Phase III Select Trial of Lenvatinib Meets Primary Endpoint of Improved Progression Free Survival in the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer

Phase III Select Trial of Lenvatinib MeetsPhase III Select Trial of Lenvatinib Meets Primary Endpoint of Improved Progression Free Survival in the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer PR Newswire HATFIELD, England, February 3, 2014 Eisai announced today that the Phase III SELECT trial (Study 303) of lenvatinib, an investigational selective tyrosine kinase inhibitor (TKI) with a [1]novel binding mode, 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, diarrhoea, decreased appetite, decreased weight and nausea. The SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) study was a multicentre, randomised, 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 (24mg) versus placebo. Secondary endpoints of the study included overall response rate (ORR), overall survival (OS) and safety. The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.