BioCentury
ARTICLE | Clinical News

ArQule discontinues second tivantinib trial in NSCLC

October 31, 2012 12:35 AM UTC

ArQule Inc. (NASDAQ:ARQL) said Asian partner Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) discontinued the Asian Phase III ATTENTION trial of tivantinib in non-small cell lung cancer (NSCLC) based on a recommendation by the trial's safety committee. In August, the partners suspended enrollment in the trial following an imbalance of interstitial lung disease between treatment arms. The trial was comparing tivantinib plus Tarceva erlotinib to Tarceva alone in 460 EGFR wild-type patients with locally advanced or metastatic, non-squamous NSCLC who received one to two prior systemic cancer therapies. ArQule said data from ATTENTION are expected in 2H13 (see BioCentury, Sept. 10).

Earlier this month, ArQule and its partner outside of Asia, Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568), discontinued the Phase III MARQUEE trial of tivantinib in NSCLC after an interim analysis showed tivantinib plus Tarceva would miss the primary endpoint of overall survival (OS) vs. Tarceva alone. (see BioCentury Extra, Oct. 2). ...