ARQ 197 Phase III trial MARQUEE for NSCLC is stopped

ArQule, Inc. and Daiichi Sankyo, Co., Ltd. have announced that the independent Data Monitoring Committee (DMC) of the Phase III 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.