2018
Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC
Gettinger S, Hellmann MD, Chow LQM, Borghaei H, Antonia S, Brahmer JR, Goldman JW, Gerber DE, Juergens RA, Shepherd FA, Laurie SA, Young TC, Li X, Geese WJ, Rizvi N. Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC. Journal Of Thoracic Oncology 2018, 13: 1363-1372. PMID: 29802888, DOI: 10.1016/j.jtho.2018.05.015.Peer-Reviewed Original ResearchConceptsAdvanced EGFR-mutant NSCLCEGFR-mutant NSCLCTreatment-related grade 3 toxicitiesEGFR-mutant advanced NSCLCProgression-free survival ratesEGFR T790M mutationEGFR tyrosine kinase inhibitorsGrade 3 toxicityObjective response rateTKI-naive patientsCompound EGFR mutationsT790M mutationTyrosine kinase inhibitorsImmune-related responsesInvestigator recordsAdvanced NSCLCDurable responsesUnacceptable toxicityComplete responseFourth patientDisease progressionEGFR mutationsMutant NSCLCTumor biopsiesNivolumab
2016
Nivolumab Monotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer
Gettinger S, Rizvi NA, Chow LQ, Borghaei H, Brahmer J, Ready N, Gerber DE, Shepherd FA, Antonia S, Goldman JW, Juergens RA, Laurie SA, Nathan FE, Shen Y, Harbison CT, Hellmann MD. Nivolumab Monotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2016, 34: 2980-2987. PMID: 27354485, PMCID: PMC5569692, DOI: 10.1200/jco.2016.66.9929.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsObjective response ratePD-ligand 1 (PD-L1) expressionAdverse eventsOverall survivalNivolumab monotherapyAdvanced NSCLCLung cancerGrade 3Death-1 immune checkpoint inhibitor antibodyAdvanced non-small cell lung cancerGrade treatment-related adverse eventsNon-small cell lung cancerImmune checkpoint inhibitor antibodyProgression-free survival ratesCheckpoint inhibitor antibodyExploratory end pointsFirst tumor assessmentFirst-line monotherapyOngoing complete responseTolerable safety profileMedian overall survivalGrade 3 rashOnly grade 3Cell lung cancerNivolumab in Combination With Platinum‐Based Doublet Chemotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer
Rizvi NA, Hellmann MD, Brahmer JR, Juergens RA, Borghaei H, Gettinger S, Chow LQ, Gerber DE, Laurie SA, Goldman JW, Shepherd FA, Chen AC, Shen Y, Nathan FE, Harbison CT, Antonia S. Nivolumab in Combination With Platinum‐Based Doublet Chemotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2016, 34: 2969-2979. PMID: 27354481, PMCID: PMC5569693, DOI: 10.1200/jco.2016.66.9861.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarboplatinCarcinoma, Non-Small-Cell LungCisplatinCohort StudiesDeoxycytidineDisease-Free SurvivalDose-Response Relationship, DrugErbB ReceptorsFemaleGemcitabineHumansLung NeoplasmsMaleMiddle AgedNivolumabPemetrexedProto-Oncogene Proteins p21(ras)Survival RateConceptsPlatinum-based doublet chemotherapyTreatment-related adverse eventsProgression-free survival ratesDeath ligand 1 (PD-L1) expressionObjective response ratePercent of patientsLigand 1 expressionAdverse eventsPaclitaxel-carboplatinDoublet chemotherapyOverall survivalOS ratesLung cancerDeath-1 immune checkpoint inhibitor antibodyAdvanced non-small cell lung cancerResponse rateSurvival rateNon-small cell lung cancerImmune checkpoint inhibitor antibodyCheckpoint inhibitor antibodyEfficacy of nivolumabPaclitaxel-carboplatin groupDose-limiting toxicityCurrent standard therapyWeeks of treatment
2014
1054PD Nivolumab (Anti-Pd-1; Bms-936558, Ono-4538) in Combination with Platinum-Based Doublet Chemotherapy (Pt-Dc) or Erlotinib (Erl) in Advanced Non-Small Cell Lung Cancer (Nsclc)
Gettinger S, Rizvi N, Chow L, Borghaei H, Brahmer J, Juergens R, Shepherd F, Laurie S, Gerber D, Goldman J, Shen Y, Harbison C, Chen A, Antonia S. 1054PD Nivolumab (Anti-Pd-1; Bms-936558, Ono-4538) in Combination with Platinum-Based Doublet Chemotherapy (Pt-Dc) or Erlotinib (Erl) in Advanced Non-Small Cell Lung Cancer (Nsclc). Annals Of Oncology 2014, 25: iv363. DOI: 10.1093/annonc/mdu342.7.Peer-Reviewed Original ResearchObjective response rateBest overall responseProgression/unacceptable toxicityGrade 3Cisplatin 75Advanced NSCLCUnacceptable toxicityAdvanced non-small cell lung cancerDeath-1 immune checkpoint inhibitor antibodyChemotherapy-naïve NSCLC patientsImmune checkpoint inhibitor antibodyNon-small cell lung cancerProgression-free survival ratesRelated AEsCheckpoint inhibitor antibodyGenentech/RocheAcceptable safety profileDurable clinical benefitPhase 1 studyCell lung cancerAcceptable antitumor activityCarboplatin AUC6Doublet chemotherapyGemcitabine 1250Grade pneumonitis
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 toxicity