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 rates131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant for Patients with TP53 Mutated R/R AML Results in Significantly Improved Outcomes
Foran J, Gyurkocza B, Nath R, Choe H, Litzow M, Abboud C, 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, Nagl N, Brodin P, Vusirikala M, Nahar A, Sandmaier B, Pagel J, Giralt S, Desai A, Seropian S. 131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant for Patients with TP53 Mutated R/R AML Results in Significantly Improved Outcomes. Transplantation And Cellular Therapy 2024, 30: s110-s111. DOI: 10.1016/j.jtct.2023.12.174.Peer-Reviewed Original ResearchHematopoietic cell transplantationAllogeneic hematopoietic cell transplantationTP53 mutationsMedian OSOverall survivalPositive PTCell transplantationCC groupDays post-hematopoietic cell transplantationControlled phase 3 studiesEradication of leukemic cellsPost-hematopoietic cell transplantationImprove outcomesConventional careMedian overall survivalTotal body irradiationPhase 3 studyOutcomes of PTPost hoc analysisR/R AMLBody irradiationAML patientsPrimary endpointCurative therapyRelapse rateDose-Response Demonstrated for Durable Complete Remission Following High-Dose Targeted Radiation with 131I-Apamistamab Prior to HCT in Patients with R/R AML
Chen G, Abboud C, Gyurkocza B, Nath R, Seropian S, Choe H, Litzow M, Koshy N, Stiff P, 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, Leung E, Chen M, Natwa M, Spross J, Li K, Desai A, Wahl R, Brodin P, Pandit-Taskar N. Dose-Response Demonstrated for Durable Complete Remission Following High-Dose Targeted Radiation with 131I-Apamistamab Prior to HCT in Patients with R/R AML. Transplantation And Cellular Therapy 2024, 30: s114-s115. DOI: 10.1016/j.jtct.2023.12.180.Peer-Reviewed Original ResearchPrimary endpointBone marrowLiver doseDose responseCurative allogeneic hematopoietic cell transplantationDose toleranceControlled phase 3 studiesEradication of leukemic cellsRate of hematologic toxicityAllogeneic hematopoietic cell transplantationConventional careTotal body irradiationPhase 3 studyHematopoietic cell transplantationRadiation dose toleranceDiseased bone marrowDoses to liverRadiation dose responseDose-response relationshipDose to target tissuesRadiation dose to liverAcute GVHDR/R AMLHematologic toxicityComplete remissionTargeted Myeloablative Radiation Using 131I-Apamistamab Prior to Allogeneic Hematopoietic Cell Transplant for Patients with R/R AML Results in Robust Engraftment
Choe H, Nath R, Seropian S, 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, Spross J, Li K, Nagl N, Vusirikala M, Nahar A, Desai A, Gyurkocza B. Targeted Myeloablative Radiation Using 131I-Apamistamab Prior to Allogeneic Hematopoietic Cell Transplant for Patients with R/R AML Results in Robust Engraftment. Transplantation And Cellular Therapy 2024, 30: s59-s60. DOI: 10.1016/j.jtct.2023.12.094.Peer-Reviewed Original ResearchHematopoietic cell transplantationAllogeneic hematopoietic cell transplantationTime to neutrophilCC armChronic GVHDDonor chimerismPlatelet engraftmentCell transplantationCumulative incidenceTherapeutic dosesCumulative incidence of grade III-IV acute graft-versus-host diseaseGrade III-IV acute graft-versus-host diseaseIII-IV acute graft-versus-host diseaseIncidence of grade III-IV acute graft-versus-host diseaseCumulative incidence of chronic GVHDCurative allogeneic hematopoietic cell transplantationDays post-hematopoietic cell transplantationAcute graft-versus-host diseaseControlled phase 3 studiesEradication of leukemic cellsGrade III-IV GvHDIncidence of chronic GVHDRadiation dose to marrowGraft-versus-host diseaseMedian time to neutrophil131I-Apamistamab Improves Outcomes in Patients 65 Years and Older with Relapsed or Refractory AML
Nath R, Seropian S, Gyurkocza B, Choe H, Litzow M, Abboud C, Koshy N, Stiff P, 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, Spross J, Li K, Nagl N, Vusirikala M, Nahar A, Desai A, Tomlinson B. 131I-Apamistamab Improves Outcomes in Patients 65 Years and Older with Relapsed or Refractory AML. Transplantation And Cellular Therapy 2024, 30: s54-s55. DOI: 10.1016/j.jtct.2023.12.089.Peer-Reviewed Original ResearchHematopoietic cell transplantationPrimary induction failureAcute myeloid leukemiaHigh-risk featuresNon-relapse mortalityCR/CRp ratesInduction failureCurative allogeneic hematopoietic cell transplantationAcute myeloid leukemia ptsAdverse cytogenetic risk groupControlled phase 3 studiesEradication of leukemic cellsRefractory acute myeloid leukemiaAllogeneic hematopoietic cell transplantationCC armCytogenetic risk groupMultiple high-risk featuresTotal body irradiationPhase 3 studyConventional careHigh-risk populationCompared to 0%BCL2 inhibitorsBody irradiationCell transplantation