OA0207 Phase 3 ALUR Study of Alectinib in Pretreated ALK+ NSCLC: Final Efficacy, Safety and Targeted Genomic Sequencing Analyses

The ALUR (NCT02604342) primary analysis (cut-off January 2017) demonstrated improved efficacy and safety with alectinib versus chemotherapy in patients with ALK+ NSCLC previously treated with chemotherapy and crizotinib. These patients can develop crizotinib resistance through ALK secondary mutations, but limited data exist regarding alectinib’s efficacy in patients with different post-crizotinib genetic profiles. We report final data from ALUR including treatment outcomes according to genetic profile. Overall, 119 patients with locally determined ALK+ NSCLC were randomised 2:1 to receive alectinib 600mg bid or chemotherapy (pemetrexed 500mg/m2 or docetaxel 75mg/m2 q3w). The primary endpoint was PFS by investigator. Targeted genomic sequencing (FoundationONE® [tissue; 315 genes] and FoundationACT® [plasma; 62 genes]) was performed retrospectively using tumour tissue (n=33) and baseline plasma (n=59). Final data from ALUR confirm the primary analysis, demonstrating improved efficacy and..... READ ARTICLE

Journal of Thoracic Oncology DOI:10.1016/j.jtho.2019.08.416

Authors: J. Wolf, Å. Helland, I. Oh, M.R. Migliorino, R. Dziadziuszko, J. De Castro Carpeno, J. Mazieres, F. Griesinger, M. Chlistalla, A. Cardona, T. Ruf, K. Trunzer, V. Smoljanovic, S. Novello