2021
Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆
Spigel D, Vicente D, Ciuleanu T, Gettinger S, Peters S, Horn L, Audigier-Valette C, Aranda N, Juan-Vidal O, Cheng Y, Zhang H, Shi M, Luft A, Wolf J, Antonia S, Nakagawa K, Fairchild J, Baudelet C, Pandya D, Doshi P, Chang H, Reck M. Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆. Annals Of Oncology 2021, 32: 631-641. PMID: 33539946, DOI: 10.1016/j.annonc.2021.01.071.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerRelapsed Small-Cell Lung CancerOverall survivalLung cancerMedian progression-free survivalTreatment-related adverse eventsBaseline lactate dehydrogenaseBaseline liver metastasesSecond-line nivolumabSelect baseline characteristicsTrials of nivolumabImproved overall survivalObjective response rateCombined positive scoreNew safety signalsProgression-free survivalPlatinum-based chemotherapyPrimary endpointAdverse eventsBaseline characteristicsLiver metastasesMedian durationStandard chemotherapySurvival benefitUnacceptable toxicity
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
2017
Nivolumab (N) plus ipilimumab (I) as first-line (1L) treatment for advanced (adv) NSCLC: 2-yr OS and long-term outcomes from CheckMate 012.
Goldman J, Antonia S, Gettinger S, Borghaei H, Brahmer J, Ready N, Gerber D, Chow L, Juergens R, Shepherd F, Laurie S, Geese W, Li A, Li X, Hellmann M. Nivolumab (N) plus ipilimumab (I) as first-line (1L) treatment for advanced (adv) NSCLC: 2-yr OS and long-term outcomes from CheckMate 012. Journal Of Clinical Oncology 2017, 35: 9093-9093. DOI: 10.1200/jco.2017.35.15_suppl.9093.Peer-Reviewed Original ResearchPD-L1 expressionComplete responsePD-L1Long-term OS benefitPD-L1 tumor expressionStage IIIB/IVTumor PD-L1 expressionChemotherapy-naive NSCLCECOG PS 0Experienced grade 3IIIB/IVManageable safety profileFirst-line treatmentPhase 1 studyLong-term survivorsLong-term outcomesMultiple tumor typesExploratory endpointsOS benefitAdvanced NSCLCPrimary endpointSecondary endpointsPS 0Unacceptable toxicityConsent withdrawal
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
2013
Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial.
Topalian S, Sznol M, Brahmer J, McDermott D, Smith D, Gettinger S, Taube J, Drake C, Pardoll D, Powderly J, Carvajal R, Sosman J, Atkins M, Antonia S, Spigel D, Lawrence D, Kollia G, Gupta A, Wigginton J, Hodi F. Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial. Journal Of Clinical Oncology 2013, 31: 3002-3002. DOI: 10.1200/jco.2013.31.15_suppl.3002.Peer-Reviewed Original ResearchAdvanced solid tumorsLong-term safetySolid tumorsNon-small cell lung cancerLong-term safety profileDrug-related AEsDrug-related pneumonitisCo-inhibitory receptorsPhase III trialsPhase I trialCell lung cancerOngoing clinical developmentActivated T cellsCohort expansionMedian OSRECIST 1.0Efficacy outcomesUnacceptable toxicityIII trialsDeath-1Dose escalationI trialPD-1G3/G4Safety profileA phase III comparative study of nivolumab (anti-PD-1; BMS-963558; ONO-4538) versus docetaxel in patients (pts) with previously treated advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC).
Gettinger S, Brahmer J, Rizvi N, Ready N, Chow L, Antonia S, Buyse M, Jassem J, Finckenstein F, Crinò L, Lynch T. A phase III comparative study of nivolumab (anti-PD-1; BMS-963558; ONO-4538) versus docetaxel in patients (pts) with previously treated advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: tps8121-tps8121. DOI: 10.1200/jco.2013.31.15_suppl.tps8121.Peer-Reviewed Original ResearchNon-squamous NSCLCOverall survivalTyrosine kinase inhibitorsPD-L1Maintenance therapyAdvanced diseaseLung cancerDisease progressionPlatinum-based doublet chemotherapyRecurrent non-squamous NSCLCPhase III comparative studyMedian overall survivalObjective response ratePhase III studyProgression-free survivalPhase 1 studyCell lung cancerDurable antitumor activityPD-1 receptorImmune checkpoint receptorsT cell activationDoublet chemotherapyNSCLC ptsOS benefitUnacceptable toxicity
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