2022
Dynamic changes in serum analyte levels associated with clinical outcome in squamous cell lung cancer trial SWOG Lung-MAP S1400I of nivolumab ± ipilimumab.
Gonzalez-Kozlova E, Huang H, Redman M, Herbst R, Gettinger S, Bazhenova L, Xie H, Patel M, Nie K, Harris J, Argueta K, Cerami E, Hong J, Biswas R, Van Nostrand S, Kelly K, Moravec R, Del Valle D, Kim-Schulze S, Gnjatic S. Dynamic changes in serum analyte levels associated with clinical outcome in squamous cell lung cancer trial SWOG Lung-MAP S1400I of nivolumab ± ipilimumab. Journal Of Clinical Oncology 2022, 40: 9044-9044. DOI: 10.1200/jco.2022.40.16_suppl.9044.Peer-Reviewed Original ResearchImmune checkpoint blockadeSerial blood specimensObjective responseOverall survivalLung cancerBlood specimensCox modelRecurrent squamous cell lung cancerWk 3Randomized phase III trialSquamous cell lung cancerPhase III trialsBest objective responseCell lung cancerRisk of deathProtein levelsSerum analyte levelsIndicators of outcomeLinear mixed modelsSerum protein levelsProximity extension assayMeasurement of bloodEligible patientsLower IL6Checkpoint blockade
2021
Clinical definition of acquired resistance to immunotherapy in patients with metastatic non-small-cell lung cancer
Schoenfeld A, Antonia S, Awad M, Felip E, Gainor J, Gettinger S, Hodi F, Johnson M, Leighl N, Lovly C, Mok T, Perol M, Reck M, Solomon B, Soria J, Tan D, Peters S, Hellmann M. Clinical definition of acquired resistance to immunotherapy in patients with metastatic non-small-cell lung cancer. Annals Of Oncology 2021, 32: 1597-1607. PMID: 34487855, DOI: 10.1016/j.annonc.2021.08.2151.Peer-Reviewed Original ResearchConceptsCell lung cancerClinical definitionAcquired ResistanceLung cancerClinical trialsCell death protein 1/Death protein 1/Consistent clinical definitionPersistent antitumor immunityProspective clinical trialsInvestigational immunotherapiesAntitumor immunityObjective responseProgressive diseaseAntibody treatmentNSCLC biologyInitial respondersTreatment strategiesClinical reportsPatientsBlockadeImmunotherapyTherapeutic discoveryCancerUniform criteria
2019
1543P 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
2017
Brigatinib (BRG) in patients (pts) with ALK+ non-small cell lung cancer (NSCLC): Updates 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 D. Brigatinib (BRG) in patients (pts) with ALK+ non-small cell lung cancer (NSCLC): Updates from a phase 1/2 trial. Journal Of Clinical Oncology 2017, 35: e20682-e20682. DOI: 10.1200/jco.2017.35.15_suppl.e20682.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalTreatment-emergent adverse eventsBaseline brain metastasesNSCLC ptsPhase 1/2 trialAdverse eventsBrain metastasesObjective responseSerious treatment-emergent adverse eventsMedian intracranial progression-free survivalIntracranial progression-free survivalRandomized phase 2 trialIntracranial objective responseMedian overall survivalMedian treatment durationPhase 2 trialCell lung cancerOral brigatinibRECIST v1.1Advanced malignanciesGrade 1/2Median durationOverall survivalMulticenter trial
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 followActivity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial
Gettinger SN, Bazhenova LA, Langer CJ, Salgia R, Gold KA, Rosell R, Shaw AT, Weiss GJ, Tugnait M, Narasimhan NI, Dorer DJ, Kerstein D, Rivera VM, Clackson T, Haluska FG, Camidge DR. Activity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial. The Lancet Oncology 2016, 17: 1683-1696. PMID: 27836716, DOI: 10.1016/s1470-2045(16)30392-8.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsPhase 2 doseCell lung cancerObjective responsePrimary endpointAdvanced malignanciesAdverse eventsLung cancerGrade 3ALK inhibitorsPrevious EGFR-tyrosine kinase inhibitorsSerious treatment-emergent adverse eventsCohort 5Phase 2 primary endpointRandomised phase 2 trialPotential new treatment optionAnaplastic lymphoma kinase (ALK) gene rearrangementEGFR tyrosine kinase inhibitorsCommon grade 3Acceptable safety profilePhase 2 trialProportion of patientsTotal daily dosesPotent preclinical activityNew treatment options
2014
Dual Inhibition of EGFR with Afatinib and Cetuximab in Kinase Inhibitor–Resistant EGFR-Mutant Lung Cancer with and without T790M Mutations
Janjigian YY, Smit EF, Groen HJ, Horn L, Gettinger S, Camidge DR, Riely GJ, Wang B, Fu Y, Chand VK, Miller VA, Pao W. Dual Inhibition of EGFR with Afatinib and Cetuximab in Kinase Inhibitor–Resistant EGFR-Mutant Lung Cancer with and without T790M Mutations. Cancer Discovery 2014, 4: 1036-1045. PMID: 25074459, PMCID: PMC4155006, DOI: 10.1158/2159-8290.cd-14-0326.Peer-Reviewed Original ResearchConceptsEGFR-mutant lung cancerT790M mutationLung cancerM mutationGrade 3/4 adverse eventsMedian progression-free survivalEGFR T790M mutationErlotinib/gefitinibRobust clinical activityT790M-negative tumorsManageable safety profileObjective response ratePhase Ib studyProgression-free survivalMutant lung cancerGefitinib/erlotinibFirst clinical proofReversible EGFR inhibitorsAdverse eventsMedian durationObjective responseSafety profilePreclinical hypothesisEGFR mutationsClinical activity1229PD 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 factorsNSCLCNivolumab
2012
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
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 toxicity1227O Activity of Afatinib/Cetuximab in Patients (PTS) with EGFR Mutant Non-Small Cell Lung Cancer (Nsclc) and Acquired Resistance (Ar) To EGFR Inhibitors
Janjigian Y, Smit E, Horn L, Groen H, Camidge D, Gettinger S, Fu Y, Denis L, Miller V, Pao W. 1227O Activity of Afatinib/Cetuximab in Patients (PTS) with EGFR Mutant Non-Small Cell Lung Cancer (Nsclc) and Acquired Resistance (Ar) To EGFR Inhibitors. Annals Of Oncology 2012, 23: ix400-ix401. DOI: 10.1016/s0923-7534(20)33838-2.Peer-Reviewed Original ResearchProgression-free survivalTyrosine kinase inhibitorsBoehringer IngelheimObjective responseClinical dataProbability of PFSMutant non-small cell lung cancerEGFR-mutant non-small cell lung cancerNon-small cell lung cancerMedian progression-free survivalEGFR T790M mutationClovis OncologyEGFR T790M testingErbB family blockerCell lung cancerEarly clinical dataCombination of afatinibEGFR-mutant NSCLCSpecific tyrosine kinase inhibitorT790M mutationUniversity Medical CenterTransgenic murine modelT790M testingEpidermal growth factor receptorEligible ptsSafety, Activity, and Immune Correlates of Anti–PD-1 Antibody in Cancer
Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, Activity, and Immune Correlates of Anti–PD-1 Antibody in Cancer. New England Journal Of Medicine 2012, 366: 2443-2454. PMID: 22658127, PMCID: PMC3544539, DOI: 10.1056/nejmoa1200690.Peer-Reviewed Original ResearchConceptsAnti-PD-1 antibodyCell lung cancerRenal cell cancerObjective responseLung cancerAdverse eventsPD-L1Drug-related adverse eventsPD-1 ligand expressionCastration-resistant prostate cancerImmune-related causesPretreatment tumor specimensAdverse event profilePD-L1 expressionPD-1-PDCumulative response rateBMS-936558Immune correlatesL1 pathwayAdvanced melanomaComplete responseDeath-1PD-1Negative tumorsPositive tumors