Phase 3 Trial Shows Lenvatinib Meets Primary Endpoint of Progression Free
Survival in Radioiodine-Refractory Differentiated Thyroid Cancer
WOODCLIFF LAKE, N.J., Feb. 2, 2014
WOODCLIFF LAKE, N.J., Feb. 2, 2014 /PRNewswire/ --Eisai Inc. announced today
that the Phase 3 SELECT trial (Study 303) of investigational agent lenvatinib
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 preliminary safety analyses 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 the United
States, Japan, and Europe.
The SELECT (Study of E7080 LEnvatinib in Differentiated Cancer of the Thyroid)
study was a multicenter, randomized, double-blind, placebo-controlled Phase 3
study to compare the PFS of patients with radioiodine-refractory
differentiated thyroid cancer and radiographic evidence of disease progression
within the prior 12 months, treated with once-daily, oral lenvatinib (24mg)
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.
"These results show the potential role of the investigational drug lenvatinib
in this rare, hard-to-treat cancer," said Kenichi Nomoto, PhD, President,
Oncology Product Creation Unit, Eisai Product Creation Systems. "RR-DTC
remains an unmet need with a limited number of treatment options."
Lenvatinib, discovered and developed by Eisai, 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.
Eisai's ongoing global clinical trial program includes Phase 3 and Phase 2
studies in several other tumor types. Eisai is committed to the therapeutic
area of oncology and to understanding the potential clinical benefits of
lenvatinib in order to further contribute to patients and their families.
About Lenvatinib (E7080)
Lenvatinib is an oral inhibitor of select receptor tyrosine kinases (RTKs),
including VEGFR 1-3, FGFR 1-4, PDGFR-β, KIT and RET involved in angiogenesis
and tumor proliferation. It is currently under investigation as a potential
treatment for thyroid, hepatocellular, endometrial and other solid tumor
About Thyroid Cancer
Thyroid cancer is the most common endocrine malignancy and global figures show
that its incidence has increased significantly over the last 50 years. In the
United States, rates for new thyroid cancer cases have been rising 6.4 percent
each year over the past 10 years, with approximately 60,220 new cases in 2013.
Differentiated thyroid cancer accounts for approximately 90 percent of all
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to
patients and their families, and helping to increase the benefits health care
provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co.,
Ltd., we have a passionate commitment to patient care that is the driving
force behind our efforts to help address unmet medical needs. We are a fully
integrated pharmaceutical business with discovery, clinical, manufacturing and
marketing capabilities. Our key areas of commercial focus include oncology and
specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To
learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation
organization that includes R&D facilities in Massachusetts, New Jersey, North
Carolina and Pennsylvania, as well as a global demand chain organization that
includes manufacturing facilities in Maryland and North Carolina. Eisai's
global areas of R&D focus include neuroscience; oncology; metabolic disorders;
vascular, inflammatory and immunological reaction; and antibody-based
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that
discovers, develops and markets products across the world through a global
network of research facilities, manufacturing sites and marketing
subsidiaries. For more information about Eisai's global operations, please
About the SFJ Pharmaceuticals Group
The SFJ Pharmaceuticals Group, which includes SFJ Pharma Ltd., is a global
drug development company that 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.
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