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Actinium : Iomab-B Phase 3 Trial Results Show Significant Survival Benefit In High-Risk AML Patients

Actinium Pharmaceuticals Inc. (ATNM) said that median overall survival of 5.49 months observed in patients with a TP53 mutation receiving an Iomab-B led allogeneic bone marrow transplant compared to 1.66 months in patients that did not receive Iomab-B in the Phase 3 SIERRA Trial.

The company noted that long-term efficacy results in older patients with active relapsed or refractory acute myeloid leukemia also observed in the SIERRA trial.

ATNM closed Tuesday's regular trading at $9.89 up $1.03 or 11.63%. In the after-hours trading the stock further gained $0.73 or 7.38%.

Actinium stated that the results from the Phase 3 SIERRA trial of Iomab-B have been accepted for an oral presentation and poster presentation at the 2024 European Hematology Association (EHA) Hybrid Congress being held June 13 - 16, 2024, in Madrid, Spain.

The Phase 3 SIERRA trial enrolled 153 patients ages 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) and compared outcomes of patients receiving an Iomab-B led bone marrow transplant (BMT) to those of patients receiving physician's choice of care in the control arm.

Across all patients in SIERRA study, only patients receiving an Iomab-B led BMT achieved the trial's primary endpoint of durable complete remission with these patients having 92% 1-year survival and 69% 2-year survival with statistically significant higher event free survival.

The SIERRA trial enrolled high-risk patients including those with one or more of the following: a TP53 mutation, advanced age up to 77 years old, complex cytogenetics and prior therapy including venetoclax and other targeted agents.

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