Singapore: Biotech company ArQule and Japan-based Daiichi Sankyo have achieved positive results from a randomized, placebo controlled, double-blind, phase II clinical trial with the selective MET inhibitor tivantinib as a single-agent, investigational, second-line treatment of hepatocellular carcinoma (HCC). Tivantinib is an orally administered, selective inhibitor of MET, a receptor tyrosine kinase.

The 107 patients in the trial had unresectable HCC and had disease progression after first-line therapy or were unable to tolerate the first-line therapy.

"Patients living with this disease need more options to slow progression. The findings from this tivantinib study represent the first randomized data reported in HCC with an investigational MET inhibitor, as single-agent therapy in second-line treatment," said Lorenza Rimassa, deputy director, Medical Oncology Unit, Humanitas Cancer Center, Milan, Italy. "The data suggest that patients significantly benefited in time to progression and, importantly, those in a biologically relevant MET-high subgroup had an additional significant advantage in overall survival."

"Research has shown that MET is a signaling pathway associated with poor outcomes in many cancers, including liver cancer and non-small cell lung cancer (NSCLC)," said Dr Glenn Gormley, global head of Research & Development and senior executive Officer, Daiichi Sankyo. "The strong overall survival results among HCC patients in this trial whose tumors were MET-high reinforce this previous research that defines MET as a critical pathway in cancer as well as the activity of tivantinib as a MET inhibitor."