2023
Evaluation of the SSTR2-targeted Radiopharmaceutical 177Lu-DOTATATE and SSTR2-specific 68Ga-DOTATATE PET as Imaging Biomarker in Patients with Intracranial Meningioma.
Kurz S, Zan E, Cordova C, Troxel A, Barbaro M, Silverman J, Snuderl M, Zagzag D, Kondziolka D, Golfinos J, Chi A, Sulman E. Evaluation of the SSTR2-targeted Radiopharmaceutical 177Lu-DOTATATE and SSTR2-specific 68Ga-DOTATATE PET as Imaging Biomarker in Patients with Intracranial Meningioma. Clinical Cancer Research 2023, 30: 680-686. PMID: 38048045, DOI: 10.1158/1078-0432.ccr-23-2533.Peer-Reviewed Original ResearchConceptsProgression-free survivalSomatostatin receptor type 2PFS-6Stable diseaseOverall survivalIntracranial meningiomasSingle-arm phase II clinical studyMedian progression-free survivalPhase II clinical studyImaging biomarkersCourse of radiationReceptor type 2Multicenter clinical trialMacdonald criteriaMedian OSRadiographic responseProgressive meningiomasTumor measurementsTumor resectionMedian agePrimary endpointRadiotherapeutic interventionSecondary endpointsMedical therapyAdult patients
2020
LTBK-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 profileCTNI-37. EFFICACY OF ONC201 IN PATIENTS WITH ONC201 FOR RECURRENT H3 K27M-MUTANT DIFFUSE MIDLINE GLIOMA
Arrillaga-Romany I, Kurz S, Tarapore R, Sumrall A, Butowski N, Harrison R, de Groot J, Chi A, Shonka N, Umemura Y, Odia Y, Mehta M, Nghiemphu P, Cloughesy T, Taylor L, Graber J, Kilburn L, Dixit K, Lu G, Allen J, Batchelor T, Lassman A, Wen P. CTNI-37. EFFICACY OF ONC201 IN PATIENTS WITH ONC201 FOR RECURRENT H3 K27M-MUTANT DIFFUSE MIDLINE GLIOMA. Neuro-Oncology 2020, 22: ii50-ii51. PMCID: PMC7651099, DOI: 10.1093/neuonc/noaa215.204.Peer-Reviewed Original ResearchH3 K27M-mutant diffuse midline gliomaDiffuse midline gliomaRANO criteriaMidline gliomaFrequent drug-related adverse eventsDrug-related adverse eventsCentral radiology reviewContrast-enhancing diseaseObjective response rateProgression-free survivalCerebrospinal fluid disseminationGrade nauseaRadiographic regressionPrior radiationOverall survivalDismal prognosisDRD2 antagonistsMedian agePrimary lesionRadiological reviewMedian timeAdverse eventsT1 contrast enhancementClpP agonistsClinical studiesClinical experience of ONC201 in patients with recurrent H3 K27M-mutant spinal cord glioma.
Kurz S, Tarapore R, Odia Y, Butowski N, Koschmann C, Aguilera D, MacDonald T, Lu G, Allen J, Oster W, Mehta M, Chi A, Wen P. Clinical experience of ONC201 in patients with recurrent H3 K27M-mutant spinal cord glioma. Journal Of Clinical Oncology 2020, 38: 2563-2563. DOI: 10.1200/jco.2020.38.15_suppl.2563.Peer-Reviewed Original ResearchSingle agent groupSpinal cord tumorsCombination groupCord tumorsPediatric patientsSpinal cordH3 K27M mutationMedian survival time rangesMedian follow-up timePhase I clinical trialPhase II clinical trialK27M mutationSurvival time rangesClinical experienceSpinal cord gliomasFollow-up timeHigh-grade gliomasII clinical trialsDose reductionDRD2 antagonistsMedian ageProlonged survivalAgent groupDiffuse gliomasUnfavorable prognosisClinical efficacy of ONC201 in thalamic H3 K27M-mutant glioma.
Kawakibi A, Tarapore R, Gardner S, Kurz S, Wen P, Arrillaga-Romany I, Batchelor T, Butowski N, Sumrall A, Shonka N, Harrison R, De Groot J, Mehta M, Odia Y, Hall M, Cloughesy T, Ellingson B, Umemura Y, Allen J, Koschmann C. Clinical efficacy of ONC201 in thalamic H3 K27M-mutant glioma. Journal Of Clinical Oncology 2020, 38: 3617-3617. DOI: 10.1200/jco.2020.38.15_suppl.3617.Peer-Reviewed Original ResearchH3 K27M-mutant gliomasNon-recurrent patientsGlioma patientsRecurrent patientsClinical efficacyTreatment discontinuation due to toxicityDiscontinued due to toxicityMedian duration of responseH3 K27M-mutantDose-limiting toxicityDuration of responseDiffuse midline gliomaExpression of DRD2Wild-type gliomasAntitumor responseMedian followMidline gliomaPrimary tumorRecurrent diseaseDRD2 expressionMedian durationDRD2 antagonistsMedian ageTumor DNAMedian timeP858 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
2019
Single agent ONC201 in adult recurrent H3 K27M-mutant glioma.
Arrillaga I, Kurz S, Sumrall A, Butowski N, Harrison R, De Groot J, Shonka N, Lieberman F, Odia Y, Tarapore R, Merdinger K, Allen J, Oster W, Mehta M, Cloughesy T, Chi A, Lassman A, Batchelor T, Wen P. Single agent ONC201 in adult recurrent H3 K27M-mutant glioma. Journal Of Clinical Oncology 2019, 37: 3005-3005. DOI: 10.1200/jco.2019.37.15_suppl.3005.Peer-Reviewed Original ResearchH3 K27M-mutant gliomasResponse of stable diseaseStable diseaseMedian followTumor regressionTreatment discontinuation due to toxicitySingle agentDiscontinued due to toxicityMedian prior linesDose-limiting toxicityTreated with single agentsCompassionate use protocolProgression-freePrior radiationPartial responseConfirmatory scanDRD2 antagonistsMedian ageAssociated with improvementsProgressive diseaseTumor lesionsOn-treatmentAdult patientsPoor prognosisNeurological symptoms