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
2020
First-Line Therapy Using Brigatinib vs. Crizotinib in Patients With Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: Results From a Phase 3 Trial
Hochmair M, Camidge, Kim H, Ahn M, Yang J, Han J, Lee K, Delmonte A, Campelo G, Kim D, Griesinger F, Felip E, Califano R, Spira A, Gettinger S, Tiseo M, Ni Q, Zhang P, Popat S. First-Line Therapy Using Brigatinib vs. Crizotinib in Patients With Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: Results From a Phase 3 Trial. Pneumologie 2020, 74: 131-131. DOI: 10.1055/s-0039-3403360.Peer-Reviewed Original Research
2018
PL02.03 Brigatinib vs Crizotinib in Patients With ALK Inhibitor-Naive Advanced ALK+ NSCLC: First Report of a Phase 3 Trial (ALTA-1L)
Camidge R, Kim H, Ahn M, Yang J, Han J, Lee J, Hochmair M, Li J, Chang G, Lee K, Gridelli C, Delmonte A, Campelo M, Kim D, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger S, Tiseo M, Haney J, Kerstein D, Popat S. PL02.03 Brigatinib vs Crizotinib in Patients With ALK Inhibitor-Naive Advanced ALK+ NSCLC: First Report of a Phase 3 Trial (ALTA-1L). Journal Of Thoracic Oncology 2018, 13: s184-s185. DOI: 10.1016/j.jtho.2018.08.011.Peer-Reviewed Original ResearchBrigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer
Camidge DR, Kim HR, Ahn MJ, Yang JC, Han JY, Lee JS, Hochmair MJ, Li JY, Chang GC, Lee KH, Gridelli C, Delmonte A, Garcia Campelo R, Kim DW, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger SN, Tiseo M, Gupta N, Haney J, Kerstein D, Popat S. Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer. New England Journal Of Medicine 2018, 379: 2027-2039. PMID: 30280657, DOI: 10.1056/nejmoa1810171.Peer-Reviewed Original ResearchConceptsProgression-free survivalALK-positive NSCLCAdvanced ALK-positive NSCLCObjective response rateFirst interim analysisALK inhibitorsLung cancerIntracranial responseInterim analysisNext-generation anaplastic lymphoma kinase (ALK) inhibitorResponse rateConfirmed objective response rateEnd pointSmall cell lung cancerBlinded independent central reviewAnaplastic lymphoma kinase inhibitorsEfficacy of brigatinibPrimary end pointSecondary end pointsPhase 3 trialALK-Positive NonCell lung cancerIndependent central reviewNew safety concernsCrizotinib group
2017
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).
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 pts
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 Research
2012
IS7-15 A Large Retrospective Analysis of the Activity of Pemetrexed (PEM) in Patients (Patients) with ALK+ NSCLC Before Crizotinib (CRIZ)
Scagliotti G, Kim D, Shaw A, Ou S, Riely G, Gettinger S, Besse B, Thomas M, Salgia R, Wilner K, Bartlett C, Polli A, Gandara D. IS7-15 A Large Retrospective Analysis of the Activity of Pemetrexed (PEM) in Patients (Patients) with ALK+ NSCLC Before Crizotinib (CRIZ). Annals Of Oncology 2012, 23: xi33. DOI: 10.1016/s0923-7534(20)32007-x.Peer-Reviewed Original ResearchObjective response rateMedian TTPPROFILE 1007Response rateLow objective response rateOngoing phase 3 trialsHigher objective response ratePhase 3 trialLarge retrospective analysisSingle-arm studySmall cohort studiesLarge phase 2High response rateAdenocarcinoma NSCLCBetter PFSCrossover patientsMedian PFSProgressive diseaseCohort studyNSCLC cohortRetrospective studyShorter TTPALK statusRetrospective analysisPemetrexedA large retrospective analysis of the activity of pemetrexed (PEM) in patients (pts) with ALK -positive ( ALK +) non-small cell lung cancer (NSCLC) prior to crizotinib (CRIZ).
Scagliotti G, Kim D, Shaw A, Ou S, Riely G, Gettinger S, Besse B, Thomas M, Salgia R, Wilner K, Bartlett C, Polli A, Gandara D. A large retrospective analysis of the activity of pemetrexed (PEM) in patients (pts) with ALK -positive ( ALK +) non-small cell lung cancer (NSCLC) prior to crizotinib (CRIZ). Journal Of Clinical Oncology 2012, 30: 7599-7599. DOI: 10.1200/jco.2012.30.15_suppl.7599.Peer-Reviewed Original ResearchNon-small cell lung cancerObjective response ratePROFILE 1007Median TTPAdenocarcinoma non-small cell lung cancerALK-positive non-small cell lung cancerResponse rateLow objective response rateOngoing phase 3 trialsHigher objective response ratePhase 3 trialSingle-arm studyLarge retrospective analysisCell lung cancerSmall cohort studiesLarge phase 2High response rateBetter PFSMedian PFSNSCLC cohortProgressive diseaseCohort studyRetrospective studyShorter TTPALK status