Lenvatinib Meets Primary Endpoint in Phase 3 SELECT Trial
Eisai announced that lenvatinib has met its primary endpoint in the Phase 3 SELECT trial (Study 303) for radioiodine-refractory differentiated thyroid cancer (RR-DTC). Lenvatinib showed a highly statistically significant improvement in progression free survival (PFS) in patients with RR-DTC compared to placebo.
Lenvatinib is an investigational small molecule tyrosine kinase inhibitor being studied as an oral agent in patients with radioiodine-refractory differentiated thyroid cancer (DTC). Lenvatinib inhibits select receptor tyrosine kinases (RTKs), including VEGFR 1-3, FGFR 1-4, PDGFR-β, KIT, and RET involved in angiogenesis and tumor proliferation.
The SELECT (Study of E7080 LEnvatinib in Differentiated Cancer of the Thyroid) study was a multicenter, randomized, double-blind, placebo-controlled Phase 3 study (n=392) to compare the PFS of patients with RR-DTC and radiographic evidence of disease progression within the prior 12 months, treated with once-daily lenvatinib 24mg vs. placebo. Secondary endpoints of the study included overall response rate (ORR), overall survival (OS), and safety.
Lenvatinib was granted Orphan Drug Designation for follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer.
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