ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo, Co., Ltd. (TSE 4568) today announced that the independent Data Monitoring Committee (DMC) of the Phase 3 MARQUEE ( Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC) trial recommended the study be stopped early following a planned interim analysis, when they concluded that the study would not meet its primary endpoint of improved overall survival. Although the interim analysis showed a statistically significant improvement in progression-free survival (PFS) in the intent-to-treat (ITT) population, this benefit did not carry over to overall survival. There were no safety concerns identified by the DMC to Daiichi Sankyo or ArQule during this interim analysis. MARQUEE is a randomized, double-blind, controlled pivotal trial to evaluate the investigational selective MET inhibitor, tivantinib (ARQ 197), in combination with erlotinib in previously treated patients with locally advanced or metastatic, non-squamous NSCLC. ArQule and Daiichi Sankyo are providing information regarding the study discontinuation to health authorities and those clinical investigators participating in studies of tivantinib. Data from this study will be presented at an upcoming scientific meeting. “We are disappointed that the MARQUEE trial did not provide statistically significant results for overall survival in a disease and treatment setting which remains a major unmet medical need,” said Paolo Pucci, chief executive officer of ArQule. “Fighting cancer is a complex process in that therapies work differently in different tumor settings, so we will continue to investigate tivantinib in other tumor types,” said Glenn Gormley, MD, PhD, global head, R&D and senior executive officer, Daiichi Sankyo Co., Ltd. Approximately 1,000 patients were recruited in MARQUEE from more than 200 clinical sites worldwide. The primary endpoint in the trial is overall survival (OS) in the overall intent-to-treat population. Secondary endpoints include OS in the subpopulation of patients with epidermal growth factor receptor (EGFR) wild type, progression-free survival (PFS) in the ITT population, and further assessment of the safety of tivantinib in combination with erlotinib. Tivantinib has not been approved for any indication in any country.