Actinium’s Iomab-B is likely to address key unmet need in AML patient group after positive pivotal trial results, says GlobalData

Following the news that the Phase III pivotal SIERRA trial investigating Actinium’s targeted therapy Iomab-B (iodine i 131 apamistamab) in patients aged 55 years or older with relapsed or refractory acute myeloid leukemia (r/r AML), met its primary endpoint of durable complete remission (dCR) of 6 months post initial remission after a bone marrow transplant (BMT);

James Donagher, Oncology & Hematology Analyst at GlobalData, a leading data and analytics company, offers his view:

“These findings create an entirely new avenue for elderly patients with AML. Clinical studies have shown that AML patients who receive a BMT have increased overall survival rates compared to patients who receive chemotherapy alone. Furthermore, after the transplant procedure, most younger patients tend to go into complete remission after induction therapy whilst this success is not shared by elderly patients. These statistically significant results may give new therapeutic options to elderly patients with r/r AML who are not fit to receive intensive therapy.

“Iomab-B is a radioimmunoconjugate drug that can be used as a low-intensity conditioning regimen prior to transplant. Key opinion leaders (KOLs) believe that this drug can be successful in this patient group, but it would be dismissed by physicians where high-intensity conditioning regimens can be used, in other patient groups. Actinium Pharmaceuticals believes that its drug can disrupt the field of bone marrow conditioning in r/r AML.

“Given that Iomab-B aims to address the unmet need in AML that is improving outcomes after BMT in a small but well-defined patient population, this should accelerate the time-to-market for this drug. According to GlobalData’s consensus analyst forecasts, Iomab-B’s sales are expected to reach $99 million by 2028 in the US despite Actinium’s lack of commercial experience. The company intends to submit a biologics licence application (BLA) to the FDA seeking approval for the use of Iomab-B in this patient population, and to investigate this drug in other hematological diseases beyond AML.”