ArQule, Daiichi discontinue Phase 3 MARQUEE trial

The trial was discontinued following the independent Data Monitoring Committee recommendation after conducting a planned interim analysis.

The interim analysis, which identified no safety concerns, showed the study would not meet its primary endpoint of improved overall survival.

ArQule chief executive officer Paolo Pucci said, "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."

In December 2008, ArQule and Daiichi entered into an agreement to co-develop tivantinib in the US, Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.

Daiichi Sankyo senior executive officer and R&D global head Glenn Gormley said, "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."