2024
Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML.
Gyurkocza B, Nath R, Seropian S, Choe H, Litzow M, Abboud C, Koshy N, Stiff P, Tomlinson B, Abhyankar S, Foran J, Hari P, Chen G, Al-Kadhimi Z, Kebriaei P, Sabloff M, Orozco J, Jamieson K, Silverman M, Van Besien K, Schuster M, Law A, Larkin K, Pandit-Taskar N, Rowley S, Munshi P, Cook R, Levy M, Lazarus H, Sandmaier B, Pagel J, Reddy V, MacDougall J, McNamara K, Spross J, Haeuber E, Vusirikala M, Nahar A, Desai A, Giralt S. Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML. Journal Of Clinical Oncology 2024, jco2302018. PMID: 39298738, DOI: 10.1200/jco.23.02018.Peer-Reviewed Original ResearchEvent-free survivalIntention-to-treat populationIntention-to-treatHazard ratioRR-AMLOverall survivalOlder patientsPhase III open-label trialEvent-free survival HRTreatment-related adverse eventsAllogeneic hematopoietic cell transplantationConventional careIncomplete platelet recoveryOS hazard ratioSecondary end pointsHematopoietic cell transplantationOpen-label trialConventional care groupPretransplant regimenRefractory AMLRelapsed/refractory AMLChemotherapy initiationDismal prognosisPlatelet recoveryCell transplantationLong-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. 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: s173. DOI: 10.1016/s2152-2650(24)00518-4.Peer-Reviewed Original ResearchAML-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
60 Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Older Patients with Active, Relapsed or Refractory (R/R) Acute Myeloid Leukemia Results in Successful and Timely Engraftment Not Related to the Radiation Dose Delivered
Gyurkocza B, Nath R, Choe H, Seropian S, Stiff P, Agura E, Abhyankar S, Litzow M, Tomlinson B, Abboud C, Chen G, Hari P, Orozco J, Sabloff M, Al-Kadhimi Z, Van Besien K, Silverman M, Foran J, Schuster M, Kebriaei P, Levy M, Lazarus H, Giralt S, Liang Q, Berger M, Reddy V, Pagel J. 60 Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Older Patients with Active, Relapsed or Refractory (R/R) Acute Myeloid Leukemia Results in Successful and Timely Engraftment Not Related to the Radiation Dose Delivered. Transplantation And Cellular Therapy 2021, 27: s57-s58. DOI: 10.1016/s2666-6367(21)00086-5.Peer-Reviewed Original Research
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 blastsAML-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