Tivantinib: SPA received

ArQule said it reached an agreement with FDA on an SPA for a double-blind, international Phase III trial to evaluate tivantinib in about 300 previously treated patients with high inoperable HCC that is positive for c-Met based on a diagnostic. ArQule is co-developing tivantinib with Daiichi Sankyo on a worldwide basis outside of certain Asian countries, where ArQule licensed rights to Kyowa in 2007 (see BioCentury, April 30, 2007 & Nov. 17, 2008).

Earlier this month, ArQule and Daiichi Sankyo discontinued the double-blind, international Phase III MARQUEE trial in about 1,000 non-small cell lung cancer (NSCLC) patients after a planned interim analysis by an independent DMC showed that twice-daily 360 mg oral tivantinib plus Tarceva erlotinib would miss the primary endpoint of OS vs. placebo plus Tarceva. The partners had an SPA from FDA for the trial (see BioCentury, Oct. 8). Tivantinib has also completed Phase II trials in gastric cancer, and data from a Phase II trial of tivantinib to treat colorectal cancer are expected by year end or early 2013. ...