ArQule Announces Tivantinib Meets Primary Endpoint, Significantly Extending Time to Progression in Phase 2 Trial in Second-Line Hepatocellular Carcinoma

ArQule, Inc. (NASDAQ: ARQL) today announced that treatment with tivantinib as single agent therapy produced a statistically significant 56 percent improvement in time-to-progression in the intent-to-treat population, the primary endpoint in a randomized, controlled Phase 2 clinical trial in previously treated patients with hepatocellular carcinoma (hazard ratio = 0.64; log rank p-value = 0.04).

Adverse events were reported at similar rates in the treatment and placebo arms, except for a higher incidence of fatigue and hematologic events, including neutropenia and anemia, in tivantinib-treated patients. The incidence of hematologic events declined following dose reduction of tivantinib from 360 milligrams twice daily (BID) to 240 milligrams BID.

“These findings represent the first randomized data reported with a c-Met inhibitor administered as a single agent in HCC,” said Dr. Brian Schwartz, chief medical officer of ArQule. “Second line treatment for HCC remains a challenge, lacking an approved agent. We look forward to presenting complete data from this trial at a peer-reviewed forum later this year, including secondary endpoint, sub-group and biomarker analyses.”

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