Actinium says ‘positive’ pivotal Phase 3 SIERRA trial results presented at EBMT

Actinium Pharmaceuticals announced that the "positive" results from the pivotal Phase 3 SIERRA Trial of Iomab-B were presented in an oral presentation at the European Society for Blood and Marrow Transplantation, or EBMT, 49th Annual Meeting that was held in Paris, France April 23-26. "The SIERRA trial is the first randomized Phase 3 trial to take unfit, transplant ineligible patients with active relapsed or refractory acute myeloid leukemia age 55 and above to bone marrow transplant, which was feasible due to Iomab-B’s novel targeted radiotherapy approach that allows patients to receive a BMT without achieving a Complete Remission," the company stated. "As previously presented 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 in February 2023, Iomab-B enabled unprecedented 100% access to BMT in half the time, 29 days vs. 66.5 days, with 100% of Iomab-B patients achieving engraftment, the first sign of BMT success. Iomab-B met the study’s primary endpoint of dCR of 6-months following initial complete remission after BMT with high statistical significance with only patients receiving Iomab-B achieving dCR. The Iomab-B patients achieving dCR had a 92% 1-year survival rate and a 60% 2-year survival rate, which represents a potential cure, and median overall survival has not been reached in the patients achieving dCR," the company added.