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
Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, Campelo M, Kim DW, Griesinger F, Felip E, Califano R, Spira A, Gettinger SN, Tiseo M, Lin HM, Gupta N, Hanley MJ, Ni Q, Zhang P, Popat S. 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 2020, 38: 3592-3603. PMID: 32780660, PMCID: PMC7605398, DOI: 10.1200/jco.20.00505.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerALK-positive non-small cell lung cancerProgression-free survivalBlinded independent review committeeCell lung cancerInterim analysisLung cancerAdvanced ALK-positive non-small cell lung cancerGlobal health status/QoL scoreNext-generation anaplastic lymphoma kinase (ALK) inhibitorPositive non-small cell lung cancerPredictors of PFSPromising first-line treatmentSecond prespecified interim analysisSuperior progression-free survivalPlasma concentration-time curveAnaplastic lymphoma kinase inhibitorsPrespecified interim analysisPrimary end pointSecond interim analysisFirst-line treatmentFirst interim analysisHealth-related qualityIndependent review committeePatient-reported outcomes
2017
1344P Brigatinib (BRG) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC): Long-term efficacy and safety results from a phase 1/2 trial
Bazhenova L, Gettinger S, Langer C, Salgia R, Gold K, Rosell R, Shaw A, Weiss G, Haney J, Rivera V, Kerstein D, Camidge R. 1344P Brigatinib (BRG) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC): Long-term efficacy and safety results from a phase 1/2 trial. Annals Of Oncology 2017, 28: v479-v480. DOI: 10.1093/annonc/mdx380.046.Peer-Reviewed Original Research1345P Intracranial efficacy of brigatinib (BRG) in patients (Pts) With crizotinib (CRZ)-refractory anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) and baseline CNS metastases
Ou S, Tiseo M, Camidge R, Ahn M, Huber R, Hochmair M, Kim S, West H, Reckamp K, Molina J, Liu G, Delmonte A, Viteri S, Bearz A, Summers Y, Reichmann W, Kerstein D, Gettinger S, Kim D. 1345P Intracranial efficacy of brigatinib (BRG) in patients (Pts) With crizotinib (CRZ)-refractory anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) and baseline CNS metastases. Annals Of Oncology 2017, 28: v480-v481. DOI: 10.1093/annonc/mdx380.047.Peer-Reviewed Original ResearchDesign of ALTA-1L (ALK in lung cancer trial of brigatinib in first-line), a randomized phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)-naive patients (pts) with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Tiseo M, Popat S, Gettinger S, Peters S, Haney J, Kerstein D, Camidge D. Design of ALTA-1L (ALK in lung cancer trial of brigatinib in first-line), a randomized phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)-naive patients (pts) with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2017, 35: tps9098-tps9098. DOI: 10.1200/jco.2017.35.15_suppl.tps9098.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalObjective response rateRandomized phase 3 trialPhase 3 trialPrimary endpointTKI therapyPositive non-small cell lung cancerAdvanced anaplastic lymphoma kinaseNext-generation ALK inhibitorsRandomized phase 2 trialPrior TKI therapySafety/tolerabilityPhase 1/2 trialPhase 2 trialKaplan-Meier methodCell lung cancerDuration of responseIndependent review committeeLog-rank testPotent preclinical activityTyrosine kinase inhibitorsAnaplastic lymphoma kinaseNaive patientsNSCLC ptsBrigatinib 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
2016
1289TiP ALTA-1L (ALK in lung cancer trial of BrigAtinib in 1st Line): A randomized, phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)–naive, advanced anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC)
Popat S, Tiseo M, Gettinger S, Peters S, Haney J, Kerstein D, Camidge D. 1289TiP ALTA-1L (ALK in lung cancer trial of BrigAtinib in 1st Line): A randomized, phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)–naive, advanced anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC). Annals Of Oncology 2016, 27: vi448. DOI: 10.1093/annonc/mdw383.89.Peer-Reviewed Original Research1207PD Brigatinib (BRG) in patients (Pts) with anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) in a phase 1/2 trial
Bazhenova L, Gettinger S, Langer C, Salgia R, Gold K, Rosell R, Shaw A, Weiss G, Haney J, Rivera V, Haluska F, Kerstein D, Camidge D. 1207PD Brigatinib (BRG) in patients (Pts) with anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) in a phase 1/2 trial. Annals Of Oncology 2016, 27: vi418. DOI: 10.1093/annonc/mdw383.08.Peer-Reviewed Original ResearchNon-small cell lung cancerPositive non-small cell lung cancerPhase 1/2 trialCell lung cancerAnaplastic lymphoma kinaseLung cancerLymphoma kinaseBrigatinibPatientsCancerTrials1330 Brigatinib efficacy and safety in patients (Pts) with anaplastic lymphoma kinase (ALK)-positive (ALK+) non-small cell lung cancer (NSCLC) in a phase 1/2 trial
Rosell R, Gettinger S, Bazhenova L, Langer C, Salgia R, Shaw A, Narasimhan N, Dorer D, Kerstein D, Camidge D. 1330 Brigatinib efficacy and safety in patients (Pts) with anaplastic lymphoma kinase (ALK)-positive (ALK+) non-small cell lung cancer (NSCLC) in a phase 1/2 trial. Journal Of Thoracic Oncology 2016, 11: s114. DOI: 10.1016/s1556-0864(16)30245-3.Peer-Reviewed Original ResearchNon-small cell lung cancerPositive non-small cell lung cancerPhase 1/2 trialCell lung cancerAnaplastic lymphoma kinaseLung cancerLymphoma kinasePatientsCancerTrials
2015
99O Phase 1/2 Study of Ap26113 in Patients (PTS) with Advanced Malignancies, Including Anaplastic Lymphoma Kinase (ALK)–Positive Non-Small Cell Lung Cancer (NSCLC): Analysis of Safety and Efficacy at Selected Phase 2 Doses
Rosell R, Gettinger S, Bazhenova L, Langer C, Salgia R, Gold K, Shaw A, Dorer D, Kerstein D, Camidge D. 99O Phase 1/2 Study of Ap26113 in Patients (PTS) with Advanced Malignancies, Including Anaplastic Lymphoma Kinase (ALK)–Positive Non-Small Cell Lung Cancer (NSCLC): Analysis of Safety and Efficacy at Selected Phase 2 Doses. Annals Of Oncology 2015, 26: i29. DOI: 10.1093/annonc/mdv050.03.Peer-Reviewed Original Research