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.
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Lenvatinib was granted Orphan Drug Designation for follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer.
For more information call (888) 422-4743 or visit Eisai.com/US.
This article originally appeared on MPR
