Actinium Pharmaceuticals announces ‘positive’ phase 3 SIERRA trial data in AML

The company states: "Actinium Pharmaceuticals announced positive results for the primary and secondary endpoints from its pivotal Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia, or r/r AML. Iomab-B met the primary endpoint of durable Complete Remission of 6-months following initial complete remission following BMT with a high degree of statistical significance. Additionally, Iomab-B produced a significant and clinically meaningful improvement in the secondary endpoint of Event-Free Survival, with a 78% reduction in the probability of an event. Iomab-B doubled 1-year survival compared to the control arm excluding cross over patients as well as median overall survival. 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. 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 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 and the Center for International Blood & Marrow Transplant Research."