2023
131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML
Choe H, Tomlinson B, Gyurkocza B, Nath R, Seropian S, Litzow M, Abboud C, Stiff P, Abhyankar S, Foran J, Abedin S, Chen G, Al-Kadhimi Z, Kebriaei P, Sabloff M, Orozco J, Jamieson K, Magalhaes-Silverman M, Van Besien K, Schuster M, Law A, Mayer S, Lazarus H, Spross J, Li K, Haeuber E, Vusirikala M, Nahar A, Sandmaier B, Pagel J, Giralt S, Desai A, Koshy N. 131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML. Blood 2023, 142: 469. DOI: 10.1182/blood-2023-182177.Peer-Reviewed Original ResearchMedian overall survivalAllogeneic hematopoietic cell transplantDurable complete remissionHematopoietic cell transplantOverall survivalR AMLConventional careTP53 mutationsPositive ptsCC groupComplete remissionRelapse rateCell transplantHigh post-transplant relapse ratesInitiation of therapyPhase 3 studyTotal body irradiationHigh relapse rateCRP assessmentEvaluable ptsOlder ptsActive diseaseBaseline characteristicsRefractory AMLBody irradiation
2020
AML-123: Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Engraftment in Older Patients with Active, Relapsed, or Refractory (rel/ref) AML: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 SIERRA Trial
Gyurkocza B, Nath R, Stiff P, Agura E, Litzow M, Tomlinson B, Choe H, Abhyankar S, Seropian S, Chen G, Hari P, Al-Kadhimi Z, Foran J, Orozco J, Van Besien K, Sabloff M, Kebriaei P, Abboud C, Levy M, Lazarus H, Giralt S, Berger M, Reddy V, Pagel J. AML-123: Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Engraftment in Older Patients with Active, Relapsed, or Refractory (rel/ref) AML: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 SIERRA Trial. Clinical Lymphoma Myeloma & Leukemia 2020, 20: s182. DOI: 10.1016/s2152-2650(20)30716-3.Peer-Reviewed Original ResearchCC armOlder patientsTransplant ratesLower transplant-related mortalityIncidence of gradeNon-relapse mortalityTransplant-related mortalityMajority of patientsFavorable safety profileFebrile neutropeniaInduction therapyPrior therapyActive diseaseRefractory AMLSalvage therapyDurable responsesGraft failureInfusion reactionsEngraftment dataMedian ageSafety profilePatient populationAdvanced ageDisease progressionGrade 3Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Allogeneic Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial
Gyurkocza B, Nath R, Stiff P, Agura E, Litzow M, Tomlinson B, Choe H, Abhyankar S, Seropian S, Chen G, Hari P, Al-Kadhimi Z, Foran J, Orozco J, van Besien K, Sabloff M, Kebriaei P, Abboud C, Levy M, Lazarus H, Giralt S, Berger M, Reddy V, Pagel J. Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Allogeneic Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial. Transplantation And Cellular Therapy 2020, 26: s32-s33. DOI: 10.1016/j.bbmt.2019.12.575.Peer-Reviewed Original ResearchHematopoietic cell transplantationSalvage therapyOlder patientsCC armConventional careCC patientsConventional hematopoietic cell transplantationGrade 3 febrile neutropeniaAllogeneic hematopoietic cell transplantationPre-treated patientsPhase 3 trialFailure of chemotherapyYears of ageFebrile neutropeniaInduction therapyActive diseaseMyeloablative conditioningRefractory AMLBackground PatientsBM blastsInfusion reactionsMethods PatientsTransplant candidatesAllogeneic transplantationCurative therapy
2018
Targeted Conditioning of Iomab-B (131I-anti-CD45) Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Relapsed or Refractory Acute Myeloid Leukemia (AML): Preliminary Feasibility and Safety Results from the Prospective, Randomized Phase 3 Sierra Trial
Agura E, Gyurkocza B, Nath R, Litzow M, Tomlinson B, Abhyankar S, Seropian S, Stiff P, Choe H, Kebriaei P, Foran J, Chen G, Levy M, Lazarus H, Giralt S, Berger M, Reddy V, Pagel J. Targeted Conditioning of Iomab-B (131I-anti-CD45) Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Relapsed or Refractory Acute Myeloid Leukemia (AML): Preliminary Feasibility and Safety Results from the Prospective, Randomized Phase 3 Sierra Trial. Blood 2018, 132: 1017. DOI: 10.1182/blood-2018-99-111914.Peer-Reviewed Original ResearchHematopoietic cell transplantationAcute myeloid leukemiaR AMLRefractory acute myeloid leukemiaDurable complete remissionComplete remissionActive diseaseYears of ageSalvage therapyDonor chimerismCC armGrade 3Myeloid leukemiaDay 28Frequent non-hematologic adverse eventsNon-hematologic adverse eventsAllogeneic hematopoietic cell transplantationAdequate organ functionR AML patientsStandard induction therapyInfusion-related reactionsPrimary efficacy endpointBone marrow blastsTotal body irradiationOngoing multicenter trial