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
2020
The Integration of PD1 blockade with epigenetic therapy is highly active and safe in heavily treated patients with T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
Marchi E, Ma H, Montanari F, Sawas A, Lue J, Deng C, Whitfield K, Klein S, Scotto L, Jain S, Lister J, Benanni N, Francescone M, Kim W, Zinzani P, O'Connor O. The Integration of PD1 blockade with epigenetic therapy is highly active and safe in heavily treated patients with T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). Journal Of Clinical Oncology 2020, 38: 8049-8049. DOI: 10.1200/jco.2020.38.15_suppl.8049.Peer-Reviewed Original ResearchCutaneous T-cell lymphomaT-cell lymphomaGrade 3 hyponatremiaPhase 1b studyTreatment-related deathsGrade 3 thrombocytopeniaImmune checkpoint inhibitorsPreliminary clinical dataDose of drugPre-clinical modelsCancer-testis antigensCases of toxicityExperienced progressionFebrile neutropeniaRefractory PTCLStable diseaseComplete remissionPartial remissionPatient characteristicsClinical dataPharmacodynamic studiesTestis antigensPatientsTriple combinationResponse 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 modifiersPatients
2018
Combined Hypomethylating Agents (HMA) and Histone Deacetylase Inhibitors (HDACi) Exhibit Compelling Activity in Patients with Peripheral T-Cell Lymphoma (PTCL) with High Complete Response Rates in Angioimmunoblastic T-Cell Lymphoma (AITL)
Falchi L, Lue J, Montanari F, Marchi E, Amengual J, Sawas A, Deng C, Khan K, Kim H, Atkins L, Rada A, Serge C, O'Connor O. Combined Hypomethylating Agents (HMA) and Histone Deacetylase Inhibitors (HDACi) Exhibit Compelling Activity in Patients with Peripheral T-Cell Lymphoma (PTCL) with High Complete Response Rates in Angioimmunoblastic T-Cell Lymphoma (AITL). Blood 2018, 132: 1002. DOI: 10.1182/blood-2018-99-116605.Peer-Reviewed Original ResearchPeripheral T-cell lymphomaAngioimmunoblastic T-cell lymphomaT-cell lymphomaDuration of responseAdverse eventsHypomethylating agentR Peripheral T Cell LymphomaResponse rateMedian DORHigh complete response ratePhase 2Dose-escalation portionG1-2 toxicitiesNausea/vomitingPhase 1 patientsPhase 2 doseComplete response ratePhase 1/2 trialProgression-free survivalOverall response rateTreatment-naïve individualsNon-T-cell lymphomasCancer-testis antigensB-cell lymphomaCombination of AZAProlonged Overall Survival (OS) in a Subset of Responders to the Combination of Brentuximab Vedotin (Bv) and Bendamustine (B) in Heavily Treated Patients with Relapsed or Refractory Hodgkin Lymphoma (HL): Results of an International Multi- Center Phase I/II Experience
Sawas A, Kuruvilla J, Lue J, Deng C, Amengual J, Montanari F, Savage K, Elgedawe H, Villa D, Crump M, Connors J, O'Connor O. Prolonged Overall Survival (OS) in a Subset of Responders to the Combination of Brentuximab Vedotin (Bv) and Bendamustine (B) in Heavily Treated Patients with Relapsed or Refractory Hodgkin Lymphoma (HL): Results of an International Multi- Center Phase I/II Experience. Blood 2018, 132: 2907. DOI: 10.1182/blood-2018-99-117251.Peer-Reviewed Original ResearchAutologous stem cell transplantProgression-free survivalRefractory Hodgkin lymphomaComplete response rateDose limiting toxicitiesHigh-dose chemotherapyOverall response rateHodgkin's lymphomaBrentuximab vedotinOverall survivalDay 1Partial responseMedian numberDose levelsPrior autologous stem cell transplantResponse rateAutologous stem cell transplantationSeattle GeneticsPhase II dosePhysician's choice chemotherapyPrior radiation therapyPrior systemic therapyLong-term respondersSubset of patientsEvidence of relapse