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 AML
2021
Clinical Experience in the Randomized Phase 3 Sierra Trial: Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Conditioning Enables Hematopoietic Cell Transplantation with Successful Engraftment and Acceptable Safety in Patients with Active, Relapsed/Refractory AML Not Responding to Targeted Therapies
Gyurkocza B, Nath R, Seropian S, Choe H, Litzow M, Koshy N, Stiff P, Abboud C, Tomlinson B, Abhyankar S, Hari P, Al-Kadhimi Z, Chen G, Sabloff M, Orozco J, Foran J, Kebriaei P, Jamieson K, Magalhaes-Silverman M, van Besien K, Schuster M, Law A, Levy M, Lazarus H, Giralt S, Berger M, Spross J, Desai A, Reddy V, Pagel J. Clinical Experience in the Randomized Phase 3 Sierra Trial: Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Conditioning Enables Hematopoietic Cell Transplantation with Successful Engraftment and Acceptable Safety in Patients with Active, Relapsed/Refractory AML Not Responding to Targeted Therapies. Blood 2021, 138: 1791. DOI: 10.1182/blood-2021-148497.Peer-Reviewed Original ResearchHematopoietic cell transplantAcute myeloid leukemiaR AMLAllogeneic hematopoietic cell transplantComplete remissionMedian radiation doseBristol-Myers SquibbCC patientsTargeted therapyFebrile neutropeniaFLT-3 inhibitorsCurrent equity holderSpeakers bureauConventional careMedian timeBcl-2 inhibitorsIDH inhibitorsRelapsed/Refractory Acute Myeloid LeukemiaIncidence of FNRefractory acute myeloid leukemiaAdvisory CommitteePrincipal investigatorSeattle GeneticsIncidence of gradeIncidence of sepsis
2020
High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia
Gyurkocza B, Nath R, Choe H, Seropian S, Stiff P, Abhyankar S, Agura E, Litzow M, Tomlinson B, Chen G, Hari P, Orozco J, Al-Kadhimi Z, Abboud C, Van Besien K, Sabloff M, Magalhaes-Silverman M, Foran J, Schuster M, Kebriaei P, Levy M, Lazarus H, Giralt S, Liang Q, Berger M, Reddy V, Pagel J. High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia. Blood 2020, 136: 30-31. DOI: 10.1182/blood-2020-134624.Peer-Reviewed Original ResearchHematopoietic cell transplantationAcute myeloid leukemiaCurrent equity holderR AMLFebrile neutropeniaTherapeutic doseGI tractBone marrowConventional careOlder patientsMyeloid leukemiaRefractory (R/R) AMLHigh-risk acute myeloid leukemiaLow-dose total body irradiationHigh dosesRadiation doseMyeloablative hematopoietic cell transplantationRefractory acute myeloid leukemiaAllogeneic hematopoietic cell transplantationAdvisory CommitteeAEs of interestIncidence of mucositisRate of mucositisInitiation of therapyMedian radiation dosePersonalized Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia Results in Successful Donor Hematopoietic Cells Engraftment with the Timing of Engraftment Not Related to the Radiation Dose Delivered
Gyurkocza B, Nath R, Choe H, Seropian S, Stiff P, Abhyankar S, Agura E, Litzow M, Tomlinson B, Chen G, Hari P, Orozco J, Al-Kadhimi Z, Abboud C, Van Besien K, Sabloff M, Magalhaes-Silverman M, Foran J, Schuster M, Kebriaei P, Levy M, Lazarus H, Giralt S, Liang Q, Berger M, Reddy V, Pagel J. Personalized Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia Results in Successful Donor Hematopoietic Cells Engraftment with the Timing of Engraftment Not Related to the Radiation Dose Delivered. Blood 2020, 136: 42-44. DOI: 10.1182/blood-2020-134948.Peer-Reviewed Original ResearchAllogeneic hematopoietic cell transplantationR AMLHematopoietic cell transplantationAcute myeloid leukemiaCurrent equity holderComplete remissionTherapeutic doseMarrow blastsOlder patientsCC patientsDelivery of radiationSalvage therapyPlatelet engraftmentRadiation doseRefractory (R/R) AMLHigh-risk acute myeloid leukemiaLow-dose total body irradiationDonor hematopoietic cell engraftmentAdvisory CommitteeSeattle GeneticsAdequate organ functionFull donor chimerismReduced intensity conditioningPhase 3 trialBone marrow blasts
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