Phase III METIV-HCC trial data for ARQ 197 (tivantinib) in hepatocellular carcinoma confirms phase II results- ArQule

ArQule announced that an analysis of preliminary baseline tumor MET status of patients screened in the phase III METIV-HCC trial for ARQ 197 (tivantinib) in second-line hepatocellular carcinoma (HCC) confirms previously presented data from the company’s phase II trial in the same patient population. In both trials MET status, as determined by immunohistochemistry, was more frequently high after first-line therapy and was a predictive and prognostic biomarker in the phase II trial.

The METIV-HCC trial screened patient tumor biopsies for MET status as an inclusion criteria for Met-high patients. Approximately half of the more than 1,000 samples tested were MET-high. A higher MET-high rate (73%) was observed in those samples from patients analyzed following first-line treatment with sorafenib while a lower MET-high rate (39%) was observed in those samples analyzed prior to sorafenib treatment. An additional analysis found that 70% (50 out of 71) of patients who tested MET-low before sorafenib treatment became MET-high after receiving sorafenib. The data was presented at the 2016 Gastrointestinal Cancers Symposium.