Actinium Pharmaceuticals(ATNM) Prnewswire·2025-03-17 12:50Core Insights - Actinium Pharmaceuticals has reported promising results from a clinical trial of Actimab-A in combination with CLAG-M for patients with relapsed or refractory acute myeloid leukemia (r/r AML), showing a median overall survival of 18.4 months [1][5] - The combination therapy demonstrated high rates of complete remissions and measurable residual disease negativity, particularly in high-risk patients, indicating its mutation agnostic potential [1][3] - Actinium plans to initiate a pivotal Phase 2/3 trial to further evaluate the efficacy of Actimab-A + CLAG-M in r/r AML patients [3][4] Clinical Trial Results - The trial showed a median overall survival of 18.4 months for patients who had received 1 or 2 lines of prior therapy, compared to historical data showing a median survival of 13.3 months with CLAG-M alone [5] - 52% of patients in the trial had TP53 mutations, and 75% of all patients achieved measurable residual disease negativity [5] - Among patients with prior Venetoclax therapy, 100% achieved measurable residual disease negativity, highlighting the effectiveness of the combination therapy [5] Future Developments - Actinium has aligned with the FDA to conduct a pivotal Phase 2/3 trial, which will include a randomized comparison of Actimab-A + CLAG-M versus CLAG-M alone [3][4] - The trial aims to optimize the dosing of Actimab-A and is expected to begin in 2025 [3] - Actinium is also engaged in a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute to explore additional combinations for AML treatment [6]