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ArQule, Inc. and Daiichi Sankyo Co., Ltd. Announce Positive Phase 2 Study Results for Tivantinib in Previously Treated Hepatocellular Carcinoma


Saturday, 2 Jun 2012 07:00am EDT 

ArQule, Inc. and Daiichi Sankyo Co., Ltd. announced final results from a randomized, placebo-controlled, double-blind, phase 2 clinical trial with the selective MET inhibitor tivantinib as a single-agent, investigational, second-line treatment in hepatocellular carcinoma (HCC). The 107 patients in the trial had unresectable HCC and had disease progression after first-line therapy or were unable to tolerate the first-line therapy. Patients were randomized to receive tivantinib at 360 milligrams (mg) twice daily or 240 mg twice daily or placebo. The primary endpoint was time to progression (TTP) in the intent to treat (ITT) population. Other study endpoints were disease control rate (DCR), progression free survival (PFS), overall survival (OS), as well as safety for the ITT population and pre-defined MET-high or MET-low cohorts (as defined by immunohistochemistry). A statistically significant 56% improvement as compared to placebo was seen in TTP in the ITT population (hazard ratio [HR] = 0.64; log rank p-value = 0.04). In the MET-high cohort, there were also statistically significant improvements in TTP, PFS and OS: Median OS in tivantinib arm was 7.2 months and 3.8 months in the placebo arm (HR = 0.38; log rank p-value = 0.01); Median TTP was 2.9 months in the tivantinib arm and 1.5 months in the placebo arm (HR = 0.43, log rank p-value = 0.03); and Median PFS was 2.4 months in the tivantinib arm and 1.5 months in the placebo arm (HR = 0.45, log rank p-value = 0.02).