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 irradiationHigh-Dose Targeted Radiation with 131I-Apamistamab Prior to HCT Demonstrated a Dose-Response for Durable Complete Remission in Patients with R/R AML
Litzow M, Chen G, Gyurkocza B, Nath R, Seropian S, Choe H, Abboud C, Koshy N, Tomlinson B, Abhyankar S, Foran J, Abedin S, 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, Leung E, Chen M, Natwa M, Spross J, Li K, Nagl N, Haeuber E, Vusirikala M, Nahar A, Sandmaier B, Pagel J, Giralt S, Desai A, Wahl R, Pandit-Taskar N, Brodin P, Stiff P. High-Dose Targeted Radiation with 131I-Apamistamab Prior to HCT Demonstrated a Dose-Response for Durable Complete Remission in Patients with R/R AML. Blood 2023, 142: 3529. DOI: 10.1182/blood-2023-189040.Peer-Reviewed Original ResearchDurable complete remissionConventional careLiver dosePrimary endpointBone marrowR AMLComplete remissionLiver ratioHigh doseLeukemic cellsRadiation doseAllogeneic hematopoietic cell transplantRadiation dose-response relationshipHematopoietic cell transplantMost older patientsPhase 3 studyTotal body irradiationFavorable biodistributionRadiation dose toleranceYears of ageDose toleranceDose-response relationshipDiseased bone marrowMedian doseRefractory AML131I-Apamistamab Effectively Achieved Durable Responses in Patients with R/R AML Irrespective of the Presence of Multiple High-Risk Factors
Seropian S, Foran J, Gyurkocza B, Nath R, Choe H, Litzow M, Koshy N, Stiff P, Tomlinson B, Abhyankar S, 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, Abboud C. 131I-Apamistamab Effectively Achieved Durable Responses in Patients with R/R AML Irrespective of the Presence of Multiple High-Risk Factors. Blood 2023, 142: 2159. DOI: 10.1182/blood-2023-187433.Peer-Reviewed Original ResearchDurable complete remissionAdverse-risk cytogeneticsMultiple risk factorsRisk factorsConventional careCC groupComorbidity indexComplete remissionDurable responsesAllogeneic hematopoietic cell transplantHigh transplant-related mortalityMultiple high-risk factorsPrimary induction failureTransplant-related mortalityHematopoietic cell transplantInitiation of therapyMost older patientsPhase 3 studyHigher comorbidity indexTotal body irradiationHigh-risk factorsMechanism of actionAML ptsCRP assessmentEvaluable pts
2019
Re-Induction and Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of 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, Levy M, Lazarus H, Giralt S, Berger M, Reddy V, Pagel J. Re-Induction and Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of 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. Blood 2019, 134: 5642. DOI: 10.1182/blood-2019-122776.Peer-Reviewed Original ResearchHematopoietic cell transplantationComplete remissionSalvage therapyCC armJazz PharmaceuticalsSpeakers bureauEligible patientsFebrile neutropeniaBM blastsConventional careCC patientsPatient populationGrade 3 febrile neutropeniaGrade 3 infusion reactionsPre-treated patient populationAllogeneic hematopoietic cell transplantationAdvisory CommitteeSeattle GeneticsAdequate organ functionDurable complete remissionPre-treated patientsPhase 3 trialProportion of patientsReduced intensity conditioningLack of efficacy
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