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Cited by 351

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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

Open access
Camidge, D. Ross, Kim, Hye Ryun, Ahn, Myung-Ju, Yang, James C. H., Han, Ji-Youn, Hochmair, Maximilian J., Lee, Ki Hyeong, Delmonte, Angelo, García 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·2020·Journal of Clinical Oncology

Abstract

PURPOSE: Brigatinib, 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). METHODS: Patients 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. RESULTS: Two 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). CONCLUSION: Brigatinib 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.

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Metadata

Authors
Camidge, D. R., Kim, H. R., Ahn, M.-J., Yang, J. C. H., Han, J.-Y., Hochmair, M. J., Lee, K. H., Delmonte, A., García Campelo, M. R., Kim, D.-W., Griesinger, F., Felip, E., Califano, R., Spira, A., Gettinger, S. N., Tiseo, M., Lin, H. M., Gupta, N., Hanley, M. J., Ni, Q., Zhang, P., & Popat, S.
Venue
Journal of Clinical Oncology
Published
2020-11-01
Volume
38
Issue
31
Pages
3592-3603
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W3048441995
Cited by
351
References
6
FWCI
32.38
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: 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. https://app.cochat.ai/papers/10.1200/jco.20.00505
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Camidge, D. R., Kim, H. R., Ahn, M.-J., Yang, J. C. H., Han, J.-Y., Hochmair, M. J., Lee, K. H., Delmonte, A., García Campelo, M. R., Kim, D.-W., Griesinger, F., Felip, E., Califano, R., Spira, A., Gettinger, S. N., Tiseo, M., Lin, H. M., Gupta, N., Hanley, M. J., . . . Popat, S. (2020). 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. Journal of Clinical Oncology. https://doi.org/10.1200/jco.20.00505

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.