ArQule and Daiichi Sankyo move NSCLC drug ARQ 197 into Phase III clinical trial plan

USA-based ArQule and Japanese drug major Daiichi Sankyo say they will move forward with a Phase III clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer (NSCLC). In connection with this decision, the sponsor company, Daiichi Sankyo, will file a Special Protocol Assessment (SPA) with the US Food and Drug Administration for a trial comparing ARQ 197 plus erlotinib against erlotinib plus placebo.

'The decision to advance ARQ 197 into Phase III clinical testing underscores the success of our partnership with Daiichi Sankyo,' said Paolo Pucci, chief executive of ArQule. 'ArQule and Daiichi Sankyo signed the ARQ 197 partnership in December 2008, and in less than two years, we are requesting an SPA for a Phase 3 trial with this potential first-in-class molecule,' he added.

Encouraging efficacy seen with the drug