Plasma Genotyping Of Patients Enrolled On The Expansion Phase Vii Trial Of X-396 In Patients (Pts) With Alk Plus Non-Small Cell Lung Cancer (Nsclc).

9056Background: X-396 is a novel, potent anaplastic lymphoma kinase (ALK) small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK. We report data on ALK TKI-naive and crizotinib (C)-resistant NSCLC pts treated with X-396. Methods: In this multicenter expansion study, pts with ALK+ NSCLC were treated with X-396 225 mg daily on a 28-day schedule. Pts had measurable disease, ECOG PS 0-1, untreated brain metastases (CNS) and leptomeningeal disease were allowed. NGS on plasma samples was performed at baseline and on study and compared with central tissue results (FISH/IHC). All pts were assessed for response to therapy using RECIST 1.1, adverse events (AEs) using CTCAE version 4.03 were recorded. Results: 60 pts (53% female) have been enrolled. Median age 56 (20-79) years, 67% ECOG PS 1. Of 30 ALK+ NSCLC pts evaluable for response; partial response (PR) was achieved in 19 pts (60%) and stable disease (SD) in 2 pts (7%). In the C-naive pts (n = 8),...