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news.ArQule, along with its partner Daiichi Sankyo, has entered into a Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA) for the design of a Phase 3 trial of ARQ 197 in patients with non-small cell lung cancer (NSCLC) of non-squamous histology.
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Daiichi Sankyo, the holder of the investigational new drug application for ARQ 197 and ArQule’s partner for the development of the compound, will conduct the Phase 3 trial, which is planned for initiation later this year.
The trial will be a randomized, double-blinded study of erlotinib plus ARQ 197 in patients with locally advanced or metatstatic NSCLC of non-squamous histology.
ARQ 197 is a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, and erlotinib is an inhibitor of epidermal growth factor receptor.
The primary endpoint is overall survival in the intent-to-treat population. Key secondary objectives include overall survival in the epidermal growth factor receptor wild-type sub-population and progression-free survival in the intent-to-treat population.
In December 2008, ArQule and Daiichi Sankyo have signed a license, co-development and co-commercialisation agreement to co-develop ARQ 197 in the US, Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.