Tivantinib: Phase III discontinued

ArQule and Daiichi Sankyo discontinued the double-blind, international Phase III MARQUEE trial in about 1,000 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 did say that tivantinib plus Tarceva significantly improved PFS, a secondary endpoint, vs. placebo plus Tarceva. No safety concerns were identified. The trial enrolled patients with locally advanced or metastatic, non-squamous NSCLC who received 1-2 prior systemic cancer therapies. The partners had an SPA from FDA for the trial.

ArQule and Daiichi Sankyo said they will continue to investigate tivantinib in other tumor types. Data from a Phase II trial of tivantinib to treat colorectal cancer are expected by year end or early 2013. The compound has also completed Phase II trials in gastric cancer and hepatocellular carcinoma (HCC). ArQule plans to start a Phase III trial in HCC by year end or early 2013. In August, partner Kyowa suspended enrollment in the double-blind, Asian Phase III ATTENTION trial of tivantinib following an imbalance of interstitial lung disease between treatment arms. ATTENTION is comparing tivantinib plus Tarceva to Tarceva alone in 460 wild-type EGFR patients with locally advanced or metastatic, non-squamous NSCLC who received 1-2 prior systemic cancer therapies. ...