2023
A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents
Bewersdorf J, Shallis R, Sharon E, Park S, Ramaswamy R, Roe C, Irish J, Caldwell A, Wei W, Yacoub A, Madanat Y, Zeidner J, Altman J, Odenike O, Yerrabothala S, Kovacsovics T, Podoltsev N, Halene S, Little R, Piekarz R, Gore S, Kim T, Zeidan A. A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents. Annals Of Hematology 2023, 103: 105-116. PMID: 38036712, DOI: 10.1007/s00277-023-05552-4.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityAcute myeloid leukemiaMarrow complete remissionPhase Ib trialAdverse eventsIb trialDose escalationNCI Cancer Therapy Evaluation ProgramAcute myeloid leukemia refractoryHematologic adverse eventsProtocol-defined responseDose level 1Anti-PD1 therapyAnti-PD1 antibodyDose-escalation designLimited clinical efficacySystems immunology approachHistone deacetylase inhibitor entinostatLeukemia refractoryMCR patientsComplete remissionRespiratory failureSuppressor cellsEscalation designClinical efficacy
2015
Azacitidine with or without Entinostat for the treatment of therapy‐related myeloid neoplasm: further results of the E1905 North American Leukemia Intergroup study
Prebet T, Sun Z, Ketterling RP, Zeidan A, Greenberg P, Herman J, Juckett M, Smith MR, Malick L, Paietta E, Czader M, Figueroa M, Gabrilove J, Erba HP, Tallman MS, Litzow M, Gore SD, intergroup T. Azacitidine with or without Entinostat for the treatment of therapy‐related myeloid neoplasm: further results of the E1905 North American Leukemia Intergroup study. British Journal Of Haematology 2015, 172: 384-391. PMID: 26577691, PMCID: PMC4794257, DOI: 10.1111/bjh.13832.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsAzacitidineBenzamidesDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesNeoplasms, Second PrimaryPyridinesTreatment OutcomeConceptsTherapy-related myeloid neoplasmsMyeloid neoplasmsDe novo MDS/AMLRandomized phase 2 studyCombination of azacitidineLeukemia intergroup studyMedian overall survivalPhase 2 studyMDS/AMLSerious late effectsHistone deacetylase inhibitor entinostatAZA monotherapyCombination armNormalization rateOverall survivalIntergroup studyTreatment of cancerPoor responseLate effectsMedian numberAzacitidinePatientsSingle agentResponse rateConventional treatment