supportive care agents for cancer across multiple
indications. 
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.
+81-3-3817-5120 
Copyright 2014 JCN Newswire. All rights reserved. www.japancorp.net 
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