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-gINO-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 cytometryPatientsGlioblastomaCohortSurvival of subjects with recurrent glioblastoma receiving intratumoral administration of controlled IL-12 with limited exposure to dexamethasone.
Lukas R, Kurz S, Yu J, Landolfi J, Rao G, Amidei C, Buck J, Hadar N, Estupinan T, Miao J, Loewy J, Wang Y, Demars N, Gelb A, Cooper L. Survival of subjects with recurrent glioblastoma receiving intratumoral administration of controlled IL-12 with limited exposure to dexamethasone. Journal Of Clinical Oncology 2020, 38: 2564-2564. DOI: 10.1200/jco.2020.38.15_suppl.2564.Peer-Reviewed Original ResearchMedian overall survivalImpact of DexIL-12Intratumoral administrationIFN-gGrade III or IV gliomaImmune-mediated anti-tumor effectsLow-dose corticosteroidsAnti-tumor responsesSerum IL-12Time of resectionTumor response dataRecombinant IL-12Survival of subjectsAnti-tumor effectsExposure to dexamethasoneImmune system activationOverall survivalRecurrent glioblastomaIV gliomasControl edemaPreclinical modelsSafety profileInterleukin-12Historical controlsP858 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