2024
AML-545 Long-Term Follow-up Demonstrates Ongoing Efficacy Benefit of 131I-Apamistamab-led Allogeneic Hematopoietic Cell Transplantation in Older Patients With Active, R/R AML in the Phase 3 SIERRA Trial
Seropian S, Gyurkocza B, Nath R, Choe H, Litzow M, Abboud C, Koshy N, Stiff P, Tomlinson B, Abhyankar S, Foran J, Abedin S, Chen G, Al-Kadhimi Z, Kebriaei P, Sabloff M, Orozco J, Jamieson K, Silverman M, Van Besien K, Schuster M, Law A, Mayer S, Lazarus H, Spross J, Li K, Vusirikala M, Sandmaier B, Pagel J, Desai A, Giralt S. AML-545 Long-Term Follow-up Demonstrates Ongoing Efficacy Benefit of 131I-Apamistamab-led Allogeneic Hematopoietic Cell Transplantation in Older Patients With Active, R/R AML in the Phase 3 SIERRA Trial. Clinical Lymphoma Myeloma & Leukemia 2024, 24: s319. DOI: 10.1016/s2152-2650(24)01210-2.Peer-Reviewed Original ResearchAllogeneic hematopoietic cell transplantationR/R AMLHematopoietic cell transplantationFollow-upOverall survivalCell transplantationCC patientsCurative allogeneic hematopoietic cell transplantationOlder patientsControlled phase 3 studiesRefractory acute myeloid leukemiaConventional careMedian overall survivalR/R AML patientsMedian follow-upTotal body irradiationBaseline patient characteristicsAcute myeloid leukemiaAnalysis of efficacyOff-target toxicityLong-term survivorsCD45-expressing cellsData cutoffBody irradiationMucositis rates
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
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
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 blastsTargeted 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
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