2024
Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study
Iyer S, Sica R, Ho P, Prica A, Zain J, Foss F, Hu B, Beitinjaneh A, Weng W, Kim Y, Khodadoust M, Huen A, Williams L, Ma A, Huang E, Ganpule A, Nagar S, Sripakdeevong P, Cullingford E, Karnik S, Dequeant M, Patel J, He X, Li Z, He Q, Mendonez J, Keegan A, Horwitz S. Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study. The Lancet Oncology 2024 PMID: 39617017, DOI: 10.1016/s1470-2045(24)00508-4.Peer-Reviewed Original ResearchT-cell lymphomaPeripheral T-cell lymphomaCutaneous T-cell lymphomaRefractory T-cell lymphomaEastern Cooperative Oncology GroupChimeric antigen receptorCytokine release syndromeCAR+ T cellsSerious adverse eventsAdverse eventsT cellsOpen-labelRefractory peripheral T-cell lymphomaAllogeneic chimeric antigen receptorHealthy donor T cellsRefractory T-cell malignanciesCAR-T cell therapyMedian patient follow-upIncidence of adverse eventsDonor T cellsObjective response rateSystemic therapy linesDose-limiting toxicityT-cell therapyDose-escalation study
2023
Valemetostat for Relapsed or Refractory Peripheral T-Cell Lymphomas: Primary Results from a Phase 1 Trial
Jacobsen E, Maruyama D, Porcu P, Tobinai K, Allen P, Ishitsuka K, Tsukasaki K, Kusumoto S, Foss F, Yamauchi N, Morishima S, Imaizumi Y, Izutsu K, Feldman T, Kawamata T, Kakurai Y, Yamauchi H, Biserna N, Inoue A, Tsutsumi S, Horwitz S. Valemetostat for Relapsed or Refractory Peripheral T-Cell Lymphomas: Primary Results from a Phase 1 Trial. Blood 2023, 142: 303. DOI: 10.1182/blood-2023-172512.Peer-Reviewed Original ResearchPeripheral T-cell lymphomaAdult T-cell leukemia/lymphomaT-cell non-Hodgkin lymphomaObjective response rateDuration of responseProgression-free survivalT-cell lymphomaMedian DORATLL groupPTCL groupData cutoffAdverse eventsClinical activityResponse rateRefractory peripheral T-cell lymphomaMedian progression-free survivalAngioimmunoblastic T-cell lymphomaT-cell leukemia/lymphomaDose-expansion cohortsDose-expansion phaseMedian prior therapiesPreliminary efficacy assessmentComplete response rateDose-escalation phasePhase 2 trial
2021
Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial
Cowan R, Scarisbrick J, Zinzani P, Nicolay J, Sokol L, Pinter‐Brown L, Quaglino P, Iversen L, Dummer R, Musiek A, Foss F, Ito T, Rosen J, Medley M. Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial. Journal Of The European Academy Of Dermatology And Venereology 2021, 35: 2225-2238. PMID: 34273208, PMCID: PMC9290719, DOI: 10.1111/jdv.17523.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalBlood tumor burdenSézary syndromeMycosis fungoidesB2 patientsBlood involvementTumor burdenInvestigator-assessed progression-free survivalSuperior objective response rateTreatment-emergent adverse eventsRefractory mycosis fungoidesGreater clinical benefitCD8 ratioAdverse eventsSystemic therapyClinical benefitMogamulizumabPatient responseSustained reductionNext treatmentPatientsResponse rateCell countVorinostatSGNTGT-001: A phase 1 study of SEA-TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies (trial in progress).
Garralda E, Sanborn R, Minchom A, Davar D, Curigliano G, Ribrag V, Mehta A, Foss F, Zain J, Forero-Torres A, Ansell S. SGNTGT-001: A phase 1 study of SEA-TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies (trial in progress). Journal Of Clinical Oncology 2021, 39: tps2657-tps2657. DOI: 10.1200/jco.2021.39.15_suppl.tps2657.Peer-Reviewed Original ResearchAnti-tumor immune responseInhibitory immune checkpoint receptorsRegulatory cell depletionObjective response ratePhase II doseProgression-free survivalDose-limiting toxicityMetastatic solid tumorsPhase 1 studyT cell responsesT cell immunoreceptorImmune checkpoint receptorsImmune cell activationPK-PD correlationsAnti-tumor activityExpansion cohortPrimary endpointSecondary endpointsAdvanced malignanciesAdverse eventsLaboratory abnormalitiesMemory CD8Overall survivalComplete responseNK cells
2019
Outcomes for Relapsed and Refractory Peripheral T-Cell Lymphoma Patients after Front-Line Therapy from the COMPLETE Registry
Lansigan F, Horwitz SM, Pinter-Brown LC, Rosen ST, Pro B, Hsi ED, Federico M, Gisselbrecht C, Schwartz M, Bellm LA, Acosta M, Shustov AR, Advani RH, Feldman T, Lechowicz MJ, Smith SM, Tulpule A, Craig MD, Greer JP, Kahl BS, Leach JW, Morganstein N, Casulo C, Park SI, Foss FM. Outcomes for Relapsed and Refractory Peripheral T-Cell Lymphoma Patients after Front-Line Therapy from the COMPLETE Registry. Acta Haematologica 2019, 143: 40-50. PMID: 31315113, DOI: 10.1159/000500666.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaFront-line therapyComplete responseRelapsed diseaseT-cell lymphomaRefractory patientsInitial treatmentPrimary refractoryOverall survivalPeripheral T-cell lymphoma patientsResponse/stable diseaseT-cell lymphoma patientsAggressive T-cell lymphomaSingle-agent regimensDays of enrollmentObjective response ratePrimary refractory diseaseSecond-line settingSecond-line therapyActive single agentProspective outcome dataSingle-agent therapyLonger overall survivalUnmet medical needGood response
2016
Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T‐cell lymphoma
Foss F, Pro B, Prince H, Sokol L, Caballero D, Horwitz S, Coiffier B. Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T‐cell lymphoma. Cancer Medicine 2016, 6: 36-44. PMID: 27981793, PMCID: PMC5269566, DOI: 10.1002/cam4.939.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaLines of therapyLong-term outcomesT-cell lymphomaPrior therapyAdverse eventsTreatment of PTCLPivotal phase 2 trialAggressive non-Hodgkin lymphomaLast prior therapyObjective response rateFirst-line treatmentPhase 2 trialUnconfirmed complete responseLine of treatmentNon-Hodgkin lymphomaUse of romidepsinDisease refractorySalvage treatmentDose modificationMedian durationMost patientsPrior linesComplete responseClinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides
Foss F, Duvic M, Lerner A, Waksman J, Whittaker S. Clinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides. Clinical Lymphoma Myeloma & Leukemia 2016, 16: 637-643. PMID: 27637428, DOI: 10.1016/j.clml.2016.08.009.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaFolliculotropic mycosis fungoidesPrevious systemic therapyMycosis fungoidesDisease involvementCutaneous tumorsTumor stageSystemic therapyRefractory cutaneous T-cell lymphomaSubtypes of CTCLSafety of romidepsinObjective response ratePhase II studyAggressive disease courseReview of diagnosisT-cell lymphomaHistone deacetylase inhibitorsII studyComposite endpointDisease courseHistology reportsClinical efficacyUncommon subtypeFavorable outcomePatientsRomidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial
Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. Journal Of Hematology & Oncology 2016, 9: 22. PMID: 26965915, PMCID: PMC4785666, DOI: 10.1186/s13045-016-0243-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesDisease ProgressionDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFatigueFemaleHistone Deacetylase InhibitorsHumansLymphoma, T-Cell, PeripheralMaleMiddle AgedNauseaNeoplasm Recurrence, LocalNeutropeniaRemission InductionTime FactorsTreatment OutcomeYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaStable diseaseT-cell lymphomaClinical benefitPivotal trialsCell lymphomaDay 1Good responseLong stable diseaseObjective response rateProgression-free survivalUnconfirmed complete responseT-cell malignanciesHistone deacetylase inhibitorsProlonged dosingDurable responsesMedian durationObjective responsePartial responseComplete responseCurrent therapiesProtocol amendmentCell malignanciesPatients
2015
Romidepsin for the Treatment of Peripheral T‐Cell Lymphoma
Iyer SP, Foss FF. Romidepsin for the Treatment of Peripheral T‐Cell Lymphoma. The Oncologist 2015, 20: 1084-1091. PMID: 26099743, PMCID: PMC4571813, DOI: 10.1634/theoncologist.2015-0043.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaT-cell lymphomaHistone deacetylase inhibitorsPrior therapySpecialty centersTherapeutic approachesExpert hematopathologistsTreatment of PTCLDeacetylase inhibitorsPivotal phase II studiesCutaneous T-cell lymphomaPrior systemic therapyCommon adverse eventsObjective response ratePhase II studyFirst-line treatmentTreatment of patientsNon-Hodgkin lymphomaDifficulty of diagnosisAsthenic conditionsHeavy pretreatmentInduction chemotherapyAdvanced diseaseAdverse eventsUtility of18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma
Horwitz S, Coiffier B, Foss F, Prince HM, Sokol L, Greenwood M, Caballero D, Morschhauser F, Pinter-Brown L, Iyer SP, Shustov A, Nichols J, Balser J, Balser B, Pro B. Utility of18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma. Annals Of Oncology 2015, 26: 774-779. PMID: 25605745, PMCID: PMC4374388, DOI: 10.1093/annonc/mdv010.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaInternational Workshop CriteriaFDG-PET scansRefractory peripheral T-cell lymphomaBaseline FDG-PET scanCR/CRuT-cell lymphomaPositron emission tomographyConventional radiologyPET criteriaStable diseaseEnd pointFDG-PETConventional stagingPET statusResponse assessmentPivotal phase 2 trialEmission tomographyDeoxyglucose positron emission tomographyExploratory end pointsObjective response ratePET-positive diseasePrimary end pointProgression-free survivalPhase 2 study
2014
A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma
Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben‐Yehuda D, Beylot‐Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma. British Journal Of Haematology 2014, 168: 811-819. PMID: 25404094, DOI: 10.1111/bjh.13222.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsDrug Administration ScheduleFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsInfusions, IntravenousLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm StagingRecurrenceSulfonamidesTreatment OutcomeYoung AdultConceptsCutaneous T-cell lymphomaPeripheral T-cell lymphomaObjective response rateT-cell lymphomaPrior systemic therapyStage IV diseaseSystemic therapyAdverse eventsTreatment-related serious adverse eventsRefractory peripheral T-cell lymphomaTreatment-related adverse eventsPan-histone deacetylase inhibitorInfusion site painSkin-directed therapiesGrade 4 thrombocytopeniaSerious adverse eventsPhase II trialJugular vein thrombosisAnti-angiogenic propertiesOpen labelII trialParalytic ileusPeripheral edemaPrimary endpointSite painRomidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses
Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. Journal Of Hematology & Oncology 2014, 7: 11. PMID: 24456586, PMCID: PMC4016573, DOI: 10.1186/1756-8722-7-11.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibiotics, AntineoplasticCellulitisDepsipeptidesDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansInfusions, IntravenousLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalProspective StudiesRemission InductionTime FactorsTreatment OutcomeVenous ThrombosisVomitingConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaCR/CRuDuration of responseObjective response rateT-cell lymphomaDurable responsesPrior therapySystemic therapyMedian DORMedian progression-free survivalCutaneous T-cell lymphomaReported safety profileProgression-free survivalUnconfirmed complete responseSubset of patientsLong-term responseIndependent review committeeTreatment of patientsSelective histone deacetylase inhibitorsHistone deacetylase inhibitorsLack of responseHeavy pretreatmentStable diseasePrimary endpoint
2012
Pralatrexate Is an Effective Treatment for Relapsed or Refractory Transformed Mycosis Fungoides: A Subgroup Efficacy Analysis From the PROPEL Study
Foss F, Horwitz SM, Coiffier B, Bartlett N, Popplewell L, Pro B, Pinter-Brown LC, Shustov A, Furman RR, Haioun C, Koutsoukos T, O'Connor OA. Pralatrexate Is an Effective Treatment for Relapsed or Refractory Transformed Mycosis Fungoides: A Subgroup Efficacy Analysis From the PROPEL Study. Clinical Lymphoma Myeloma & Leukemia 2012, 12: 238-243. PMID: 22542448, DOI: 10.1016/j.clml.2012.01.010.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalToxicity-related discontinuationProgression-free survivalIndependent central reviewMedian survivalInvestigator assessmentMycosis fungoidesCentral reviewMedian durationAggressive diseaseRetrospective analysisGrade 4 adverse eventsPrior systemic therapySubgroup efficacy analysesObjective response rateTransformed Mycosis FungoidesPROPEL StudyAdverse eventsObjective responseSystemic therapyCutaneous lesionsEfficacy analysisPoor prognosisTreatment optionsMedian numberResults From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy
Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy. Journal Of Clinical Oncology 2012, 30: 631-636. PMID: 22271479, DOI: 10.1200/jco.2011.37.4223.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesDiarrheaDisease-Free SurvivalDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalPneumoniaTreatment OutcomeVascular DiseasesVomitingYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaPrior systemic therapyCR/CRuSystemic therapyT-cell lymphomaPrior therapyComplete response/unconfirmed complete responseResponse ratePrior stem cell transplantationEfficacy of romidepsinSingle-agent romidepsinObjective response ratePhase II studyPrimary end pointPhase II trialUnconfirmed complete responseStem cell transplantationIndependent review committeeDrug Administration approvalSelective histone deacetylase inhibitorsHistone deacetylase inhibitorsManageable toxicityII trialOpen label
2007
Phase IIB Multicenter Trial of Vorinostat in Patients With Persistent, Progressive, or Treatment Refractory Cutaneous T-Cell Lymphoma
Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIB Multicenter Trial of Vorinostat in Patients With Persistent, Progressive, or Treatment Refractory Cutaneous T-Cell Lymphoma. Journal Of Clinical Oncology 2007, 25: 3109-3115. PMID: 17577020, DOI: 10.1200/jco.2006.10.2434.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansHydroxamic AcidsLymphoma, T-Cell, CutaneousMaleMaximum Tolerated DoseMiddle AgedNeoplasm StagingProbabilitySalvage TherapySkin NeoplasmsSurvival AnalysisTreatment OutcomeVorinostatConceptsObjective response rateDuration of responseMF/SSStage IIBAdverse experiencesOral vorinostatPruritus reliefHigh patientCommon drug-related adverse experiencesRefractory cutaneous T-cell lymphomaMedian DORDrug-related adverse experiencesCutaneous T-cell lymphomaEnd pointT-cell lymphoma subtypesPrior systemic therapyStage IIB diseasePrimary end pointSecondary end pointsAcceptable safety profileHistone deacetylase inhibitor vorinostatPhase IIb trialT-cell lymphomaRecurrent mycosis fungoidesIIB disease
2002
A Phase II Trial of Daily Perillyl Alcohol in Patients with Advanced Ovarian Cancer: Eastern Cooperative Oncology Group Study E2E96
Bailey HH, Levy D, Harris LS, Schink JC, Foss F, Beatty P, Wadler S. A Phase II Trial of Daily Perillyl Alcohol in Patients with Advanced Ovarian Cancer: Eastern Cooperative Oncology Group Study E2E96. Gynecologic Oncology 2002, 85: 464-468. PMID: 12051875, DOI: 10.1006/gyno.2002.6647.Peer-Reviewed Original ResearchConceptsProgression-free rateAdvanced ovarian cancerOvarian cancerPerillyl alcoholMedian progression-free survivalPrior platinum-based therapyAdvanced ovarian carcinomaMedian overall survivalObjective response ratePhase II studyPhase II trialProgression-free survivalLDL cholesterol levelsPlatinum-based therapyGastrointestinal toxicityII trialPrimary endpointRecurrent diseaseUnacceptable toxicityII studyOverall survivalPartial responseHistoric controlsCholesterol levelsOvarian carcinoma