Phase 2 Trial Update of Tivantinib for Hepatocellular Carcinoma

ArQule and Daiichi Sankyo announced Phase 2 trial data with tivantinib as a single agent investigational second-line treatment in hepatocellular carcinoma (HCC).

Data from the trial demonstrated a statistically significant improvement in time-to-progression (HR=0.43, log rank P-value=0.03), accompanied by significant improvements in progression-free survival and disease control rate among second-line patients with c-MET high tumors who were treated with tivantinib. In addition, overall survival data were observed favoring tivantinib-treated patients in this population. Efficacy was similar in the two tivantinib dosing subgroups (360mg twice daily and 240mg twice daily), with less frequent neutropenia in the lower dose.

Previously announced top-line data from the trial demonstrate that treatment with tivantinib produced a statistically significant 56% improvement in TTP in the intent-to-treat (ITT) population by central radiology review, the primary endpoint (HR=0.64, log rank P-value=0.04) in this trial.

Tivatinib is an orally available, selective inhibitor of c-Met, a receptor tyrosine kinase.

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