2025
Determinants of 5-year survival in patients with advanced NSCLC with PD-L1≥50% treated with first-line pembrolizumab outside of clinical trials: results from the Pembro-real 5Y global registry
Cortellini A, Brunetti L, Di Fazio G, Garbo E, Pinato D, Naidoo J, Katz A, Loza M, Neal J, Genova C, Gettinger S, Kim S, Jayakrishnan R, Zarif T, Russano M, Pecci F, Di Federico A, Awad M, Alessi J, Montrone M, Owen D, Signorelli D, Fidler M, Li M, Camerini A, De Giglio A, Young L, Vincenzi B, Metro G, Passiglia F, Yendamuri S, Guida A, Ghidini M, Awosika N, Napolitano A, Fulgenzi C, Grisanti S, Grossi F, D’Incecco A, Josephides E, Van Hemelrijck M, Russo A, Gelibter A, Spinelli G, Verrico M, Tomasik B, Giusti R, Newsom-Davis T, Bria E, Sebastian M, Rost M, Forster M, Mukherjee U, Landi L, Mazzoni F, Aujayeb A, Dupont M, Curioni-Fontecedro A, Chiari R, Pantano F, Morabito A, Leonetti A, Friedlaender A, Addeo A, Zoratto F, De Tursi M, Cantini L, Roca E, Mountzios G, Della Gravara L, Kalvapudi S, Inno A, Bironzo P, Di Marco Barros R, O’Reilly D, Bell J, Karapanagiotou E, Monnet I, Baena J, Macerelli M, Majem M, Agustoni F, Cortinovis D, Tonini G, Minuti G, Bennati C, Mezquita L, Gorría T, Servetto A, Beninato T, Russo G, Rogado J, Moliner L, Biello F, Nana F, Dingemans A, Aerts J, Ferrara R, Torri V, Abu Hejleh T, Takada K, Naqash A, Garassino M, Peters S, Wakelee H, Nassar A, Ricciuti B. Determinants of 5-year survival in patients with advanced NSCLC with PD-L1≥50% treated with first-line pembrolizumab outside of clinical trials: results from the Pembro-real 5Y global registry. Journal For ImmunoTherapy Of Cancer 2025, 13: e010674. PMID: 39904562, PMCID: PMC11795382, DOI: 10.1136/jitc-2024-010674.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerProgrammed cell death ligand 1Eastern Cooperative Oncology Group performance statusData cut-offLong-term efficacyIndividual patient-level dataMedian OSPembrolizumab monotherapySurvival rateProgressive diseaseDiscontinued treatment due to progressive diseaseTreated with first-line pembrolizumabClinical trialsPredictors of 5-year survivalFirst-line pembrolizumab monotherapyCell death ligand 1Pre-existing autoimmune diseaseFirst-line pembrolizumabKEYNOTE-024 trialPD-L1 TPSPermanently discontinue treatmentDeath-ligand 1Efficacy of pembrolizumabMedian Follow-Up
2024
First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial
Ren S, Wang X, Han B, Pan Y, Zhao J, Cheng Y, Hu S, Liu T, Li Y, Cheng Y, Feng J, Yi S, Gu S, Gao S, Luo Y, Liu Y, Liu C, Duan H, Wang S, Yang X, Fan J, Zhou C. First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial. Journal For ImmunoTherapy Of Cancer 2024, 12: e007227. PMID: 38388167, PMCID: PMC10882294, DOI: 10.1136/jitc-2023-007227.Peer-Reviewed Original ResearchConceptsMetastatic NSCLC patientsDisease control rateProgression-free survivalFirst-line treatmentNSCLC patientsOS ratesPD-L1Overall survivalOpen-labelSafety profileTreatment-related adverse events of grade 3Adverse events of grade 3Combination of immune-checkpoint inhibitorsEvents of grade 3Median progression-free survivalPhase 2 basket trialProgrammed death-ligand 1Treatment-related adverse eventsGrade 5 hemoptysisImmune-checkpoint inhibitorsPD-L1 TPSSafety of camrelizumabSolid Tumors V.1.1Death-ligand 1Response Evaluation Criteria
2022
A phase II study of talazoparib plus avelumab in patients with stage IV or recurrent nonsquamous non–small cell lung cancer bearing pathogenic STK11 genomic alterations (SWOG S1900C, LUNG-MAP sub-study, NCT04173507).
Skoulidis F, Redman M, Suga J, Al Baghdadi T, Villano J, Goldberg S, Villaruz L, Minichiello K, Gandara D, Herbst R, Kelly K. A phase II study of talazoparib plus avelumab in patients with stage IV or recurrent nonsquamous non–small cell lung cancer bearing pathogenic STK11 genomic alterations (SWOG S1900C, LUNG-MAP sub-study, NCT04173507). Journal Of Clinical Oncology 2022, 40: 9060-9060. DOI: 10.1200/jco.2022.40.16_suppl.9060.Peer-Reviewed Original ResearchObjective response ratePhase II studyCheckpoint inhibitorsII studyStage IVPrior linesGenomic alterationsSingle-arm phase II studyArm phase II studyBest objective response rateMedian progression-free survivalPARP inhibitorsAdequate organ functionCo-primary objectivesDurable disease stabilizationMost grade 3PD-L1 TPSDisease control rateImmune checkpoint inhibitorsMedian overall survivalNon-squamous NSCLCStage IV diseaseProgression-free survivalBest objective responseOptimal therapeutic approach
2021
364 KRAS mutations in patients with nonsquamous non–small-cell lung cancer: prevalence and relationship with PD-L1 expression, tumor mutation burden and smoking status
Garassino M, Rodriguez-Abreu D, Gadgeel S, Kowalski D, Kasahara K, Felip E, Wu Y, de Castro G, Cho B, Turna H, Horinouchi H, Reck M, Hui R, Garon E, Boyer M, Mok T, Lopes G, Kobie J, Li Y, Ayers M, Cristescu R, Zhao B, Pietanza M, Herbst R. 364 KRAS mutations in patients with nonsquamous non–small-cell lung cancer: prevalence and relationship with PD-L1 expression, tumor mutation burden and smoking status. Journal For ImmunoTherapy Of Cancer 2021, 9: a391-a391. DOI: 10.1136/jitc-2021-sitc2021.364.Peer-Reviewed Original ResearchPD-L1 TPSKRAS G12C mutationPD-L1 expressionPlatinum-based chemotherapyTumor PD-L1 expressionEGFR/ALK alterationsFirst-line therapyNon-squamous NSCLCNonsquamous NSCLCTumor mutation burdenPembrolizumab monotherapyKRAS mutational statusKEYNOTE-042KEYNOTE-189KRAS mutationsFormer smokersG12C mutationPatient characteristicsALK alterationsPD-L1Smoking statusMutation burdenKRAS G12CHigh tumor PD-L1 expressionMutational statusOutcomes 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 baselineChemotherapy
2020
Association of an RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial.
Yap T, Gainor J, Burris H, Kummar S, Pachynski R, Callahan M, LoRusso P, Tykodi S, Gibney G, Falchook G, Rahma O, Seiwert T, Papadopoulos K, Mier J, Hashambhoy-Ramsay Y, Felitsky D, Lee D, McGrath L, Harvey C, Hooper E. Association of an RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial. Journal Of Clinical Oncology 2020, 38: 14-14. DOI: 10.1200/jco.2020.38.5_suppl.14.Peer-Reviewed Original ResearchCD4 T cellsCD4 T effector cellsT effector cellsT cellsRNA signatureRECIST responseClinical outcomesEffector cellsTumor biopsiesPre-treatment tumor biopsiesCD4 T cell populationBaseline tumor biopsiesPD-L1 TPSPD-1 inhibitorsAdvanced solid tumorsRetrospective subset analysisImmune cell infiltrationPotential predictive biomarkersT cell populationsPD-L1 IHCActivated T cellsBaseline tumorEfficacy outcomesPD-L1Combo therapy
2019
LBA4 Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced non-squamous NSCLC in Keynote-042
Herbst R, Lopes G, Kowalski D, Kasahara K, Wu Y, De Castro G, Cho B, Turna H, Cristescu R, Aurora-Garg D, Lunceford J, Kobie J, Ayers M, Pietanza M, Piperdi B, Mok T. LBA4 Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced non-squamous NSCLC in Keynote-042. Annals Of Oncology 2019, 30: xi63-xi64. DOI: 10.1093/annonc/mdz453.001.Peer-Reviewed Original ResearchTumor mutational burdenNon-squamous NSCLCKRAS mutational statusAdvanced non-squamous NSCLCFirst-line therapyWhole-exome sequencingKRAS mutationsPembrolizumab monotherapyPD-L1Mutational statusSubsidiary of MerckBoehringer IngelheimMerck SharpBristol-Myers SquibbDohme Corp.Merck SeronoStandard first-line treatment optionFirst-line treatment optionEli LillyAdvanced PD-L1Genentech/RocheNon-squamous histologyPD-L1 TPSPD-L1 expressionFirst-line treatment
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 review
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