2024
TCL-391 Valemetostat Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas: Primary Results From a Phase 1 Trial
Maruyama D, Porcu P, Tobinai K, Allen P, Ishitsuka K, Tsukasaki K, Kusumoto S, Narita T, Foss F, Yamauchi N, Yuda J, Morishima S, Imaizumi Y, Izutsu K, Feldman T, Kawamata T, Kakurai Y, Yamauchi H, Biserna N, Maruyama A, Tachibana M, Hizukuri Y, Horwitz S, Jacobsen E. TCL-391 Valemetostat Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas: Primary Results From a Phase 1 Trial. Clinical Lymphoma Myeloma & Leukemia 2024, 24: s523-s524. DOI: 10.1016/s2152-2650(24)01617-3.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsB-NHLR/R NHLPartial responseEZH2 mutationsAdverse eventsMedian duration of responseRecommended phase 2 doseRelapsed/refractory non-Hodgkin lymphomaTreatment-related adverse eventsPhase 2 doseR/R follicular lymphomaNon-Hodgkin's lymphomaDuration of responseMaximum tolerated doseDecreased platelet countPhase 1 trialYears of ageFollicular lymphomaTolerated doseDose reductionOpen-labelMedian durationEfficacy analysisMedian agePhase 2 trial of the farnesyltransferase inhibitor tipifarnib for relapsed/refractory peripheral T-cell lymphoma
Witzig T, Sokol L, Kim W, de la Cruz Vicente F, García-Sancho A, Advani R, Vidal J, de Oña Navarrete R, Marin-Niebla A, Izquierdo A, Terol M, Domingo-Domenech E, Saunders A, Bendris N, Mackey J, Leoni M, Foss F. Phase 2 trial of the farnesyltransferase inhibitor tipifarnib for relapsed/refractory peripheral T-cell lymphoma. Blood Advances 2024, 8: 4581-4592. PMID: 38991123, PMCID: PMC11401221, DOI: 10.1182/bloodadvances.2024012806.Peer-Reviewed Original ResearchRelapsed/refractory peripheral T-cell lymphomaAngioimmunoblastic T-cell lymphomaPeripheral T-cell lymphomaT-cell lymphomaProgression-free survivalDuration of responseAdverse eventsAngioimmunoblastic T-cell lymphoma patientsMedian duration of responseMedian progression-free survivalSafety of tipifarnibHematologic adverse eventsMedian overall survivalTreatment-related deathsBiomarkers of responsePhase 2 trialSixty-five patientsFarnesyltransferase inhibitor tipifarnibNon-responder groupTumor mutational profileSingle-arm trialPTCL-NOSOpen-labelOverall survivalPrimary endpoint
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
Final Results from a Phase 2 Study of Tipifarnib in Subjects with Relapsed or Refractory Peripheral T-Cell Lymphoma
Witzig T, Sokol L, Kim W, de la Cruz Vicente F, Caballero D, Advani R, de Oña R, Niebla A, Terol M, Eva D, Bendris N, Ahsan J, Leoni M, Foss F. Final Results from a Phase 2 Study of Tipifarnib in Subjects with Relapsed or Refractory Peripheral T-Cell Lymphoma. Blood 2021, 138: 621. DOI: 10.1182/blood-2021-147279.Peer-Reviewed Original ResearchAngioimmunoblastic T-cell lymphomaProgression-free survivalOverall response rateT-cell lymphomaOverall survivalPeripheral T-cell lymphomaT-cell non-Hodgkin lymphomaOpen-label trialPhase 2 studyNegative prognostic factorDuration of responsePotential predictive biomarkersNon-Hodgkin lymphomaT-cell homingProgression of diseasePTCL patientsRefractory PTCLUnacceptable toxicityAdult patientsPrognostic factorsPredictive biomarkersLugano classificationCXCL12 expressionReceptor CXCR4New therapiesNovel Single Agents Are Equivalent to Conventional Chemotherapy Inpatients with Relapsed and Refractory Mature T-Cell Lymphomas: A Meta-Analysis
Shafagati N, Stuver R, Boussi L, Koh M, Park A, Bain P, Foss F, Shen C, Jain S. Novel Single Agents Are Equivalent to Conventional Chemotherapy Inpatients with Relapsed and Refractory Mature T-Cell Lymphomas: A Meta-Analysis. Blood 2021, 138: 1431. DOI: 10.1182/blood-2021-150315.Peer-Reviewed Original ResearchOverall response rateT-cell lymphomaHistological subtypesNovel single agentsSingle agentHistone deacetylase inhibitorsConventional chemotherapyResponse rateCentral RegisterPartial responsePTCL-NOSClinical trialsChemotherapy agentsComparable overall response ratesGeneric inverse variance methodCutaneous T-cell lymphomaPhase IParticular histological subtypeSpeakers bureauCochrane Central RegisterProgression-free survivalMature T-cell lymphomasPI3K/Akt/mTORDuration of responseInverse variance method
2018
Duvelisib, an oral dual PI3K‐δ, γ inhibitor, shows clinical activity in indolent non‐Hodgkin lymphoma in a phase 1 study
Flinn IW, Patel M, Oki Y, Horwitz S, Foss FF, Allen K, Douglas M, Stern H, Sweeney J, Kharidia J, Kelly P, Kelly VM, Kahl B. Duvelisib, an oral dual PI3K‐δ, γ inhibitor, shows clinical activity in indolent non‐Hodgkin lymphoma in a phase 1 study. American Journal Of Hematology 2018, 93: 1311-1317. PMID: 30033575, PMCID: PMC6220789, DOI: 10.1002/ajh.25228.Peer-Reviewed Original ResearchConceptsIndolent non-Hodgkin lymphomaDose-limiting toxicityNon-Hodgkin lymphomaClinical activityINHL patientsHematologic malignanciesClinical developmentGrade 3 transaminase elevationMedian progression-free survivalOral dual inhibitorAcute respiratory failureE. coli sepsisElevated liver enzymesOpen-label studyAcceptable safety profileAdvanced hematologic malignanciesDose-escalation phaseGrade 3 rashProgression-free survivalSevere adverse eventsPhase 1 studyDuration of responseFavorable clinical activityFurther clinical developmentBID cohort
2015
Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study
O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study. Journal Of Clinical Oncology 2015, 33: 2492-2499. PMID: 26101246, PMCID: PMC5087312, DOI: 10.1200/jco.2014.59.2782.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsInfusions, IntravenousKaplan-Meier EstimateLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalSulfonamidesTreatment OutcomeConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaInternational Working Group criteriaOverall response rateT-cell lymphomaPrior therapyOverall survivalGroup criteriaResponse rateEnd pointCommon grade 3Prior systemic therapyPrimary end pointSecondary end pointsNovel histone deacetylase inhibitorStem cell transplantationDuration of responseStandard of careDrug Administration approvalHistone deacetylase inhibitorsEvaluable patientsManageable toxicityAdverse eventsDurable responsesPartial response
2014
Romidepsin 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
Long‐term follow‐up and survival of cutaneous T‐cell lymphoma patients treated with extracorporeal photopheresis
Knobler R, Duvic M, Querfeld C, Straus D, Horwitz S, Zain J, Foss F, Kuzel T, Campbell K, Geskin L. Long‐term follow‐up and survival of cutaneous T‐cell lymphoma patients treated with extracorporeal photopheresis. Photodermatology Photoimmunology & Photomedicine 2012, 28: 250-257. PMID: 22971190, DOI: 10.1111/j.1600-0781.2012.00689.x.Peer-Reviewed Original ResearchConceptsDuration of responseOverall response rateExtracorporeal photopheresisOverall survivalSkin responseResponse rateImpact of ECPCutaneous T-cell lymphomaMedian overall survivalSurvival of patientsT-cell lymphomaLong-term treatmentECP initiationDurable responsesPivotal trialsPatientsCohortECP treatmentModern criteriaSurvivalTreatmentDiagnosisTrialsMonthsResponse
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