METIV-HCC phase III study of ARQ 197 (tivantinib) in hepatocellular carcinoma fails to meet endpoint- ArQule and Daiichi Sankyo
ArQule and Daiichi Sankyo announced that the METIV-HCC phase III study of ARQ 197 (tivantinib) in hepatocellular carcinoma (HCC) did not meet its primary endpoint of improving overall survival. METIV-HCC is a biomarker-selected, double-blind, placebo-controlled, randomized phase III study evaluating tivantinib (2:1) versus best supportive care in patients with MET-overexpressing, inoperable HCC intolerant to or previously-treated with systemic therapy.
A total of 340 patients with MET-overexpressing HCC analyzed by a validated immunohistochemical assay were randomized in the intent-to-treat population for efficacy analysis. The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival and safety. Full results from the trial will be presented at an upcoming scientific forum.
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