BioCentury
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ArQule slides on trial discontinuation

October 3, 2012 12:27 AM UTC

ArQule Inc. (NASDAQ:ARQL) fell $2.81 (56%) to $2.18 on Tuesday after it and Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) discontinued the Phase III MARQUEE trial in non-small cell lung cancer after an interim analysis showed tivantinib plus Tarceva erlotinib would miss the primary endpoint of overall survival (OS) vs. Tarceva alone. The partners said that tivantinib plus Tarceva significantly improved progression-free survival (PFS), a secondary endpoint, vs. Tarceva alone. No safety concerns were identified with the small molecule inhibitor of c-Met receptor tyrosine kinase. The trial enrolled about 1,000 patients with locally advanced or metastatic, non-squamous NSCLC who received 1-2 prior systemic cancer therapies.

ArQule and Daiichi Sankyo plan to 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 Hakko Kirin Co. Ltd. (Tokyo:4151) suspended enrollment in the 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 NSCLC patients. At June 30, ArQule had $75.1 million in cash and short-term marketable securities, with a 1H12 operating loss of $5.4 million (see BioCentury, Sept. 10). ...