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 Squibb1543P 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 ageFour-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis
Antonia SJ, Borghaei H, Ramalingam SS, Horn L, De Castro Carpeño J, Pluzanski A, Burgio MA, Garassino M, Chow LQM, Gettinger S, Crinò L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson GA, Agrawal S, Li A, Penrod JR, Brahmer J. Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis. The Lancet Oncology 2019, 20: 1395-1408. PMID: 31422028, PMCID: PMC7193685, DOI: 10.1016/s1470-2045(19)30407-3.Peer-Reviewed Original ResearchConceptsPD-L1 expressionCell lung cancerOverall survivalCheckMate 017Progressive diseaseHazard ratioSurvival outcomesLung cancerLong-term survival advantageDose of nivolumabTrials of nivolumabNew safety signalsFour-year survivalLonger overall survivalLonger response durationBristol-Myers SquibbStable diseaseAdvanced NSCLCObjective responsePooled analysisLong-term benefitsNivolumabSafety signalsClinical dataClinical studies
2016
Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study
Hellmann MD, Rizvi NA, Goldman JW, Gettinger SN, Borghaei H, Brahmer JR, Ready NE, Gerber DE, Chow LQ, Juergens RA, Shepherd FA, Laurie SA, Geese WJ, Agrawal S, Young TC, Li X, Antonia SJ. Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study. The Lancet Oncology 2016, 18: 31-41. PMID: 27932067, PMCID: PMC5476941, DOI: 10.1016/s1470-2045(16)30624-6.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCell lung cancerAdverse eventsObjective responseLung cancerGrade 3Treatment-related serious adverse eventsAnti-PD-1 monotherapyChemotherapy-naive NSCLCTolerable safety profileTreatment-related deathsSerious adverse eventsFirst-line therapyFirst-line treatmentPhase 3 studyUS academic centersFirst-line nivolumabWithdrawal of consentFurther clinical developmentHigh response ratePhase 1Bristol-Myers SquibbCombination nivolumabEligible patientsMedian follow
2014
1229PD Smoking History and Response to Nivolumab in Patients with Advanced Nsclcs
Hellmann M, Creelan B, Woo K, Sima C, Iams W, Antonia S, Horn L, Brahmer J, Gettinger S, Harbison C, Rizvi N. 1229PD Smoking History and Response to Nivolumab in Patients with Advanced Nsclcs. Annals Of Oncology 2014, 25: iv429. DOI: 10.1093/annonc/mdu349.8.Peer-Reviewed Original ResearchBristol-Myers SquibbCurrent smokersSmoking historyAdvanced NSCLCResponse rateMutation burdenPD-1 pathway inhibitorsSelf-reported smoking historySubset of ptsHigh somatic mutation burdenLog-rank testSomatic mutation burdenKRAS MUTRECIST v1.0Squamous histologyObjective responseSmoking statusTobacco exposureKRAS genotypeLung cancerMutational burdenSmokersStratification factorsNSCLCNivolumab1322P Biomarkers Associated with Clinical Activity of Pd-L1 Blockade in Non-Small Cell Lung Cancer (Nsclc) Patients (Pts) in a Phase I Study of Mpdl3280A
Soria J, Gettinger S, Gordon M, Heist R, Horn L, Spigel D, Kowanetz M, Mokatrin A, Xiao Y, Sandler A, Felip E. 1322P Biomarkers Associated with Clinical Activity of Pd-L1 Blockade in Non-Small Cell Lung Cancer (Nsclc) Patients (Pts) in a Phase I Study of Mpdl3280A. Annals Of Oncology 2014, 25: iv465. DOI: 10.1093/annonc/mdu349.101.Peer-Reviewed Original ResearchPD-L1 expressionPD-L1 blockadeIHC 2PD-L1Immune cellsNSCLC ptsB7-H4B7-H3PD-L2Tumor cellsIHC 0Clinical activityNon-small cell lung cancer patientsTumor-infiltrating immune cellsCell lung cancer patientsEmployees of GenentechReceptor PD-1Tumor immune microenvironmentLung cancer patientsPD-L1 IHCPD-L1 bindingRoche/GenentechImmune-related genesBristol-Myers SquibbPFS rates
2012
1237PD Clinical Activity and Safety of Anti-Programmed Death-1 (PD-1) (BMS-936558/MDX-1106/ONO-4538) in Patients (PTS) with Advanced Non-Small Cell Lung Cancer (NSCLC)
Gettinger S, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Wigginton J, Kollia G, Gupta A, Brahmer J. 1237PD Clinical Activity and Safety of Anti-Programmed Death-1 (PD-1) (BMS-936558/MDX-1106/ONO-4538) in Patients (PTS) with Advanced Non-Small Cell Lung Cancer (NSCLC). Annals Of Oncology 2012, 23: ix405. DOI: 10.1016/s0923-7534(20)33809-6.Peer-Reviewed Original ResearchAdvanced non-small cell lung cancerNon-small cell lung cancerBristol-Myers SquibbBMS-936558NSCLC ptsStable diseasePartial responseClinical activitySquamous non-small cell lung cancerAdditional long-term followCommon drug-related AEsDrug-related AEsECOG performance statusObjective response rateCo-inhibitory receptorsLong-term followCell lung cancerCycles of treatmentDrug-related deathsHuman monoclonal antibodyActivated T cellsCohort expansionEvaluable ptsPrior therapyRECIST v1.0453P Anti-Programmed Death-1 (PD-1) (BMS-936558/MDX-1106/ONO-4538) in Patients (PTS) with Advanced Solid Tumors: Clinical Activity, Safety, and Molecular Markers
Topalian S, Brahmer J, Hodi F, McDermott D, Smith D, Gettinger S, Taube J, Gupta A, Wigginton J, Sznol M. 453P Anti-Programmed Death-1 (PD-1) (BMS-936558/MDX-1106/ONO-4538) in Patients (PTS) with Advanced Solid Tumors: Clinical Activity, Safety, and Molecular Markers. Annals Of Oncology 2012, 23: ix157. DOI: 10.1016/s0923-7534(20)33011-8.Peer-Reviewed Original ResearchBristol-Myers SquibbBMS-936558Objective responseAnti-PD-1 monoclonal antibodyAdditional long-term followAnti-programmed death-1PD-L1 expression statusProgression-free survival ratesNon-small cell lungDrug-related AEsObjective response rateAdvanced solid tumorsCo-inhibitory receptorsPretreatment tumor biopsiesPD-1 ligandsLong-term followOverall tumor burdenFurther clinical developmentPredictive molecular markersActivated T cellsCohort expansionRECIST v1.0Stable diseaseAdvanced NSCLCUnacceptable toxicity1267P A Large Retrospective Analysis of Pemetrexed (PEM) Activity in Patients (PTS) with Alk-Positive (Alk+) Non-Small Cell Lung Cancer (NSCLC) Prior to Crizotinib (CRIZ) Treatment
Scagliotti G, Kim D, Shaw A, Ou S, Riely G, Gettinger S, Besse B, Wilner K, Tang Y, Bartlett C. 1267P A Large Retrospective Analysis of Pemetrexed (PEM) Activity in Patients (PTS) with Alk-Positive (Alk+) Non-Small Cell Lung Cancer (NSCLC) Prior to Crizotinib (CRIZ) Treatment. Annals Of Oncology 2012, 23: ix415. DOI: 10.1016/s0923-7534(20)33862-x.Peer-Reviewed Original ResearchNon-small cell lung cancerHigher overall response rateOverall response rateMedian TTPRetrospective analysisALK-positive non-small cell lung cancerBest overall response rateYounger ageLower overall response rateSmall retrospective cohortLarge retrospective analysisSingle-arm studyCell lung cancerSmall cohort studiesLarge phase 2Similar demographic characteristicsBristol-Myers SquibbAdenocarcinoma histologyBetter PFSCrizotinib treatmentPemetrexed activityClinical characteristicsCohort studyFormer smokersRetrospective cohort