2021
Outcomes With Pembrolizumab Monotherapy in Patients With Programmed Death-Ligand 1–Positive NSCLC With Brain Metastases: Pooled Analysis of KEYNOTE-001, 010, 024, and 042
Mansfield AS, Herbst RS, de Castro G, Hui R, Peled N, Kim DW, Novello S, Satouchi M, Wu YL, Garon EB, Reck M, Robinson AG, Samkari A, Piperdi B, Ebiana V, Lin J, Mok TSK. Outcomes With Pembrolizumab Monotherapy in Patients With Programmed Death-Ligand 1–Positive NSCLC With Brain Metastases: Pooled Analysis of KEYNOTE-001, 010, 024, and 042. JTO Clinical And Research Reports 2021, 2: 100205. PMID: 34590048, PMCID: PMC8474394, DOI: 10.1016/j.jtocrr.2021.100205.Peer-Reviewed Original ResearchBaseline brain metastasesPD-L1 TPSStable brain metastasesBrain metastasesKEYNOTE-001Metastatic NSCLCPembrolizumab monotherapyAdverse eventsPD-L1Treatment-related adverse eventsBrain metastasis statusEfficacy of pembrolizumabObjective response rateProgression-free survivalCell lung cancerDuration of responseKEYNOTE-010KEYNOTE-024KEYNOTE-042Data cutoffOverall survivalLung cancerMetastasis statusPresence of baselineChemotherapyFive Year Survival Update From KEYNOTE-010: Pembrolizumab Versus Docetaxel for Previously Treated, Programmed Death-Ligand 1–Positive Advanced NSCLC
Herbst RS, Garon EB, Kim DW, Cho BC, Gervais R, Perez-Gracia JL, Han JY, Majem M, Forster MD, Monnet I, Novello S, Gubens MA, Boyer M, Su WC, Samkari A, Jensen EH, Kobie J, Piperdi B, Baas P. Five Year Survival Update From KEYNOTE-010: Pembrolizumab Versus Docetaxel for Previously Treated, Programmed Death-Ligand 1–Positive Advanced NSCLC. Journal Of Thoracic Oncology 2021, 16: 1718-1732. PMID: 34048946, DOI: 10.1016/j.jtho.2021.05.001.Peer-Reviewed Original ResearchConceptsPD-L1 tumor proportion scoreTumor proportion scoreAdvanced NSCLCOverall survivalPembrolizumab improved overall survivalTissue tumor mutational burdenExploratory biomarker analysisImproved overall survivalProgrammed Death LigandTumor mutational burdenDocetaxel 75KEYNOTE-010Pembrolizumab dosesPembrolizumab treatmentSurvival updateData cutoffObjective responseHazard ratioOS ratesCare treatmentLong-term benefitsMedian studyImproved outcomesPembrolizumabProportion scoreFP13.01 5-Year Survival Update From KEYNOTE-010: Pembrolizumab Versus Docetaxel in Previously Treated, PD-L1–Positive Advanced NSCLC
Herbst R, Garon E, Kim D, Cho B, Gervais R, Perez-Gracia J, Han J, Majem M, Forster M, Monnet I, Novello S, Gubens M, Boyer M, Su W, Samkari A, Jensen E, Piperdi B, Baas P. FP13.01 5-Year Survival Update From KEYNOTE-010: Pembrolizumab Versus Docetaxel in Previously Treated, PD-L1–Positive Advanced NSCLC. Journal Of Thoracic Oncology 2021, 16: s223-s224. DOI: 10.1016/j.jtho.2021.01.140.Peer-Reviewed Original Research
2019
LBA79 Association between tissue TMB (tTMB) and clinical outcomes with pembrolizumab monotherapy (pembro) in PD-L1-positive advanced NSCLC in the KEYNOTE-010 and -042 trials
Herbst R, Lopes G, Kowalski D, Nishio M, Wu Y, de Castro G, Baas P, Kim D, Gubens M, Cristescu R, Aurora-Garg D, Albright A, Ayers M, Loboda A, Lunceford J, Kobie J, Lubiniecki G, Pietanza M, Piperdi B, Mok T. LBA79 Association between tissue TMB (tTMB) and clinical outcomes with pembrolizumab monotherapy (pembro) in PD-L1-positive advanced NSCLC in the KEYNOTE-010 and -042 trials. Annals Of Oncology 2019, 30: v916-v917. DOI: 10.1093/annonc/mdz394.077.Peer-Reviewed Original ResearchBristol-Myers SquibbTissue TMBGenentech/RocheSubsidiary of MerckDohme Corp.KEYNOTE-010KEYNOTE-042PD-L1Merck SeronoBoehringer IngelheimMerck SharpAdvanced NSCLCClinical outcomesEli LillyOno PharmaceuticalCox proportional hazards modelPositive advanced NSCLCResults Baseline characteristicsSubset of ptsOpen-label trialTotal study populationProportional hazards modelRoche/GenentechMultiple tumor typesWhole-exome sequencingUse of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: an updated analysis of KEYNOTE-010 trial
Herbst RS, Baas P, Perez-Gracia JL, Felip E, Kim D, Han J, Molina JR, Kim J, Arvis C, Ahn M, Majem M, Fidler MJ, Surmont V, de Castro G, Garrido M, Shentu Y, Emancipator K, Samkari A, Jensen EH, Lubiniecki GM, Garon EB. Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: an updated analysis of KEYNOTE-010 trial. Annals Of Oncology 2019, 30: 281-289. PMID: 30657853, PMCID: PMC6931268, DOI: 10.1093/annonc/mdy545.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBiopsyCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellDocetaxelFemaleFollow-Up StudiesHumansInternational AgenciesLung NeoplasmsMaleMiddle AgedParaffin EmbeddingPrognosisSpecimen HandlingSurvival RateYoung AdultConceptsTumor proportion scoreOS hazard ratioPD-L1 expressionProgression-free survivalPFS hazard ratioHazard ratioOverall survivalTumor samplesPD-L1PD-L1 tumor proportion scorePrespecified exploratory analysisPrimary end pointSubset of patientsCell lung cancerDeath 1 proteinArchival samplesDocetaxel 75KEYNOTE-010Pembrolizumab dosesRECIST v1.1Advanced NSCLCLung cancerProportion scorePatientsPrimary analysisHealth-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1–Expressing NSCLC
Barlesi F, Garon E, Kim D, Felip E, Han J, Kim J, Ahn M, Fidler M, Gubens M, de Castro G, Surmont V, Li Q, Deitz A, Lubiniecki G, Herbst R. Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1–Expressing NSCLC. Journal Of Thoracic Oncology 2019, 14: 793-801. PMID: 30711649, DOI: 10.1016/j.jtho.2019.01.016.Peer-Reviewed Original ResearchConceptsGlobal health statusDeath ligand 1Composite endpointPhase II/III studyGHS/QoL scoresLife Questionnaire Core 30Programmed Death Ligand 1Symptom domainsNSCLC patient populationPembrolizumab-treated patientsWeek 12 changesHealth-related qualityLigand 1Quality of lifeGHS/KEYNOTE-010Advanced NSCLCChest painIII studyOverall survivalCancer QualityEuroQol-5D.Life scoresMean baselinePatient population
2017
Factors associated with better overall survival (OS) in patients with previously treated, PD-L1–expressing, advanced NSCLC: Multivariate analysis of KEYNOTE-010.
Herbst R, Baas P, Kim D, Felip E, Perez-Gracia J, Han J, Molina J, Kim J, Dubos Arvis C, Ahn M, Majem M, Fidler M, Castro G, Garrido M, Ellison M, Samkari A, Lubiniecki G, Garon E. Factors associated with better overall survival (OS) in patients with previously treated, PD-L1–expressing, advanced NSCLC: Multivariate analysis of KEYNOTE-010. Journal Of Clinical Oncology 2017, 35: 9090-9090. DOI: 10.1200/jco.2017.35.15_suppl.9090.Peer-Reviewed Original ResearchOverall survivalKEYNOTE-010Advanced NSCLCPD-L1Multivariate analysisPembrolizumab armBetter OSHazard ratioCox proportional hazards regression modelNormal baseline lactate dehydrogenaseProportional hazards regression modelsBaseline lactate dehydrogenasePD-L1 TPSPositive advanced NSCLCSuperior overall survivalBetter overall survivalIndependent central reviewHazards regression modelsLactate dehydrogenaseEGFR mutation statusNonsquamous histologyRECIST v1.1Smoking statusTumor characteristicsCentral reviewEstimating long-term survival of PD-L1-expressing, previously treated, non-small cell lung cancer patients who received pembrolizumab in KEYNOTE-001 and -010.
Hellmann M, Ma J, Garon E, Hui R, Gandhi L, Soria J, Anderson K, Lubiniecki G, Piperdi B, Herbst R. Estimating long-term survival of PD-L1-expressing, previously treated, non-small cell lung cancer patients who received pembrolizumab in KEYNOTE-001 and -010. Journal Of Clinical Oncology 2017, 35: 77-77. DOI: 10.1200/jco.2017.35.7_suppl.77.Peer-Reviewed Original ResearchNon-small cell lung cancerLong-term survival ratesLong-term survivalAdvanced non-small cell lung cancerKEYNOTE-001KEYNOTE-010PD-L1Survival rateOverall survivalLong-term benefitsLong-term survival modelsNon-small cell lung cancer patientsCell lung cancer patientsPercentage of patientsSurvival modelsCell lung cancerLung cancer patientsTreat populationDocetaxel armPembrolizumab monotherapyParametric survival modelsCancer patientsLung cancerPatientsSubsequent independent validationOA03.07 KEYNOTE-010: Durable Clinical Benefit in Patients with Previously Treated, PD-L1-Expressing NSCLC Who Completed Pembrolizumab
Herbst R, Garon E, Kim D, Cho B, Gadgeel S, Léna H, Gúrpide A, Han J, Arvis C, Majem M, Forster M, Monnet I, Novello S, Saka H, Szalai Z, Gubens M, Su W, Lubiniecki G, Shentu Y, Ferraro G, Baas P. OA03.07 KEYNOTE-010: Durable Clinical Benefit in Patients with Previously Treated, PD-L1-Expressing NSCLC Who Completed Pembrolizumab. Journal Of Thoracic Oncology 2017, 12: s254-s255. DOI: 10.1016/j.jtho.2016.11.243.Peer-Reviewed Original Research
2016
LBA48 Pembrolizumab (pembro) vs docetaxel (doce) for previously treated, PD-L1–expressing NSCLC: Updated outcomes of KEYNOTE-010
Herbst R, Baas P, Kim D, Felip E, Pérez-Gracia J, Han J, Molina J, Kim J, Arvis C, Ahn M, Majem M, Fidler M, De Castro G, Garrido M, Shentu Y, Lubiniecki G, Garon E. LBA48 Pembrolizumab (pembro) vs docetaxel (doce) for previously treated, PD-L1–expressing NSCLC: Updated outcomes of KEYNOTE-010. Annals Of Oncology 2016, 27: vi583. DOI: 10.1093/annonc/mdw435.47.Peer-Reviewed Original Research1219P Assessment of health-related quality of life (HRQoL) in KEYNOTE-010: A phase 2/3 study of pembrolizumab vs docetaxel in patients with previously treated advanced NSCLC
Barlesi F, Garon E, Kim D, Felip E, Han J, Kim J, Ahn M, Fidler M, Gubens M, Castro G, Surmont V, Li Q, Deitz A, Lubiniecki G, Herbst R. 1219P Assessment of health-related quality of life (HRQoL) in KEYNOTE-010: A phase 2/3 study of pembrolizumab vs docetaxel in patients with previously treated advanced NSCLC. Annals Of Oncology 2016, 27: vi422. DOI: 10.1093/annonc/mdw383.19.Peer-Reviewed Original ResearchPembrolizumab vs docetaxel for previously treated advanced NSCLC with a PD-L1 tumor proportion score (TPS) 1%-49%: Results from KEYNOTE-010.
Garon E, Herbst R, Kim D, Felip E, Perez-Gracia J, Han J, Molina J, Kim J, Dubos Arvis C, Ahn M, Majem M, Fidler M, Gubens M, Castro G, Garrido M, Shentu Y, Im E, Lubiniecki G, Baas P. Pembrolizumab vs docetaxel for previously treated advanced NSCLC with a PD-L1 tumor proportion score (TPS) 1%-49%: Results from KEYNOTE-010. Journal Of Clinical Oncology 2016, 34: 9024-9024. DOI: 10.1200/jco.2016.34.15_suppl.9024.Peer-Reviewed Original Research