Positive full data results from the pivotal phase III SIERRA trial of Iomab-B in patients with active, relapsed or refractory acute myeloid leukemia.- Actinium Pharmaceuticals,
Actinium Pharmaceuticals, Inc., announced positive results for the primary and secondary endpoints from its pivotal Phase III SIERRA trial. Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6-months following initial complete remission following BMT with a high degree of statistical significance (p<0.0001).></0.0001).>
Additionally, Iomab-B produced a significant and clinically meaningful improvement in the secondary endpoint of Event-Free Survival (EFS), with a 78% reduction in the probability of an event (Hazard Ratio=0.22, p<0.0001).></0.0001).>
Iomab-B doubled 1-year survival compared to the control arm excluding cross over patients (26.1% vs 13.1%) as well as median overall survival (6.4 months vs. 3.2 months).
Iomab-B was well tolerated with four times lower rates of sepsis (6.1% vs 28.6%) and lower rates of febrile neutropenia, mucositis and acute graph versus host disease (aGVHD). Iomab-B enabled unprecedented access to BMT with 100% engraftment in patients receiving a therapeutic dose of Iomab-B compared to 18% of patients in the control arm and Iomab-B produced a 75% post-BMT Complete Remission (CR) rate compared to 6.3% post-BMT CR in the control arm. These high rates of access and post-BMT CR enabled the highly significant primary endpoint results.
The full SIERRA results were presented in the late-breaker session at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).
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