DMC Recommends ArQule (ARQL), Daiichi Sankyo Discontinue Phase 3 MARQUEE Trial
Tweet Send to a FriendGet Alerts ARQL Hot Sheet
Up)
Trade ARQL Now!
ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo, Co., Ltd. (TSE 4568) 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.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
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.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Sanofi (SNY), Regeneron (REGN) Report Publication of Positive Dupilumab Phase 2a Data
- Novo Nordisk (NVO) Reports Positive Results from Paradigm 2
- Sanofi (SNY) Reports JAKARTA Met Primary Endpoint in Both Groups
Create E-mail Alert Related Categories
FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
