ARTICLE | Clinical News

Tivantinib misses PFS endpoint in Japanese Ph III for HCC

May 5, 2017 7:59 PM UTC

ArQule Inc. (NASDAQ:ARQL) and partner Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) reported top-line data from the Phase III JET-HCC trial to treat hepatocellular carcinoma (HCC) showing that once-daily 120 mg oral tivantinib (ARQ 197) missed the primary endpoint of improving progression-free survival (PFS) vs. placebo. The double-blind, Japanese trial enrolled about 190 patients with c-Met receptor tyrosine kinase (c-MET; MET; HGFR; c-Met proto-oncogene)-high inoperable HCC who were resistant or intolerant to 1 systemic chemotherapy regimen that included Nexavar sorafenib. Secondary endpoints in the trial include overall survival (OS) and safety...