Phase II study of lenvatinib in patients with differentiated, medullary, and anaplastic thyroid cancer: Final analysis results.

6088Background: Thyroid cancer is classified into differentiated (DTC), medullary (MTC), and anaplastic (ATC) types. Lenvatinib (LEN) significantly prolonged progression-free survival (PFS) vs placebo in the phase III SELECT trial of patients (pts) with 131I-refractory DTC (RR-DTC). Initial results of this phase 2 trial (Study 208) of LEN in RR-DTC, MTC, and ATC were reported with a cutoff date of 15 Jun 2014. Here we report the final results of this study. Methods: This was a single-arm, open-label, phase 2 study conducted in Japan with an updated data cutoff of 9 Jul 2015. Pts received LEN 24 mg/d in 28-d cycles until progressive disease or development of unacceptable toxicity. Primary endpoint was safety; secondary endpoint was efficacy as assessed by PFS, overall survival (OS), overall response rate (ORR), and disease control rate (DCR). Results: 51 Pts, including 25 pts with RR-DTC (previously 23), 9 pts with MTC, and 17 pts with ATC (previously 11) were enrolled. All pts had at least one treatment-e...