ArQule and Daiichi Sankyo announced Phase 2 trial data withtivantinib as a single agent investigational second-line treatment inhepatocellular carcinoma (HCC).

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

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

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

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