1589TiP 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 AEsLBA78 IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC
Spigel D, de Marinis F, Giaccone G, Reinmuth N, Vergnenegre A, Barrios C, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Mocci S, McCleland M, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, Jassem J, Herbst R. LBA78 IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC. Annals Of Oncology 2019, 30: v915. DOI: 10.1093/annonc/mdz293.Peer-Reviewed Original ResearchTreatment-related AEsPD-L1 expressionPD-L1F. Hoffmann-La RocheBristol-Myers SquibbHoffmann-La RocheBoehringer IngelheimArm ACisplatin 75mg/m2Interim overall survival analysisTumor PD-L1 statusTumor-infiltrating immune cellsPD-L1/PDEli LillyCarboplatin AUC 6ECOG PS 0Primary efficacy populationUnexpected safety signalsPD-L1 statusFirst-line treatmentPhase III studyPlatinum-based chemotherapyOverall survival analysisRoche/GenentechBristol-Meyers SquibbLBA79 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