SIERRA Trial Update on Novel Conditioning Regimen for Older Patients With AML
Posted: Monday, October 12, 2020
Preliminary results from a phase III analysis of data from the SIERRA trial suggest anti-CD45 iodine apamistamab (Iomab-B), a targeted condition treatment, followed by allogeneic hematopoietic cell transplantation, may be a beneficial option for older patients with active relapsed or refractory acute myeloid leukemia (AML). According to Boglarka Gyurkocza, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues, patients treated with Iomab-B seemed to achieve high transplantation rates and engraftment. The study findings were presented at the 2020 Society of Hematologic Oncology (SOHO) Annual Meeting (Abstract AML-123).
The research team randomly assigned 75 patients with relapsed or refractory AML to receive Iomab-B (n = 37) or conventional care (n = 38) to determine the safety and transplant rates in this mid-point analysis. Conventional care included a wide range of options according to the physician’s discretion. Patients who did not achieve complete responses in the conventional arm were offered to cross over to the Iomab-B arm.
Overall, 77% of the patients enrolled in the study underwent allogeneic hematopoietic cell transplantation. Of those patients, 84% were treated with Iomab-B, and 18% were treated with conventional care. All of the patients who received Iomab-B–based conditioning followed by transplantation achieved neutrophil and platelet engraftment. The research team did not observe any graft failures in the Iomab-B arm.
A higher percentage of patients treated with conventional care reported grade 3 febrile neutropenia than those treated with Iomab-B (46% vs. 23%). Generally, Iomab-B was reported to be well tolerated: a single patient had a grade 3 reaction, and there were no grade 4 reactions. None of the patients in the Iomab-B treatment group died, and the 100-day nonrelapse rate was 6%.
“The Iomab-B–based conditioning regimen has a favorable nonhematologic toxicity profile,” the researchers concluded.
Disclosure: No disclosure information for the study authors was provided.