2021
457 KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC)
Gutierrez M, Lam W, Hellmann M, Gubens M, Aggarwal C, Tan D, Felip E, Chiu J, Lee J, Yang J, Garon E, Finocchiaro G, Ahn M, Luft A, Landers G, Basso A, Ma H, Kobie J, Palcza J, Cristescu R, Fong L, Snyder A, Yuan J, Herbst R. 457 KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC). Journal For ImmunoTherapy Of Cancer 2021, 9: a485-a485. DOI: 10.1136/jitc-2021-sitc2021.457.Peer-Reviewed Original ResearchTreatment-related adverse eventsNon-small cell lung cancerAdvanced non-small cell lung cancerCombination therapyInterim analysisBiomarker subgroupsMost treatment-related adverse eventsT-cell-inflamed gene expression profileHigh subgroupBiomarker-defined subgroupsPrimary end pointPhase 2 studyPhase 2 trialFirst-line pembrolizumabCell lung cancerFirst interim analysisSubsidiary of MerckInstitutional review boardRECIST v1.1Data cutoffAdverse eventsDohme Corp.Lung cancerMature dataStudy protocol
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 treatment1589TiP KEYNOTE-495/KeyImPaCT: A randomized, biomarker-directed, phase II trial of pembrolizumab-based therapy for non–small cell lung cancer (NSCLC)
Gutierrez M, Lam W, Hellmann M, Gubens M, Aggarwal C, Tan D, Felip E, Chiu J, Lee J, Yang J, Garon E, Basso A, Ma H, Fong L, Snyder A, Yuan J, Herbst R. 1589TiP KEYNOTE-495/KeyImPaCT: A randomized, biomarker-directed, phase II trial of pembrolizumab-based therapy for non–small cell lung cancer (NSCLC). Annals Of Oncology 2019, 30: v656. DOI: 10.1093/annonc/mdz260.111.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPhase II trialSubsidiary of MerckDohme Corp.Boehringer IngelheimRECIST v1.1II trialMerck SharpEli LillyInvestigator-assessed objective response rateRoche/GenentechEnd pointECOG PS 0Genentech/RochePembrolizumab-based therapyObjective response ratePrimary end pointSecondary end pointsProgression-free survivalROS1 gene rearrangementTumor mutation burdenCell lung cancerAbsence of EGFRYears of age1482O Outcomes with pembrolizumab (pembro) monotherapy in patients (pts) with PD-L1–positive NSCLC with brain metastases: Pooled analysis of KEYNOTE-001, -010, -024, and -042
Mansfield A, Herbst R, Castro G, Hui R, Peled N, Kim D, Novello S, Satouchi M, Wu Y, Garon E, Reck M, Robinson A, Samkari A, Piperdi B, Ebiana V, Lin J, Mok T. 1482O Outcomes with pembrolizumab (pembro) monotherapy in patients (pts) with PD-L1–positive NSCLC with brain metastases: Pooled analysis of KEYNOTE-001, -010, -024, and -042. Annals Of Oncology 2019, 30: v604-v606. DOI: 10.1093/annonc/mdz260.004.Peer-Reviewed Original ResearchStable brain metastasesSubsidiary of MerckGenentech/RocheBrain metastasesDohme Corp.PD-L1Personal feesMerck SeronoPositive NSCLCEMD SeronoBoehringer IngelheimMerck SharpKEYNOTE-001Clovis OncologyData cutoffAdvisory board membersEli LillyRoche/GenentechMesothelioma Applied Research FoundationSeattle GeneticsVertex PharmaceuticalsAdvanced PD-L1Baseline brain metastasesBrain metastasis statusTreatment-related AEsLBA79 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 sequencing