ArQule and Daiichi Sankyo Announce Completion of Patient Recruitment in Phase 3 Clinical Trial of Tivantinib in Non-Small Cell Lung Cancer

ArQule, Inc. ARQL and Daiichi Sankyo, Co., Ltd. (TSE 4568) today announced that recruitment of patients has been completed in the randomized, double-blind, controlled Phase 3 MARQUEE pivotal trial of their investigational selective c-MET inhibitor, tivantinib, in combination with erlotinib in previously treated patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). The MARQUEE (Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC) trial began enrollment in January 2011 and is being conducted under a Special Protocol Assessment (SPA), which was established following agreement with the U.S. Food and Drug Administration (FDA). Tivantinib is currently in Phase 3 development and has not yet been approved for any indication.