Brigatinib versus crizotinib in patients with ALK inhibitor-naive advanced ALK plus NSCLC: results from the phase 3 ALTA-1L trial
dc.contributor.author | Califano, Raffaele | |
dc.contributor.author | Camidge, D. | |
dc.contributor.author | Kim, H. R. | |
dc.contributor.author | Ahn, M. J. | |
dc.contributor.author | Yang, J. | |
dc.contributor.author | Han, J. Y. | |
dc.contributor.author | Hochmair, M. | |
dc.contributor.author | Lee, K. H. | |
dc.contributor.author | Delmonte, A. | |
dc.contributor.author | Campelo, M. R. G. | |
dc.contributor.author | Kim, D. W. | |
dc.contributor.author | Griesinger, F. | |
dc.contributor.author | Felip, E. | |
dc.contributor.author | Spira, A. | |
dc.contributor.author | Gettinger, S. | |
dc.contributor.author | Tiseo, M. | |
dc.contributor.author | Ni, Q. | |
dc.contributor.author | Zhang, P. | |
dc.contributor.author | Popat, S. | |
dc.date.accessioned | 2021-01-06T11:15:16Z | |
dc.date.available | 2021-01-06T11:15:16Z | |
dc.date.issued | 2020 | en |
dc.identifier.citation | Califano 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-S60 | en |
dc.identifier.uri | http://hdl.handle.net/10541/623584 | |
dc.description.abstract | Introduction: 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.iso | en | en |
dc.title | Brigatinib versus crizotinib in patients with ALK inhibitor-naive advanced ALK plus NSCLC: results from the phase 3 ALTA-1L trial | en |
dc.type | Meetings and Proceedings | en |
dc.contributor.department | The Christie NHS Foundation Trust, Manchester | en |
dc.identifier.journal | Lung Cancer | en |
dc.description.note | en] |