ArQule and Daiichi Sankyo announced the presentation of data from a Phase 2 trial showing encouraging overall survival (OS) results with ARQ 197 in combination with erlotinib among patients with advanced, refractory non-small cell lung cancer (NSCLC).  One hundred sixty-seven patients participated in this Phase 2, double-blind, randomized, signal generation trial. All patients were EGFR (epidermal growth factor receptor) inhibitor-naïve, but had progressed after at least one prior chemotherapy regimen. Patients were randomized one-to-one to receive either the combination of ARQ 197 plus erlotinib or placebo plus erlotinib. The primary endpoint of the study was comparison of Progression-Free Survival (PFS) between treatment arms; secondary endpoints included PFS in pre-defined patient subsets, overall survival, overall response rate, and safety.  Data from the study showed that median OS in the intent to treat (ITT) population (n = 167) was 36.6 weeks in the ARQ 197 plus erlotinib arm, compared with 29.4 weeks in the erlotinib plus placebo arm, an improvement of 24 percent (unadjusted hazard ratio = 0.88, p = 0.50) as one of the secondary endpoints. In the pre-defined sub-group of patients with non-squamous cell carcinoma histology (n = 117), median OS was 43.1 weeks in the treatment arm, compared with 29.4 weeks in the placebo arm, an improvement of 47 percent (unadjusted hazard ratio = 0.72, p = 0.19).

As previously announced, the ARQ 197 plus erlotinib combination demonstrated a 66 percent improvement in the primary endpoint, median Progression-Free Survival (PFS), although the difference in PFS between the two arms did not achieve statistical significance (p = 0.24, hazard ratio = 0.81) by applying a log-rank test. Improvement in median PFS was more pronounced in the pre-defined sub-group of patients with non-squamous histology (n = 117).

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.