Show simple item record

dc.contributor.authorCalifano, Raffaele
dc.contributor.authorCamidge, D.
dc.contributor.authorKim, H. R.
dc.contributor.authorAhn, M. J.
dc.contributor.authorYang, J.
dc.contributor.authorHan, J. Y.
dc.contributor.authorHochmair, M.
dc.contributor.authorLee, K. H.
dc.contributor.authorDelmonte, A.
dc.contributor.authorCampelo, M. R. G.
dc.contributor.authorKim, D. W.
dc.contributor.authorGriesinger, F.
dc.contributor.authorFelip, E.
dc.contributor.authorSpira, A.
dc.contributor.authorGettinger, S.
dc.contributor.authorTiseo, M.
dc.contributor.authorNi, Q.
dc.contributor.authorZhang, P.
dc.contributor.authorPopat, S.
dc.date.accessioned2021-01-06T11:15:16Z
dc.date.available2021-01-06T11:15:16Z
dc.date.issued2020en
dc.identifier.citationCalifano R, Camidge D, Kim HR, Ahn MJ, Yang J, Han JY, et al. Brigatinib versus crizotinib in patients with ALK inhibitor-naive advanced ALK plus NSCLC: results from the phase 3 ALTA-1L trial. Lung Cancer. 2020;139:S59-S60en
dc.identifier.urihttp://hdl.handle.net/10541/623584
dc.description.abstractIntroduction: We report results of the first interim analysis from the ALTA-1L study of brigatinib vs crizotinib in ALK TKI–naive, ALK+ NSCLC (NCT02737501). Methods: This open-label, multicenter study enrolled patients with stage IIIB/IV ALK+ NSCLC based on local ALK testing (FDA approved/ other). Eligible patients had ECOG PS 0–2, ≤1 prior systemic therapy for locally advanced/metastatic NSCLC, and no prior ALK inhibitor. Asymptomatic CNS metastases were allowed. All patients had systematic CNS imaging. 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 objective response rate (ORR), intracranial ORR (iORR), and intracranial PFS (iPFS). Interim analyses were planned at 50% and 75% of planned PFS events (n=198). Results: 275 patients were randomized (brigatinib/crizotinib, n=137/138); median age (years) 58/60. 26%/27% received prior chemotherapy for advanced disease, and 29%/30% had baseline brain metastases. At data cutoff (19 February 2018), median followup brigatinib/crizotinib: 11.0/9.25 months; with 99 PFS events, brigatinib met the prespecified threshold for statistical superiority vs crizotinib in the primary endpoint, BIRC-assessed PFS (HR 0.49, 95% CI 0.33–0.74, log-rank p=0.0007); brigatinib mPFS was not reached (95% CI NR–NR) vs crizotinib 9.8 months (95% CI 9.0–12.9). Investigator-assessed PFS HR 0.45 (95% CI 0.30–0.68), log-rank p=0.0001. Table 1 shows additional efficacy data. Most common treatment-emergent AEs grade ≥3: brigatinib: increased CPK (16.2%), increased lipase (13.2%), hypertension (9.6%); crizotinib: increased ALT (9.5%), AST (5.8%), and lipase (5.1%). Any grade ILD/ pneumonitis: brigatinib, 3.7%; crizotinib, 2.2%. Discontinuations due to AE (brigatinib/crizotinib): 11.8%/8.8%. Updated data from the second interim analysis will be presented. Conclusion: Brigatinib showed a statistically and clinically significant improvement in PFS vs crizotinib in ALK inhibitor–naive ALK+ NSCLC.en
dc.language.isoenen
dc.titleBrigatinib versus crizotinib in patients with ALK inhibitor-naive advanced ALK plus NSCLC: results from the phase 3 ALTA-1L trialen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentThe Christie NHS Foundation Trust, Manchesteren
dc.identifier.journalLung Canceren
dc.description.noteen]


This item appears in the following Collection(s)

Show simple item record