Tivantinib: Phase III discontinued

ArQule and Asian partner Kyowa discontinued the double-blind, Asian Phase III ATTENTION trial of tivantinib based on a recommendation by the trial's safety committee. ATTENTION was comparing tivantinib plus Tarceva erlotinib vs. Tarceva alone in 460 EGFR wild-type patients with locally advanced or metastatic, non-squamous NSCLC who received 1-2 prior systemic cancer therapies. In August, the partners suspended enrollment in the trial following an imbalance of interstitial lung disease between treatment arms. ArQule said data from ATTENTION are expected in 2H13 (see BioCentury, Sept. 3).

Last month, ArQule and its partner outside of Asia, Daiichi Sankyo, discontinued the Phase III MARQUEE trial of tivantinib in NSCLC after an interim analysis showed tivantinib plus Tarceva would miss the primary endpoint of OS vs. Tarceva alone (see BioCentury, Oct. 8). ArQule plans to start by year end or early next year a Phase III trial to evaluate the product for hepatocellular carcinoma (HCC). 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 next year. ...