Phase 2 study of ARQ 197 for treatment of non-small cell lung cancer (NSCLC)

ArQule Incorporated announced results from its Phase 2 study of ARQ 197 for the treatment of patients with advanced, refractory non-small cell lung cancer (NSCLC). One hundred sixty-seven patients were evaluated in the Phase 2 trial. Participating patients were EGFR (epidermal growth factor receptor) inhibitor naïve and were randomized one-to-one to receive either the combination of ARQ 197 plus erlotinib or placebo plus erlotinib in second and third line settings.  Results from this study demonstrated that, ARQ 197, when used in combination with erlotinib, demonstrated a 66% improvement in median Progression-Free Survival (PFS) in patients with advanced NSCLC. In the intent to treat (ITT) population (n = 167), median PFS was 16.1 weeks in the ARQ 197 plus erlotinib arm, compared with 9.7 weeks in the erlotinib plus placebo arm.

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

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