Daiichi Sankyo and biotechnology company ArQule have enrolled the first patient in a double-blinded, controlled, pivotal Phase III clinical study of its investigational selective inhibitor of MET, a receptor tyrosine kinase.
The MET inhibitor drug, tivantinib (ARQ 197), is designed to treat hepatocellular carcinoma (HCC), a disease leading to primary liver cancers.
The start of the pivotal study follows positive results from a Phase II study of tivantinib, which demonstrated improvements in overall survival and time to progression among MET-high patients.
The Phase III clinical study, METIV-HCC (MET-high patients with tivantinib in HCC), will enrol 300 patients with HCC who have received one or two prior systemic anti-cancer therapies.
The study, which includes previously treated patients with MET-high inoperable HCC, will randomise participants to receive treatment either with tivantinib or placebo.
The primary endpoint of the study is overall survival, while the secondary endpoint is progression-free survival (PFS).
Daiichi Sankyo senior executive officer and research and development global head Glenn Gormley said; "It is our hope that this late-stage study will confirm the positive results we saw in Phase II in time to progression (TTP) and overall survival (OS) observed in patients whose tumors were MET-high."
The partnership between the companies forms part of a licence, co-development and co-commercialisation agreement, signed in December 2008, for tivantinib in the US, Europe and South America.
An agreement was also reached with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the pivotal Phase III trial.