dc.contributor.author | Camidge, DR | |
dc.contributor.author | Kim, HR | |
dc.contributor.author | Ahn, M-J | |
dc.contributor.author | Yang, JCH | |
dc.contributor.author | Han, J-Y | |
dc.contributor.author | Hochmair, MJ | |
dc.contributor.author | Lee, KH | |
dc.contributor.author | Delmonte, A | |
dc.contributor.author | García Campelo, MR | |
dc.contributor.author | Kim, D-W | |
dc.contributor.author | Griesinger, F | |
dc.contributor.author | Felip, E | |
dc.contributor.author | Califano, R | |
dc.contributor.author | Spira, A | |
dc.contributor.author | Gettinger, SN | |
dc.contributor.author | Tiseo, M | |
dc.contributor.author | Lin, HM | |
dc.contributor.author | Gupta, N | |
dc.contributor.author | Hanley, MJ | |
dc.contributor.author | Ni, Q | |
dc.contributor.author | Zhang, P | |
dc.contributor.author | Popat, S | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2022-09-02T09:47:32Z | |
dc.date.available | 2022-09-02T09:47:32Z | |
dc.date.issued | 2020-11-01 | |
dc.identifier.citation | Journal of Clinical Oncology, 2020, 38 (31), pp. 3592 - 3603 | en_US |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5380 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/JCO.20.00505 | |
dc.description.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. | |
dc.format | Print-Electronic | |
dc.format.extent | 3592 - 3603 | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | AMER SOC CLINICAL ONCOLOGY | en_US |
dc.relation.ispartof | Journal of Clinical Oncology | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | en_US |
dc.subject | Adolescent | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Anaplastic Lymphoma Kinase | |
dc.subject | Antineoplastic Agents | |
dc.subject | Carcinoma, Non-Small-Cell Lung | |
dc.subject | Crizotinib | |
dc.subject | Female | |
dc.subject | Humans | |
dc.subject | Lung Neoplasms | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Organophosphorus Compounds | |
dc.subject | Progression-Free Survival | |
dc.subject | Pyrimidines | |
dc.subject | Quality of Life | |
dc.subject | Survival Rate | |
dc.subject | Young Adult | |
dc.title | 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. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2020-08-11 | |
dc.date.updated | 2022-09-02T09:46:32Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1200/JCO.20.00505 | en_US |
rioxxterms.licenseref.startdate | 2020-11-01 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/32780660 | |
pubs.issue | 31 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Thoracic Oncology | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Thoracic Oncology/Thoracic Oncology (hon.) | |
pubs.publication-status | Published | |
pubs.publisher-url | http://dx.doi.org/10.1200/jco.20.00505 | |
pubs.volume | 38 | |
dc.contributor.icrauthor | Popat, Sanjay | |
icr.provenance | Deposited by Mr Arek Surman on 2022-09-02. Deposit type is initial. No. of files: 1. Files: Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer Second Interim Analysis.pdf | |