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Arqule Inc And Daiichi Sankyo Co Ltd Announces Discontinuation Of Phase 3 MARQUEE Clinical Trial In Non-Small Cell Lung Cancer


Tuesday, 2 Oct 2012 07:30am EDT 

Arqule Inc and Daiichi Sankyo Co Ltd 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 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. ArQule and Daiichi Sankyo are providing information regarding the study discontinuation to health authorities and those clinical investigators participating in studies of tivantinib.