2021
Combined oral 5-azacytidine and romidepsin are highly effective in patients with PTCL: a multicenter phase 2 study
Falchi L, Ma H, Klein S, Lue JK, Montanari F, Marchi E, Deng C, Kim HA, Rada A, Jacob AT, Kinahan C, Francescone MM, Soderquist CR, Park DC, Bhagat G, Nandakumar R, Menezes D, Scotto L, Sokol L, Shustov AR, O’Connor O. Combined oral 5-azacytidine and romidepsin are highly effective in patients with PTCL: a multicenter phase 2 study. Blood 2021, 137: 2161-2170. PMID: 33171487, DOI: 10.1182/blood.2020009004.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaOverall response rateMedian progression-free survivalProgression-free survivalT-cell lymphomaOverall survivalR Peripheral T Cell LymphomaResponse rateFollicular helper cell phenotypeMulticenter phase 2 studyHigher overall response rateFrequent grade 3Complete response rateComplete remission ratePhase 2 studyPhase 1 trialDuration of responseHelper cell phenotypeLonger median survivalHistone deacetylase inhibitorsPTCL patientsR diseaseTreatment-naïveMedian survivalRemission rate
2019
Oral 5-azacytidine and romidepsin exhibit marked activity in patients with PTCL: a multicenter phase 1 study
O’Connor O, Falchi L, Lue JK, Marchi E, Kinahan C, Sawas A, Deng C, Montanari F, Amengual JE, Kim HA, Rada AM, Khan K, Jacob AT, Malanga M, Francescone MM, Nandakumar R, Soderquist CR, Park DC, Bhagat G, Cheng B, Risueño A, Menezes D, Shustov AR, Sokol L, Scotto L. Oral 5-azacytidine and romidepsin exhibit marked activity in patients with PTCL: a multicenter phase 1 study. Blood 2019, 134: 1395-1405. PMID: 31471376, DOI: 10.1182/blood.2019001285.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaPhase 1 studyDay 1Day 8Response rateMulticenter phase 1 studyT-cell lymphoma patientsAdvanced lymphoid malignanciesTreatment-related deathsComplete response rateCoprimary end pointsGrade 3 thrombocytopeniaGrade 4 neutropeniaGrade 4 thrombocytopeniaOverall response rateT-cell lymphomaNon-T-cell lymphomasTumor mutational profileHistone deacetylase inhibitorsPTCL patientsPleural effusionLymphoma patientsLymphoid malignanciesEpigenetic modifiersPatientsEffect of epigenetic modifier-based combinations on efficacy in patients with peripheral T-cell lymphoma (PTCL): Deciphering impact of mutations in epigenetic operations on response.
O'Connor O, Sokol L, Shustov A, Falchi L, Lue J, Montanari F, Amengual J, Sawas A, Deng C, Khan K, Jacobs A, Rada A, Kim H, Soderquist C, Park D, Menezes D. Effect of epigenetic modifier-based combinations on efficacy in patients with peripheral T-cell lymphoma (PTCL): Deciphering impact of mutations in epigenetic operations on response. Journal Of Clinical Oncology 2019, 37: 7565-7565. DOI: 10.1200/jco.2019.37.15_suppl.7565.Peer-Reviewed Original ResearchPeripheral T-cell lymphomaHistone deacetylase inhibitorsPTCL patientsNext-generation sequencingTET2 mutationsPhase 2 studyMajority of patientsPhase 1 studyTreatment-naïve individualsT-cell lymphomaLikelihood of responseClinical trial scenariosR lymphomaTCL patientsExploratory endpointsPreclinical dataEfficacy dataHypomethylating agentR StudyPatientsDeacetylase inhibitorsClinical metricsMarked activityLymphomaEpigenetic drugs