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 age
2021
A Global Phase 2 Study of Valemetostat Tosylate (Valemetostat) in Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL), Including R/R Adult T-Cell Leukemia/Lymphoma (ATL) - Valentine-PTCL01
Foss F, Porcu P, Horwitz S, Izutsu K, Ishitsuka K, Kato K, Jin J, Du Y, Inoue A. A Global Phase 2 Study of Valemetostat Tosylate (Valemetostat) in Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL), Including R/R Adult T-Cell Leukemia/Lymphoma (ATL) - Valentine-PTCL01. Blood 2021, 138: 2533. DOI: 10.1182/blood-2021-144676.Peer-Reviewed Original ResearchR Peripheral T Cell LymphomaTreatment-emergent adverse eventsPeripheral T-cell lymphomaALK-positive anaplastic large cell lymphomaT-cell lymphomaNon-Hodgkin lymphomaPhase 2 studyOverall response rateKyowa Hakko KirinPersonal feesCohort 1Current equity holderDaiichi SankyoResponse rateSeattle GeneticsOno PharmaceuticalCohort 2Computed tomographyMonomorphic epitheliotropic intestinal T-cell lymphomaActive central nervous system (CNS) involvementADC therapeuticsSerious treatment-emergent adverse eventsRefractory peripheral T-cell lymphomaNodal peripheral T-cell lymphomaAllogeneic hematopoietic cell transplantEfficacy 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 countVorinostat
2015
Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma
Duvic M, Pinter-Brown LC, Foss FM, Sokol L, Jorgensen JL, Challagundla P, Dwyer KM, Zhang X, Kurman MR, Ballerini R, Liu L, Kim YH. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma. Blood 2015, 125: 1883-1889. PMID: 25605368, PMCID: PMC4375715, DOI: 10.1182/blood-2014-09-600924.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaEfficacy of mogamulizumabT-cell lymphomaAnti-CC chemokine receptor 4 monoclonal antibodyFrequent treatment-emergent adverse eventsCutaneous T-cell lymphoma patientsTreatment-emergent adverse eventsT-cell lymphoma patientsSignificant hematologic effectsInfusion-related reactionsPhase 1/2 studyOverall response ratePhase 3 investigationAnti-CCR4 antibodyEvaluable patientsBlood involvementAdverse eventsGrade 1/2Sézary syndromeComplete responseMycosis fungoidesLymphoma patientsHematologic effectsDisease progressionMogamulizumab