L. Sequist, J. Goldman, H. Wakelee
May 20, 2015
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Influential Citations
55
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Journal
Journal of Clinical Oncology
Abstract
8001 Background: Rociletinib is an oral inhibitor of mutant EGFR, including the T790M resistance mutation. We reported robust activity in T790M positive pts identified by tumor genotyping treated at 500mg-1000mg BID (active doses) [NCT01526928]. We now present data from the pt subset with T790M detected by plasma genotyping. Methods: For the overall phase 1/2 study, pts had EGFR-mutant NSCLC and treatment with ≥ 1 EGFR inhibitor, ECOG PS 0-1. Brain metastases were allowed. In phase 2, T790M pos by central tumor genotyping was required. Plasma EGFR status was assessed by BEAMing (Sysmex), a quantitative assay using emulsion PCR then flow cytometry. Results: 345 pts were enrolled at active doses, median age 62 yrs, 66% female, 69% ECOG 1, 87% from US sites, median prior therapies 3 (45% ≥ 2 prior TKIs). Response data are available for 219 with tissue genotyping and 113 with plasma genotyping. The RECIST objective response rate (ORR) was ~48% in T790M pos pts, regardless of genotyping method. ORR was 33-36% ...