METIV-HCC tivantinib phase 3 trial completes enrollment for HCC

ArQule, Inc. and Daiichi Sankyo, Inc. announced that enrollment of the phase 3 METIV-HCC clinical trial investigating tivantinib for the treatment of hepatocellular carcinoma is complete.

METIV-HCC is a double-blind, placebo controlled trial and will include at least 300 patients with HCC and MET-high tumors randomly assigned a treatment regimen of tivantinib (ARQ 197, ArQule) — a selective inhibitor of the c-Met receptor, tyrosine kinase — or to supportive care for comparison. The primary endpoint of the trial is overall survival.

“We are pleased to have fully accrued the METIV-HCC trial prior to year-end,” Brian

Schwartz, MD, head of research and development and chief medical officer at ArQule Inc., said in the release. “HCC is a disease with high unmet need and with no approved therapy for second-line treatment. It has been very encouraging to see a growing body of evidence supporting the phase 3 clinical evaluation of tivantinib in MET-high populations through a recent presentation at the International Liver Cancer Association conference.”

The trial is currently being conducted in Western countries.

Disclosure: Schwartz is employed by ArQule, Inc.