Methods: This open-label, multicenter study enrolled patients with advanced ALK+ NSCLC who had ≤ 1 prior systemic therapy; asymptomatic CNS metastases were allowed. Patients were randomized 1 : 1 to brigatinib 180 mg QD with 7-day lead-in at 90 mg or crizotinib 250 mg BID. Primary endpoint: blinded independent review committee (BIRC)-assessed PFS (RECIST v1.1). Secondary efficacy endpoints included BIRC-assessed ORR, intracranial (i) ORR (iORR), and PFS (iPFS). Interim analyses were planned at 50% and 75% of 198 expected PFS events. Results: 275 patients were randomized (brigatinib/crizotinib, n = 137/138); median age: 58/60 y. 26%/27% received prior chemotherapy for advanced disease; 29%/30% had baseline brain metastases. At data cutoff (19 Feb 2018) for the first interim analysis, median follow-up of brigatinib/crizotinib was 11.0/9.25 mo. With 99 PFS events, brigatinib met the prespecified threshold for statistical superiority vs. crizotinib in the primary endpoint, BIRC-assessed P..... READ ARTICLE
Pneumologie DOI:10.1055/s-0039-3403360
Authors: MJ Hochmair , DR Camidge , HR Kim , MJ Ahn , JCH Yang , J Youn Han , KH Lee , A Delmonte , MR Garcia Campelo , DW Kim , F Griesinger , E Felip , R Califano , A Spira , S Gettinger , M Tiseo , Q Ni , P Zhang , S Popat
