OREANDA-NEWS. Daiichi Sankyo Company, Limited and ArQule, Inc. announced that the first patient has been enrolled in the pivotal Phase 3 METIV-HCC (MET-high patients with tivantinib in HCC) trial of tivantinib (ARQ 197). 

Tivantinib, an investigational selective inhibitor of MET, a receptor tyrosine kinase, is being evaluated for the treatment of patients diagnosed with hepatocellular carcinoma (HCC) who have received one or two prior systemic anti-cancer therapies.

The METIV-HCC trial is a randomized, double-blinded, controlled study of previously treated patients with MET-high inoperable HCC who will receive tivantinib or placebo.  The primary endpoint is overall survival (OS), and the secondary endpoint is progression-free survival (PFS).  Approximately 300 patients are planned to be enrolled at approximately 120 clinical centers worldwide. 

In October 2012, agreement was reached with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this pivotal Phase 3 trial.  The SPA process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a New Drug Application.  Final marketing approval depends on the results of the trial.