2019
O1-4-2 [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 gradeCrizotinib1543P Brigatinib (BRG) in Asian vs non-Asian patients (pts) with crizotinib (CRZ)-refractory ALK+ NSCLC in the phase II ALTA trial
Lee D, Kim D, Camidge D, Langer C, Huber R, Tiseo M, West H, Groen H, Reckamp K, Hochmair M, Leighl N, Hansen K, Gettinger S, Paz-Ares L, Kim E, Smit E, Kim S, Ni Q, Zhang P, Ahn M. 1543P Brigatinib (BRG) in Asian vs non-Asian patients (pts) with crizotinib (CRZ)-refractory ALK+ NSCLC in the phase II ALTA trial. Annals Of Oncology 2019, 30: v634-v635. DOI: 10.1093/annonc/mdz260.065.Peer-Reviewed Original ResearchBristol-Myers SquibbCNS metastasesTakeda Pharmaceutical Company LimitedBoehringer IngelheimARIAD PharmaceuticalsClovis OncologyRoche/GenentechEli LillyMerck SharpBaseline CNS metastasesIntracranial objective responseMost common gradeObjective response rateProgression-free survivalDuration of responseIndependent review committeeNon-Asian patientsPierre FabreMedian DoRMedian iPFSMedian PFSRECIST v1.1Objective responseOverall survivalMedian ageProspective phase I multi-institutional trial of PD-1 blockade with pembrolizumab during concurrent chemoradiation for locally advanced, unresectable non-small cell lung cancer.
Jabbour S, Berman A, Decker R, Lin Y, Feigenberg S, Gettinger S, Aggarwal C, Langer C, Simone C, Bradley J, Aisner J, Malhotra J. Prospective phase I multi-institutional trial of PD-1 blockade with pembrolizumab during concurrent chemoradiation for locally advanced, unresectable non-small cell lung cancer. Journal Of Clinical Oncology 2019, 37: 8511-8511. DOI: 10.1200/jco.2019.37.15_suppl.8511.Peer-Reviewed Original ResearchImmune-related adverse eventsStage III NSCLCDose limiting toxicitiesChemoradiation therapyPD-1iDay 29Unresectable non-small cell lung cancerDay 1Prospective phase I clinical trialNon-small cell lung cancerDeath ligand 1 (PD-L1) inhibitionPhase I clinical trialDefinitive chemoradiation therapyGrade 3 hyperglycemiaPD-1 blockadeFurther prospective studiesCell lung cancerMulti-institutional trialDose cohortsMedian PFSQ3 weeksConcurrent chemoradiationDefinitive RTAdverse eventsInterstitial nephritis
2017
Continued use of afatinib with the addition of cetuximab after progression on afatinib in patients with EGFR mutation-positive non-small-cell lung cancer and acquired resistance to gefitinib or erlotinib
Horn L, Gettinger S, Camidge DR, Smit EF, Janjigian YY, Miller VA, Pao W, Freiwald M, Fan J, Wang B, Chand VK, Groen HJM. Continued use of afatinib with the addition of cetuximab after progression on afatinib in patients with EGFR mutation-positive non-small-cell lung cancer and acquired resistance to gefitinib or erlotinib. Lung Cancer 2017, 113: 51-58. PMID: 29110849, DOI: 10.1016/j.lungcan.2017.08.014.Peer-Reviewed Original ResearchMeSH KeywordsAdultAfatinibAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCetuximabCohort StudiesDiarrheaDisease ProgressionDrug Resistance, NeoplasmErbB ReceptorsErlotinib HydrochlorideExanthemaFemaleGefitinibHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMutationQuinazolinesConceptsEGFR mutation-positive NSCLCEpidermal growth factor receptorMutation-positive NSCLCCell lung cancerAdverse eventsAfatinib monotherapyMedian PFSLung cancerDrug-related grade 3/4 adverse eventsFrequent drug-related adverse eventsDrug-related adverse eventsGrade 3/4 adverse eventsAddition of cetuximabIntolerable adverse eventsPhase Ib trialT790M-negative tumorsPercent of patientsPredictable safety profileAfatinib dailyGrowth factor receptorIb trialSafety profileClinical activityDry skinSeparate cohortAtezolizumab (atezo) plus platinum-based chemotherapy (chemo) in non-small cell lung cancer (NSCLC): Update from a phase Ib study.
Liu S, Camidge D, Gettinger S, Giaccone G, Heist R, Hodi F, Ready N, Zhang W, Wallin J, Funke R, Waterkamp D, Foster P, Iizuka K, Powderly J. Atezolizumab (atezo) plus platinum-based chemotherapy (chemo) in non-small cell lung cancer (NSCLC): Update from a phase Ib study. Journal Of Clinical Oncology 2017, 35: 9092-9092. DOI: 10.1200/jco.2017.35.15_suppl.9092.Peer-Reviewed Original ResearchNon-small cell lung cancerOverall response rateAdverse eventsAnti-programmed death ligand 1 antibodyAdvanced non-small cell lung cancerMetastatic non-small cell lung cancerCommon treatment-related grade 3Terms of ORRConfirmed overall response rateGrade 5 adverse eventsStandard first-line therapyTreatment-related grade 3Death ligand 1 antibodyPhase Ib studyTumor antigen releaseFirst-line therapyPhase III studyPlatinum-based chemotherapyCell lung cancerActionable gene alterationsMulti-arm studiesMultiple tumor typesMedian PFSNSCLC ptsPrior chemo
2013
Subgroup analysis of crizotinib versus either pemetrexed (PEM) or docetaxel (DOC) in the phase III study (PROFILE 1007) of advanced ALK -positive non-small cell lung cancer (NSCLC).
Solomon B, Gettinger S, Riely G, Gadgeel S, Nokihara H, Han J, Hida T, Satouchi M, Baldini E, Siena S, Yamamoto N, Horn L, Tassell V, Polli A, Camidge D. Subgroup analysis of crizotinib versus either pemetrexed (PEM) or docetaxel (DOC) in the phase III study (PROFILE 1007) of advanced ALK -positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: 8105-8105. DOI: 10.1200/jco.2013.31.15_suppl.8105.Peer-Reviewed Original ResearchNon-small cell lung cancerMedian PFSPFS ratesSubgroup analysisSuperior efficacyAdvanced ALK-positive non-small cell lung cancerALK-positive non-small cell lung cancerManageable side-effect profilePrior platinum-based regimenStage IIIB/IVCausality adverse eventsMedian treatment durationPlatinum-based regimenSafety of crizotinibIIIB/IVPhase III studySide effect profileCell lung cancerIndependent radiologic reviewPEM patientsPo bidPROFILE 1007Crizotinib treatmentCare chemotherapyData cutoff
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 statusResults of a global phase II study with crizotinib in advanced ALK -positive non-small cell lung cancer (NSCLC).
Kim D, Ahn M, Shi Y, De Pas T, Yang P, Riely G, Crinò L, Evans T, Liu X, Han J, Salgia R, Moro-Sibilot D, Ou S, Gettinger S, Wu Y, Lanzalone S, Polli A, Iyer S, Shaw A. Results of a global phase II study with crizotinib in advanced ALK -positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2012, 30: 7533-7533. DOI: 10.1200/jco.2012.30.15_suppl.7533.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced ALK-positive non-small cell lung cancerALK-positive non-small cell lung cancerPatient-reported symptomsTumor responseFrequent treatment-related AEsECOG PS 0Efficacy of crizotinibPrior chemotherapy regimensTreatment-related AEsTreatment-related SAEsDisease control rateMedian treatment durationPhase II studyFavorable tolerability profileMajority of patientsCell lung cancerEnd of treatmentEORTC QLQ-C30Standard of careALK gene rearrangementHigh response rateFebrile neutropeniaLC-13Median PFS