Abstract
2501 Background: The anaplastic lymphoma kinase (ALK) fusion gene is a key oncogenic driver in a subset of patients with NSCLC. Crizotinib is a potent and selective, ATP-competitive, small molecule ALK inhibitor. Patients with ALK-positive NSCLC may benefit from targeted ALK inhibitors. Methods: An ongoing open-label, multicenter, 2-part, phase I trial is investigating the safety, tolerability, pharmacokinetics, and antitumor activity of crizotinib in patients with advanced cancer. Updated safety and response data and preliminary PFS data from an expanded ALK-positive cohort of patients with NSCLC in part 2 of the study are reported. Patients received oral crizotinib 250 mg BID in 28-day cycles. Results: Currently, 119 patients with ALK-positive NSCLC have enrolled and 116 are evaluable for response, with 94 in follow-up for survival. Median age was 51 years; patients were usually never- or former-smokers (99%) with adenocarcinoma histology (97%). Most patients were heavily pretreated, with 44% receiving ...
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