Actinium Pharmaceuticals, Inc. announced that three abstracts detailing results from the completed Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) have been accepted for presentation at the 65(th) Annual American Society of Hematology Annual Meeting & Exposition (ASH) being held in San Diego on December 9-12, 2023. Outcomes of patients with a TP53 gene mutation enrolled in the SIERRA trial have been accepted for an oral presentation and results detailed in the abstract include the following: Medn OvOverall Survival (OS) of TP53 positive patients receiving Iob-B and a bone marrow transplant (BMT) w was 5.49 months compared to 1.66 months in patients who did not receive Iomab-B; Iomab-B produced a statistically significant improvement in median OS in TP53 positive patients with a hazard ratio of 0.23 and p-value of 0.0002; Median OS of 6.37 months in TP53 negative patients receiving Iomab-B and 5.72 months for TP53 positive patients demonstrating Iomab-B's mutation agnostic mechanism and ability to overcome TP53 gene mutations; 24% of patients (37/153) enrolled on the SIERRA trial had a TP53 mutation, with 17 being randomized to the Iomab-B arm and 20 randomized to the control arm.
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