Dr. Nath on the Interim Results of the SIERRA Trial in Relapsed/Refractory AML

Rajneesh Nath, MD, hematologist/oncologist, Banner Health, discusses the interim results of the phase 3 SIERRA trial in patients with relapsed/refractory acute myeloid leukemia (AML).

The ongoing SIERRA trial (NCT02665065) randomized patients 1:1 to receive a conditioning regimen comprised of targeted radiation with Iomab-B plus hematopoietic stem cell transplant or conventional care. Interim results from the study, which were presented during the 2021 Transplantation and Cellular Therapy Meetings, showed that 4.2% of patients became septic on the Iomab-B regimen vs 30% on standard therapy vs 23.3% who crossed over to the Iomab-B regimen from the standard regimen.

The hypothesis that powered the study suggested that utilizing a myeloablative, targeted conditioning therapy would mitigate toxicities, particularly within the gastrointestinal tract, explains Nash. In turn, patients would have less mucositis, febrile neutropenia, and sepsis. Although only 75% of the total estimated patient population were included, the findings are statistically significant and clinically meaningful, concludes Nash.