Abstract
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 and leukemia, Vol.24(Supplement 1), pp.S319-S319
09/2024
DOI: 10.1016/S2152-2650(24)01210-2
Abstract
Most older patients with relapsed or refractory acute myeloid leukemia (R/R AML) are ineligible for curative allogeneic hematopoietic cell transplant (alloHCT) due to intolerance to intensive therapies. Iomab-B (131I-apamistamab) delivers high-dose targeted radiation to CD45-expressing cells, producing antileukemic effect and myeloablation while limiting off-target toxicity. In SIERRA, Iomab-B-led alloHCT improved outcomes in active R/R AML patients (shown at June 2022 data cutoff). We report a subsequent analysis of efficacy after longer follow-up (as of January 2024).
SIERRA (NCT02665065) was a multicenter, randomized, controlled phase 3 study of Iomab-B-led alloHCT compared with the physician's choice of conventional care (CC) in patients ≥55 years with active, R/R AML. Patients were randomized (1:1, N=153) to CC or Iomab-B with fludarabine and total body irradiation (2 Gy) followed by alloHCT (CC, n=77; Iomab-B, n=76). Primary endpoint was durable CR (dCR), defined as a remission lasting ≥180 days from initial CR/CRp.
Baseline patient characteristics were balanced between arms. All 66 patients who received a therapeutic dose of Iomab-B underwent alloHCT vs 14 CC patients (18.2%). Of evaluable patients (Iomab-B: 59; CC: 64), 44 (74.6%) Iomab-B pts achieved initial CR/CRp versus 4 (6.3%) CC patients; dCR rates were 22% vs 0% (95% CI, 12.29-34.73; P<0.0001), respectively. Median follow-up was 36.6 mos (95% CI, 24.8-49.4) and 43.6 mos (95% CI, 35.1-60.9) at primary and subsequent cutoffs. Median overall survival (OS) was 6.3 mos (95% CI, 5.1-7.9) for Iomab-B and 4.0 months (95% CI, 3.0-5.1) for CC pts (HR 0.69 [95% CI, 0.49-0.97]; P=0.0314) at the January 2024 data cutoff. Of the 13 dCR patients in the Iomab-B arm, 92.3% were alive at 12 mos and 69.2% at 24 mos. Iomab-B was well tolerated, with lower sepsis and mucositis rates than standard alloHCT patients.
The primary endpoint of dCR was improved in patients ≥55 y with active R/R AML receiving Iomab-B-led alloHCT versus CC. Most patients achieving dCR are long-term survivors. Improved outcomes in Iomab-B-treated patients persisted at longer follow-up. The Iomab-B-led regimen was well-tolerated and provided access to potentially curative alloHCT in a patient population traditionally considered ineligible for transplant.
Details
- Title: Subtitle
- 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
- Creators
- Stuart Seropian - Yale UniversityBoglarka Gyurkocza - Memorial Sloan Kettering Cancer CenterRajneesh Nath - Banner MD Anderson Cancer CenterHannah Choe - The Ohio State UniversityMark Litzow - Mayo ClinicCamille Abboud - Washington University in St. Louis School of MedicineNebu Koshy - Baylor University Medical CenterPatrick Stiff - Loyola University Medical CenterBenjamin Tomlinson - University Hospitals of ClevelandSunil Abhyankar - The University of Kansas Cancer CenterJames Foran - Mayo ClinicSameem Abedin - Medical College of WisconsinGeorge Chen - The University of Texas MD Anderson Cancer CenterZaid Al-Kadhimi - University of AlabamaPartow Kebriaei - The University of Texas MD Anderson Cancer CenterMitchell Sabloff - University of OttawaJohnnie Orozco - University of Washington School of MedicineKatarzyna Jamieson - University of North Carolina at Chapel HillMargarida Silverman - University of IowaMichael Schuster - Stony Brook UniversityKoen Van Besien - University Hospitals of ClevelandArjun Law - Princess Margaret Cancer CentreSebastian Mayer - Weill Cornell MedicineHillard Lazarus - Case Western Reserve UniversityJennifer Spross - Actinium PharmaceuticalsKate Li - Actinium PharmaceuticalsMadhuri Vusirikala - Actinium PharmaceuticalsBrenda Sandmaier - University of Washington School of MedicineJohn Pagel - Loxo Oncology at LillyAvinash Desai - Actinium PharmaceuticalsSergio Giralt - Memorial Sloan Kettering Cancer Center
- Resource Type
- Abstract
- Publication Details
- Clinical lymphoma, myeloma and leukemia, Vol.24(Supplement 1), pp.S319-S319
- Publisher
- Elsevier Inc
- DOI
- 10.1016/S2152-2650(24)01210-2
- ISSN
- 2152-2650
- Language
- English
- Date published
- 09/2024
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984701245102771
Metrics
2 Record Views