Lenvatinib Phase III Results Show Significant Improvement In Progression-Free Survival In Patients With Radioiodine-Refractory Differentiated Thyroid Cancer
Phase III data for lenvatinib to be presented at ASCO

WOODCLIFF LAKE, N.J., May 31, 2014 /PRNewswire/ -- Eisai Inc. announced today results from the Phase III SELECT trial of investigational agent lenvatinib evaluating progression-free survival (PFS) in patients with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC). Progression-free survival with lenvatinib was extended significantly compared to placebo (HR=0.21, [99% CI: 0.14-0.31]; p<0.0001). The median PFS with lenvatinib and placebo were 18.3 months and 3.6 months, respectively. These data will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago as part of the ASCO press conference on May 31 and also in an oral session on Monday, June 2 (Abstract No. LBA6008).

Lenvatinib is an oral, multiple receptor tyrosine kinase inhibitor with a unique binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors, in addition to other proangiogenic and oncogenic pathway-related receptor tyrosine kinases involved in tumor proliferation. The SELECT study confirmed a statistically significant benefit for treatment with lenvatinib on PFS in all predefined subgroups. Secondary endpoints included overall response rate (ORR), overall survival (OS) and safety. The ORR for lenvatinib was significantly increased to 64.8 percent (95% CI: 59.0-70.5) compared to 1.5 percent (95% CI: 0.0-3.6; p<0.0001) in the placebo arm. Median OS has not been reached yet.

The five most common lenvatinib treatment-related adverse events (TRAEs) of any grade were hypertension (67.8%), diarrhea (59.4%), decreased appetite (50.2%), weight loss (46.4%) and nausea (41.0%). TRAEs of Grade 3 or higher (Common Terminology Criteria for Adverse Events) included hypertension (41.8%), proteinuria (10.0%), weight loss (9.6%), diarrhea (8.0%), and decreased appetite (5.4%).

"These results for lenvatinib in patients with treatment-refractory differentiated thyroid cancer are very encouraging," commented Lori Wirth, M.D., Study Investigator and Medical Director of the Center for Head and Neck Cancers at Massachusetts General Hospital. "Treatment options for radioiodine-refractory DTC are limited and there is a major unmet need for new therapies."  

Eisai was granted Orphan Drug Designation (ODD) for lenvatinib in various types of thyroid cancer in the United States, Japan, and Europe and will submit marketing authorization applications to those health authorities.

Eisai is committed to the therapeutic area of oncology and has an ongoing clinical trial program with lenvatinib in various tumor types.

About Lenvatinib 
Lenvatinib, discovered and developed by Eisai, is an oral, multiple receptor tyrosine kinase inhibitor with a unique binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1 [FLT1], VEGFR2 [KDR], and VEGFR3 [FLT4]), in addition to other proangiogenic and oncogenic pathway-related receptor tyrosine kinases (including fibroblast growth factor [FGF] receptors FGFR1, 2, 3, and 4; the platelet-derived growth factor [PDGF] receptor PDGFRα; KIT; and RET) involved in tumor proliferation. It is currently under investigation in thyroid, hepatocellular, endometrial and other solid tumor types.

SELECT Design Summary
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 117 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.

Patients were stratified by geographic region, prior VEGF/VEGFR targeted therapy (0 vs 1) and age (≤65 years vs >65 years) and randomized at a ratio of 2:1 to receive treatment with either lenvatinib 24 mg/day (administered orally, once a day) or placebo.

About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located inside the front of the lower neck. It is more common in women than in men and usually occurs between the ages of 25 and 65. Differentiated thyroid cancer is the most common type of thyroid cancer, including papillary and follicular, and accounts for approximately 95 percent of all cases. While most differentiated thyroid cancer patients are curable with surgery and radioactive iodine treatment, 10 percent of those patients will develop metastatic disease, of those patients 15 to 30 percent will become refractory to radioactive iodine. There are limited treatment options for this subset of patients.  

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 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 programs.

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.

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SOURCE Eisai Inc.

Type Press Release

Date Released May 31, 2014

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