ArQule announced results from its Phase 2 clinical trial of tivantinib in patients with previously-treated hepatocellular carcinoma (HCC). Patients were initially randomized to receive tivantinib 360mg twice daily or placebo. Due to neutropenia, the tivantinib dose was later reduced to 240mg twice daily for all patients.
As single-agent therapy, tivantinib produced a statistically significant 56% improvement in time-to-progression (TTP) in the intent-to-treat (ITT) population, the study’s primary endpoint (HR=0.64; log-rank P=0.04). The incidence of hematologic events declined following dose reduction of tivatinib from 360mg twice daily to 240mg twice daily.
Tivatinib is an orally available, selective inhibitor of c-Met, a receptor tyrosine kinase.
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