2020
CTIM-28. PHASE 2 TRIAL OF CONTROLLED IL-12 IN COMBINATION WITH PD-1 INHIBITOR IN ADULT SUBJECTS WITH RECURRENT GLIOBLASTOMA (rGBM)
Lukas R, Chiocca E, Bush N, Landolfi J, Cavaliere R, Yu J, Kurz S, Demars N, Buck J, Hadar N, Miao J, Loewy J, Wang Y, Gelb A, Cooper L. CTIM-28. PHASE 2 TRIAL OF CONTROLLED IL-12 IN COMBINATION WITH PD-1 INHIBITOR IN ADULT SUBJECTS WITH RECURRENT GLIOBLASTOMA (rGBM). Neuro-Oncology 2020, 22: ii39-ii39. PMCID: PMC7650356, DOI: 10.1093/neuonc/noaa215.162.Peer-Reviewed Original ResearchPD-1 inhibitorsImmune-mediated anti-tumor effectsAnti-tumor effectsRecurrent glioblastomaIL-12PD-1Overall survivalFollow-upIncreased PD-1 expressionIL-12 therapyPD-1 expressionPhase 2 trialPhase 1 trialPost-treatment biopsiesGene therapy candidateSurvival dataEndogenous cytokine productionIFN-g levelsTumor cell heterogeneityFunctional IL-12Blood-brain barrierCombination immunotherapyIT injectionSafety profileIFN-gLTBK-01. INO-5401 AND INO-9012 DELIVERED INTRAMUSCULARLY (IM) WITH ELECTROPORATION (EP) IN COMBINATION WITH CEMIPLIMAB (REGN2810) IN NEWLY DIAGNOSED GLIOBLASTOMA
Reardon D, Brem S, Desai A, Bagley S, Kurz S, De La Fuente M, Nagpal S, Welch M, Hormigo A, Forsyth P, Mandell J, Khagi S, Aiken R, Walbert T, Lieberman F, Portnow J, Batiste J, Carroll N, Sylvester A, Campbell P, Lowy I, Dolgoter A, Boyer J, Kraynyak K, Morrow M, McMullan T, Weiner D, Skolnik J. LTBK-01. INO-5401 AND INO-9012 DELIVERED INTRAMUSCULARLY (IM) WITH ELECTROPORATION (EP) IN COMBINATION WITH CEMIPLIMAB (REGN2810) IN NEWLY DIAGNOSED GLIOBLASTOMA. Neuro-Oncology 2020, 22: ii237-ii237. PMCID: PMC7678727, DOI: 10.1093/neuonc/noaa215.988.Peer-Reviewed Original ResearchCohort AMedian OSAntigen-specific T cell responsesImmune responseRobust systemic immune responsesInterferon-gamma ELISPOTDiagnosed GBM patientsT cell responsesEncoding tumor antigensAdverse event profileNewly diagnosed glioblastomaPeripheral immune responseSystemic immune responsesCheckpoint inhibitionPD-1Diagnosed GBMDiagnosed glioblastomaOverall survivalCohort B.Tumor antigensCD8+T cellsMedian agePrimary endpointCohort BEvent profileINO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma (GBM): Interim results.
Reardon D, Brem S, Desai A, Bagley S, Kurz S, De La Fuente M, Nagpal S, Welch M, Hormigo A, Carroll N, Bartra S, Campbell P, Bhatt K, Lowy I, Boyer J, Kraynyak K, Morrow M, McMullan T, Weiner D, Skolnik J. INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma (GBM): Interim results. Journal Of Clinical Oncology 2020, 38: 2514-2514. DOI: 10.1200/jco.2020.38.15_suppl.2514.Peer-Reviewed Original ResearchNewly-diagnosed GBMTumor inflammationCohort AT cell responsesNewly diagnosed glioblastomaWeeks of treatmentCheckpoint inhibitionPD-1Cohort B.Combination therapyPrimary endpointCD8+T cellsPhase I/IICohort BPlatelet countLymphocyte countSafety profileCemiplimabSurvival advantageCohort studyLytic potentialFlow cytometryPatientsGlioblastomaCohortP858 An open-label, multi-center trial of INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM)
Skolnik J, Reardon D, Brem S, Desai A, Bagley S, Kurz S, de la Fuente M, Nagpal S, Welch M, Sacchetta B, Bartra S, Bredlau A, Lowy I, Kraynyak K, Morrow M, McMullan T, Boyer J. P858 An open-label, multi-center trial of INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM). Journal For ImmunoTherapy Of Cancer 2020, 8: a8. DOI: 10.1136/lba2019.12.Peer-Reviewed Original ResearchNewly-diagnosed GBMCheckpoint inhibitorsCheckpoint inhibitionOverall survivalCohort ASafety profileClinical efficacyPD-1 checkpoint inhibitorsImmune-related AECycles of temozolomideT cell responsesNewly-diagnosed glioblastomaWeeks of treatmentPreliminary clinical efficacyMulti-center trialInstitutional ethics boardMaintenance temozolomidePD-1Open-labelCohort B.Median agePhase I/IICohort BCemiplimabAdverse events
2018
PD-1 inhibition has only limited clinical benefit in patients with recurrent high-grade glioma.
Kurz S, Cabrera L, Hastie D, Huang R, Unadkat P, Rinne M, Nayak L, Lee E, Reardon D, Wen P. PD-1 inhibition has only limited clinical benefit in patients with recurrent high-grade glioma. Neurology 2018, 91: e1355-e1359. PMID: 30171077, DOI: 10.1212/wnl.0000000000006283.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabBrain NeoplasmsFemaleGliomaHumansMaleMiddle AgedNeoplasm Recurrence, LocalNivolumabProgrammed Cell Death 1 ReceptorRetrospective StudiesSalvage TherapySurvival AnalysisTreatment OutcomeYoung AdultConceptsRecurrent high-grade gliomaHigh-grade gliomasRetrospective observational studySalvage therapySurvival benefitSingle-institution retrospective observational studyPD-1 blocking antibodiesObservational studyPD-1 inhibitionProgression-free survivalClass IV evidenceConcurrent bevacizumabAntibody nivolumabPD-1Median survivalClinical benefitImproved survivalNivolumabPembrolizumabAdult patientsBevacizumabIV evidenceClinical trialsPatient populationPatients