Efficacy and safety of crizotinib in patients with advanced c-MET-amplified non-small cell lung cancer (NSCLC).

8001 Background: c-Met-amplified NSCLC defines a subset of NSCLC that may be sensitive to the small-molecule tyrosine kinase inhibitor crizotinib, approved multinationally for the treatment of advanced ALK-positive NSCLC. Efficacy and safety data are presented for crizotinib in patients with advanced c-Met-amplified NSCLC within 3 categories of amplification MET/CEP7 ratio ≥1.8-≤2.2 (Low), >2.2-<5 (Intermediate) and ≥5 (High). Methods: c-METamplification status was determined by FISH, with 10-12 patients to be enrolled into each amplification category. If 2 or more objective responses occur in a category, 19 additional patients are to be enrolled. This study is part of an ongoing phase 1 crizotinib study (NCT00585195). Patients received crizotinib 250 mg BID. Responses were assessed using RECIST v1.0. Results: At data cut-off, 16 patients were enrolled; 3 were subsequently determined not to have an amplification meeting MET/CEP7 criteria. 13 patients with c-MET-amplified NSCLC [Low (n=1), Intermediate (n=...