2022
Association of depth of target lesion response to brigatinib with outcomes in patients with ALK inhibitor-naive ALK+ NSCLC in ALTA-1L.
Camidge D, Kim H, Ahn M, Yang J, Han J, Hochmair M, Lee K, Delmonte A, Campelo R, Kim D, Griesinger F, Felip E, Califano R, Spira A, Thomas M, Gettinger S, Tiseo M, Liu Y, Zhang P, Popat S. Association of depth of target lesion response to brigatinib with outcomes in patients with ALK inhibitor-naive ALK+ NSCLC in ALTA-1L. Journal Of Clinical Oncology 2022, 40: 9072-9072. DOI: 10.1200/jco.2022.40.16_suppl.9072.Peer-Reviewed Original ResearchBlinded independent review committeeTarget lesion assessmentTarget lesion responseLesion shrinkageLesion responseLesion assessmentCochran-Armitage trend analysisRandomized phase 3 trialShrinkage groupPhase 3 trialDepth of responseIndependent review committeeLonger median timeMajority of ptsAssociation of depthRECIST v1.1PFS eventsMedian ageOS ratesMedian timeStudy endTarget lesionsLower riskDeep responsesBrigatinib
2021
Brigatinib Versus Crizotinib in ALK Inhibitor–Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial
Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, Garcia Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira AI, Gettinger SN, Tiseo M, Lin HM, Liu Y, Vranceanu F, Niu H, Zhang P, Popat S. Brigatinib Versus Crizotinib in ALK Inhibitor–Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial. Journal Of Thoracic Oncology 2021, 16: 2091-2108. PMID: 34537440, DOI: 10.1016/j.jtho.2021.07.035.Peer-Reviewed Original ResearchConceptsBlinded independent review committeeIndependent review committeeBrain metastasesSurvival benefitSuperior efficacyTP53 mutationsAdvanced ALK-positive NSCLCBaseline brain metastasesSecondary ALK mutationsMedian overall survivalOverall survival benefitPrimary end pointNew safety signalsPhase 3 studyALK-positive NSCLCLung cancer trialsPlasma cell-free DNAPoor prognostic biomarkerReview CommitteeEML4-ALK variantsCell-free DNAAdvanced ALKOverall survivalPoor PFSPositive NSCLC
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
2019
LBA1 Brigatinib vs crizotinib in patients with ALK inhibitor-naive advanced ALK+ NSCLC: Updated results from the phase III ALTA-1L trial
Camidge R, Kim H, Ahn M, Yang J, Han J, Hochmair M, Lee K, Delmonte A, Campelo M, Kim D, Griesinger F, Felip E, Califano R, Spira A, Gettinger S, Tiseo M, Ni Q, Zhang P, Popat S. LBA1 Brigatinib vs crizotinib in patients with ALK inhibitor-naive advanced ALK+ NSCLC: Updated results from the phase III ALTA-1L trial. Annals Of Oncology 2019, 30: ix195-ix196. DOI: 10.1093/annonc/mdz446.Peer-Reviewed Original ResearchBrain metastasesPFS eventsTakeda Pharmaceutical Company LimitedPrior chemotherapyBoehringer IngelheimInterim analysisARIAD PharmaceuticalsGuardant HealthPFS HREli LillyBlinded independent review committeeClovis OncologyAdditional efficacy dataAsymptomatic CNS metastasesBaseline brain metastasesECOG PS 0Measurable brain metastasesObjective response rateProgression-free survivalSecond interim analysisPatient-reported qualityDuration of responseIndependent review committeeRoche/GenentechBristol-Myers SquibbO1-4-2 [Encore] Brigatinib (BRG) vs Crizotinib (CRZ) in Patients (Pts) With ALK Inhibitor-Naive Advanced ALK+ NSCLC from ALTA-1L
Yang J, Kim H, Ahn M, Han J, Hochmair M, Lee K, Delmonte A, Campelo M, Kim D, Felip E, Califano R, Spira A, Gettinger S, Tiseo M, Haney J, Kerstein D, Popat S, Camidge D. O1-4-2 [Encore] Brigatinib (BRG) vs Crizotinib (CRZ) in Patients (Pts) With ALK Inhibitor-Naive Advanced ALK+ NSCLC from ALTA-1L. Annals Of Oncology 2019, 30: vi83. DOI: 10.1093/annonc/mdz339.006.Peer-Reviewed Original ResearchIntracranial ORRInterim analysisPFS eventsBlinded independent review committeeAsymptomatic CNS metastasesBaseline brain metastasesMost common gradeSecondary efficacy endpointsFirst interim analysisIndependent review committeeCNS metastasisMedian iPFSMedian PFSPrior chemotherapyAdvanced diseaseEfficacy endpointPrimary endpointBrain metastasesData cutoffSystemic therapyALK-TKIMedian ageMulticenter studyCommon gradeCrizotinib