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Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial

Cited 213 time in Web of Science Cited 242 time in Scopus
Authors

Camidge, D. Ross; Kim, Hye Ryun; Ahn, Myung-Ju; Yang, James C. H.; Han, Ji-Youn; Hochmair, Maximilian J.; Lee, Ki Hyeong; Delmonte, Angelo; Garcia Campelo, Maria Rosario; Kim, Dong-Wan; Griesinger, Frank; Felip, Enriqueta; Califano, Raffaele; Spira, Alexander; Gettinger, Scott N.; Tiseo, Marcello; Lin, Huamao M.; Gupta, Neeraj; Hanley, Michael J.; Ni, Quanhong; Zhang, Pingkuan; Popat, Sanjay

Issue Date
2020-11-01
Publisher
American Society of Clinical Oncology
Citation
Journal of Clinical Oncology, Vol.38 No.31, pp.3592-3603
Abstract
PURPOSEBrigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus crizotinib in advanced ALK inhibitor-naive ALK-positive non-small cell lung cancer (NSCLC) at first interim analysis (99 events; median brigatinib follow-up, 11.0 months) in the open-label, phase III ALTA-1L trial (ClinicalTrials.gov identifier: NCT02737501). We report results of the second prespecified interim analysis (150 events).METHODSPatients with ALK inhibitor-naive advanced ALK-positive NSCLC were randomly assigned 1:1 to brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily. The primary end point was PFS as assessed by blinded independent review committee (BIRC). Investigator-assessed efficacy, blood samples for pharmacokinetic assessments, and patient-reported outcomes were also collected.RESULTSTwo hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138). With median follow-up of 24.9 months for brigatinib (150 PFS events), brigatinib showed consistent superiority in BIRC-assessed PFS versus crizotinib (hazard ratio [HR], 0.49 [95% CI, 0.35 to 0.68]; log-rank P < .0001; median, 24.0 v 11.0 months). Investigator-assessed PFS HR was 0.43 (95% CI, 0.31 to 0.61; median, 29.4 v 9.2 months). No new safety concerns emerged. Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank P = .049). Brigatinib daily area under the plasma concentration-time curve was not a predictor of PFS (HR, 1.005 [95% CI, 0.98 to 1.031]; P = .69).CONCLUSIONBrigatinib represents a once-daily ALK inhibitor with superior efficacy, tolerability, and QoL over crizotinib, making it a promising first-line treatment of ALK-positive NSCLC.
ISSN
0732-183X
URI
https://hdl.handle.net/10371/171809
DOI
https://doi.org/10.1200/JCO.20.00505
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