Eisai has announced 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 in patients with radioiodine-refractory differentiated thyroid cancer ( RR-DTC ).
The preliminary safety analyses have 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 progression-free survival 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, and safety.
The study enrolled 392 patients at over 100 sites in Europe, North and South America and Asia.
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. ( Xagena )
Source: Eisai, 2014