Daiichi Sankyo and ArQule announced that the first patient has been enrolled in the Phase 3 trial of ARQ 197 in combination with erlotinib, for patients diagnosed with non-squamous, non-small cell lung cancer (NSCLC) who have received one or two prior systemic anti-cancer therapies. The trial is a randomized, double-blinded, controlled study of previously treated patients with locally advanced or metastatic, non-squamous NSCLC who will receive ARQ 197 plus erlotinib or placebo plus erlotinib. The primary objective is to evaluate the overall survival (OS) in the intent-to-treat (ITT) population. Secondary endpoints include OS in the subpopulation of patients with epidermal growth factor receptor (EGFR) wild type, progression-free survival (PFS) in the ITT population, and further assessment of the safety of ARQ 197 in combination with erlotinib.

ARQ 197 is an orally available, small molecule inhibitor of the c-Met receptor tyrosine kinase.

For more information call (781) 994-0300 or visit www.arqule.com.