An exploratory biomarker analysis evaluating the effect of the c-MET inhibitor tivantinib (ARQ 197) and erlotinib in NSCLC patients in a randomized, double-blinded phase 2 study: Abstract number 1729.
[This significantly increases the chance of success for the ongoing phase 3 trial ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer]
An exploratory immunohistochemistry (IHC) analysis was conducted of archival tissue from a concluded Phase 2 clinical trial with tivantinib and erlotinib in NSCLC. Findings confirmed that in this trial non-squamous NSCLC tumors were more often positive for c-MET expression than squamous NSCLC tumors. In this study, 76 percent of evaluable patients with non-squamous tumors were c-MET positive, and 12 percent of evaluable patients with squamous tumors were c-MET-positive, a percentage that is consistent with existing literature.
Data analysis showed that treatment with the combination of tivantinib and erlotinib improved progression-free survival (HR = 0.58, p = 0.28) and overall survival (HR = 0.46, p = 0.21) in patients with non-squamous histology and c-MET-positive tumors, as measured by IHC, compared with patients who received with erlotinib plus placebo.