2023
Encouraging Efficacy Observed in Bexmab Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies
Kontro M, Stein A, Pyörälä M, Rimpiläinen J, Siitonen T, Hollmén M, Fjaellskog M, Pawlitzky I, Zeidan A, Daver N. Encouraging Efficacy Observed in Bexmab Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies. Blood 2023, 142: 2915. DOI: 10.1182/blood-2023-174912.Peer-Reviewed Original ResearchAcute myeloid leukemiaR AMLCLEVER-1Complete remissionStandard of careBex treatmentAdverse eventsBone marrow cellsHMA failureMarrow CRPatient BMPrior therapyPartial remissionAML patientsMedian numberT cellsDose levelsMyeloid malignanciesHigh-risk MDS patientsMarrow cellsMarrow complete remissionR AML patientsRisk MDS patientsNK cell numbersPhase 1/2 studyPhase 1/2 Study of the Pan-PIM Kinase Inhibitor INCB053914 Alone or in Combination With Standard-of-Care Agents in Patients With Advanced Hematologic Malignancies
Patel M, Donnellan W, Byrne M, Asch A, Zeidan A, Baer M, Fathi A, Kuykendall A, Zheng F, Walker C, Cheng L, Marando C, Savona M. Phase 1/2 Study of the Pan-PIM Kinase Inhibitor INCB053914 Alone or in Combination With Standard-of-Care Agents in Patients With Advanced Hematologic Malignancies. Clinical Lymphoma Myeloma & Leukemia 2023, 23: 674-686. PMID: 37290996, DOI: 10.1016/j.clml.2023.05.002.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsDose-limiting toxicityAdvanced hematologic malignanciesAcute myeloid leukemiaMyelodysplastic syndromeHematologic malignanciesCare agentsHigh-risk myelodysplastic syndromeMDS/myeloproliferative neoplasmPhase 1/2 studyEffective combination strategiesAdverse eventsComplete responseLymphoproliferative neoplasmsWeek 12Multiple myelomaSpleen volumeAcute leukemiaMyeloid leukemiaPreclinical modelsPatientsMyeloproliferative neoplasmsMoloney murine leukemia virus (PIM) kinasesMyelofibrosisKinase inhibitors
2022
A Phase 1/2 Study of the Oral Janus Kinase 1 Inhibitors INCB052793 and Itacitinib Alone or in Combination With Standard Therapies for Advanced Hematologic Malignancies
Zeidan AM, Cook RJ, Bordoni R, Berenson JR, Edenfield WJ, Mohan S, Zhou G, Asatiani E, Srinivas N, Savona MR. A Phase 1/2 Study of the Oral Janus Kinase 1 Inhibitors INCB052793 and Itacitinib Alone or in Combination With Standard Therapies for Advanced Hematologic Malignancies. Clinical Lymphoma Myeloma & Leukemia 2022, 22: 523-534. PMID: 35260349, DOI: 10.1016/j.clml.2022.01.012.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaPhase 1/2 studyAdvanced hematologic malignanciesMyelodysplastic syndromeHematologic malignanciesObjective responseStandard therapyRefractory acute myeloid leukemiaPhase 2 doseObjective response rateRefractory multiple myelomaPhase 2Lack of efficacyInhibition of JAK1Janus kinasePhase 1Primary endpointTreatment discontinuationAdverse eventsProgressive diseaseDose escalationStudy treatmentMultiple myelomaMyeloid leukemiaDNA methyltransferase inhibitor
2017
A Phase 1/2 Study of the Oral Novel JAK1 Inhibitor INCB052793 As Monotherapy and in Combination with Standard Therapies in Patients with Advanced Hematologic Malignancies
Zeidan A, Cook R, Bordoni R, Asatiani E, Zhou G, Faivre T, Byrne M, Savona M. A Phase 1/2 Study of the Oral Novel JAK1 Inhibitor INCB052793 As Monotherapy and in Combination with Standard Therapies in Patients with Advanced Hematologic Malignancies. Blood 2017, 130: 640. DOI: 10.1182/blood.v130.suppl_1.640.640.Peer-Reviewed Original ResearchAdvanced acute myeloid leukemiaMDS/MPNAdvanced hematologic malignanciesOverall response rateHigh-risk myelodysplastic syndromePhase 1/2 studyComplete responseIncyte CorporationMyelodysplastic syndromeCombination therapyMultiple myelomaHematologic malignanciesData cutoffAdverse eventsStandard therapySpeakers bureauJAK/STAT pathwayPreliminary safetyDisease progressionEfficacy dataMorphologic leukemia-free stateOngoing phase 1/2 studyJAK1 inhibitorAdvisory CommitteeAdvanced myeloid malignancies