Abstract
9060Background: BRG is an investigational, selective ALK inhibitor with potent preclinical activity against native ALK and a broad set of mutants associated with clinical resistance to CRZ. BRG has shown promising efficacy in ALK rearranged (+) NSCLC pts previously treated with CRZ in a phase (Ph) 1/2 trial. We examined the association between BRG efficacy and ALK mutation status using tumor specimens collected after CRZ and prior to BRG treatment (tx) (baseline [BL]), and after BRG tx (Post-BL) in pts enrolled in the Ph1/2 trial and a Ph2 trial of ALK+ NSCLC pts whose disease progressed on CRZ (ALTA). Methods: Samples analysis: FoundationOne next-generation sequencing (NGS) platform. BRG activity: best response (RECIST v1.1) from BL. Data reported: Jan, 2016 for sample analyses, Nov and Dec, 2015 for Ph1/2 and ALTA clinical results, respectively. Results: Of the 301 ALK+ NSCLC pts enrolled in the Ph1/2 (N = 79) and ALTA (N = 222) trials, evaluable tumor samples were obtained from 30 pts at BL. Confirmed ...
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