Actinium Pharmaceuticals has reported data from the Phase III SIERRA clinical trial of Iomab-B (Iodine-131-apamistamab) to treat patients with relapsed or refractory acute myeloid leukaemia (r/r AML).

The randomised, multicentre, controlled trial enrolled 153 people aged 55 years and above with r/r AML and those who were heavily pre-treated and had high-risk characteristics such as a TP53 mutation.

It compared the outcomes of those receiving Iomab-B and a bone marrow transplant (BMT) compared to those who received physician's choice of salvage chemotherapy and standard allogeneic BMT in the control arm.

According to the findings, the trial met its primary endpoint of durable Complete Remission (dCR) and showed a significant improvement in Event Free Survival (EFS).

The trial achieved a 22% dCR rate in the Iomab-B arm compared to 0% in the control arm.

This result was statistically significant and highlighted the potential of Iomab-B in inducing remission in patients with r/r AML.

However, the SIERRA trial did not meet the secondary endpoint of overall survival (OS) on an intent to treat basis analysis. This was attributed to the high crossover rate, with nearly 60% of control arm patients eventually receiving Iomab-B followed by a BMT.

Supplemental analyses of the SIERRA trial data indicated improved survival outcomes, particularly in patients with a TP53 mutation and increased one- and two-year overall survival rates in patients aged 65 and above.

Actinium chairman and CEO Sandesh Seth said: “We believe the SIERRA trial was a major advancement for the field of BMT and targeted radiotherapeutics but most importantly for patients with relapsed and refractory AML.

“We look forward to completing our interactions with the FDA to finalise the specifics of the additional Phase III randomised trial and working to secure a US partner for Iomab-B. In doing so, we hope to accelerate Iomab-B reaching patients with high unmet need that can benefit from a bone marrow transplant.”

"Actinium Pharmaceuticals reports data from Phase III trial of AML treatment" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.

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