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
2015
Phase III, randomized trial (CheckMate 057) of nivolumab (NIVO) versus docetaxel (DOC) in advanced non-squamous cell (non-SQ) non-small cell lung cancer (NSCLC).
Paz-Ares L, Horn L, Borghaei H, Spigel D, Steins M, Ready N, Chow L, Vokes E, Felip E, Holgado E, Barlesi F, Kohlhaeufl M, Rodriguez O, Burgio M, Fayette J, Gettinger S, Harbison C, Dorange C, Finckenstein F, Brahmer J. Phase III, randomized trial (CheckMate 057) of nivolumab (NIVO) versus docetaxel (DOC) in advanced non-squamous cell (non-SQ) non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2015, 33: lba109-lba109. DOI: 10.1200/jco.2015.33.18_suppl.lba109.Peer-Reviewed Original ResearchNon-squamous cell non-small cell lung cancerPlatinum-based doublet chemotherapyProgression-free survivalSuperior overall survivalPD-L1 expressionOverall survivalDeath-1 immune checkpoint inhibitor antibodyInvestigator-assessed objective response rateGlobal phase III studyImmune checkpoint inhibitor antibodyNon-small cell lung cancerRandomized phase III trialCheckpoint inhibitor antibodyDrug-related AEsObjective response rateSubsequent systemic therapyTrials of nivolumabPhase III studyPhase III trialsCell lung cancerTyrosine kinase inhibitorsQuality of lifeDoublet chemotherapyIII studyIII trialsOverall Survival and Long-Term Safety of Nivolumab (Anti–Programmed Death 1 Antibody, BMS-936558, ONO-4538) in Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer
Gettinger SN, Horn L, Gandhi L, Spigel DR, Antonia SJ, Rizvi NA, Powderly JD, Heist RS, Carvajal RD, Jackman DM, Sequist LV, Smith DC, Leming P, Carbone DP, Pinder-Schenck MC, Topalian SL, Hodi FS, Sosman JA, Sznol M, McDermott DF, Pardoll DM, Sankar V, Ahlers CM, Salvati M, Wigginton JM, Hellmann MD, Kollia GD, Gupta AK, Brahmer JR. Overall Survival and Long-Term Safety of Nivolumab (Anti–Programmed Death 1 Antibody, BMS-936558, ONO-4538) in Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2015, 33: 2004-2012. PMID: 25897158, PMCID: PMC4672027, DOI: 10.1200/jco.2014.58.3708.Peer-Reviewed Original ResearchConceptsOverall survivalLong-term safetyAdvanced NSCLCLung cancerDeath-1 immune checkpoint inhibitor antibodyAdvanced non-small cell lung cancerNon-small cell lung cancerImmune checkpoint inhibitor antibodyTreatment-related adverse eventsCheckpoint inhibitor antibodyTreatment-related deathsMedian overall survivalMedian response durationAdvanced solid tumorsPhase I trialCell lung cancerRandomized clinical trialsFurther clinical developmentHuman immunoglobulin G4Nivolumab 1Nivolumab monotherapyExpansion cohortLast doseNonsquamous NSCLCAdverse events
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