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
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
2017
Duvelisib, a novel oral dual inhibitor of PI3K-δ,γ, is clinically active in advanced hematologic malignancies
Flinn IW, O'Brien S, Kahl B, Patel M, Oki Y, Foss FF, Porcu P, Jones J, Burger JA, Jain N, Kelly VM, Allen K, Douglas M, Sweeney J, Kelly P, Horwitz S. Duvelisib, a novel oral dual inhibitor of PI3K-δ,γ, is clinically active in advanced hematologic malignancies. Blood 2017, 131: 877-887. PMID: 29191916, PMCID: PMC6033052, DOI: 10.1182/blood-2017-05-786566.Peer-Reviewed Original ResearchConceptsT-cell lymphomaChronic lymphocytic leukemiaIndolent non-Hodgkin lymphomaOral dual inhibitorAdvanced hematologic malignanciesComplete responseTransaminase increaseHematologic malignanciesRefractory chronic lymphocytic leukemiaPeripheral T-cell lymphomaCutaneous T-cell lymphomaAlanine transaminase increaseHematologic malignancy treatmentDose-escalation phaseSevere adverse eventsPhase 1 studyDual inhibitorOverall response rateLate-stage clinical developmentNon-Hodgkin lymphomaCLL tumor cellsRange of dosesAdverse eventsClinical responseMedian time