2019
Brigatinib in Crizotinib-Refractory ALK+ NSCLC: 2-Year Follow-up on Systemic and Intracranial Outcomes in the Phase 2 ALTA Trial
Huber RM, Hansen KH, Paz-Ares Rodríguez L, West HL, Reckamp KL, Leighl NB, Tiseo M, Smit EF, Kim DW, Gettinger SN, Hochmair MJ, Kim SW, Langer CJ, Ahn MJ, Kim ES, Kerstein D, Groen HJM, Camidge DR. Brigatinib in Crizotinib-Refractory ALK+ NSCLC: 2-Year Follow-up on Systemic and Intracranial Outcomes in the Phase 2 ALTA Trial. Journal Of Thoracic Oncology 2019, 15: 404-415. PMID: 31756496, DOI: 10.1016/j.jtho.2019.11.004.Peer-Reviewed Original ResearchConceptsProgression-free survivalObjective response rateIntracranial objective response rateOverall survivalIntracranial PFSResponse rateEnd pointIntracranial responseBrain lesionsCentral nervous system metastasesSolid Tumors version 1.1Intracranial progression-free survivalCrizotinib-refractory patientsMedian overall survivalNervous system metastasesNew safety findingsPrimary end pointSecondary end pointsTarget lesion responseResponse Evaluation CriteriaIndependent review committeeDepth of responseImportant end pointIntracranial outcomesOral brigatinib
2017
Brigatinib (BRG) in crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): Updates from ALTA, a pivotal randomized phase 2 trial.
Ahn M, Camidge D, Tiseo M, Reckamp K, Holmskov Hansen K, Kim S, Huber R, West H, Groen H, Hochmair M, Leighl N, Gettinger S, Langer C, Paz-Ares L, Smit E, Kim E, Reichmann W, Kerstein D, Kim D. Brigatinib (BRG) in crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): Updates from ALTA, a pivotal randomized phase 2 trial. Journal Of Clinical Oncology 2017, 35: e20503-e20503. DOI: 10.1200/jco.2017.35.15_suppl.e20503.Peer-Reviewed Original ResearchNon-small cell lung cancerObjective response rateRandomized phase 2 trialPhase 2 trialAdverse eventsBrain metastasesMost common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsTreatment-emergent adverse eventsIntracranial objective response rateBaseline brain metastasesPulmonary adverse eventsPhase 1/2 trialCell lung cancerRECIST v1.1Primary endpointNSCLC patientsMedian ageAcceptable safetyLung cancerDisease progressionDose reductionDose levelsResponse rateBrigatinibBrigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase–Positive Non–Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial
Kim DW, Tiseo M, Ahn MJ, Reckamp KL, Hansen KH, Kim SW, Huber RM, West HL, Groen HJM, Hochmair MJ, Leighl NB, Gettinger SN, Langer CJ, Paz-Ares Rodríguez LG, Smit EF, Kim ES, Reichmann W, Haluska FG, Kerstein D, Camidge DR. Brigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase–Positive Non–Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial. Journal Of Clinical Oncology 2017, 35: jco.2016.71.590. PMID: 28475456, DOI: 10.1200/jco.2016.71.5904.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAnaplastic Lymphoma KinaseAntineoplastic AgentsBrain NeoplasmsCarcinoma, Non-Small-Cell LungCoughCrizotinibDiarrheaDisease ProgressionDisease-Free SurvivalFemaleHeadacheHumansLung NeoplasmsMaleMiddle AgedNauseaOrganophosphorus CompoundsProspective StudiesPyrazolesPyridinesPyrimidinesReceptor Protein-Tyrosine KinasesRetreatmentTreatment OutcomeYoung AdultConceptsObjective response rateProgression-free survivalBrain metastasesArm AAdverse eventsLung cancerInvestigator-assessed median progression-free survivalCommon treatment-emergent adverse eventsPositive non-small cell lung cancerNon-small cell lung cancerMedian progression-free survivalMulticenter phase II trialNext-generation ALK inhibitorsTreatment-emergent adverse eventsIntracranial objective response rateBaseline brain metastasesCrizotinib-treated patientsMeasurable brain metastasesPulmonary adverse eventsPrimary end pointPhase II trialCell lung cancerALK-positive NSCLCAnaplastic lymphoma kinase (ALK) geneAnaplastic lymphoma kinase