Actinium Announces Oral Presentation Detailing Improved Survival Outcomes in TP53 Positive Patients at the EHA 2024 Annual Congress and Presentation of Long-Term Efficacy Results in Older Patients Receiving an Iomab-B Led Bone Marrow Transplant in the Phase 3 SIERRA Trial

Rhea-AI Summary

Actinium Pharmaceuticals announced that the Phase 3 SIERRA trial results of Iomab-B will be presented at the EHA 2024 Congress. The trial demonstrated significant survival benefits in older patients with relapsed or refractory acute myeloid leukemia (r/r AML) receiving an Iomab-B led bone marrow transplant (BMT). Patients with TP53 mutations saw a median overall survival of 5.49 months compared to 1.66 months for those not receiving Iomab-B. The trial enrolled high-risk patients and showed 92% 1-year survival and 69% 2-year survival rates in those receiving Iomab-B led BMT.

Positive

• Median overall survival of 5.49 months in TP53 mutation patients receiving Iomab-B led BMT compared to 1.66 months without it.
• Phase 3 SIERRA trial showed 92% 1-year survival and 69% 2-year survival for Iomab-B led BMT patients.
• Statistically significant higher event-free survival in Iomab-B led BMT patients.
• Iomab-B results to be presented at the high-profile EHA 2024 Congress.
• Trial included high-risk patients, enhancing the reliability of results.

Negative

• Patients with TP53 mutations still have a median overall survival of only 5.49 months with Iomab-B.
• No significant improvements reported for patients without TP53 mutations.
• treatment options and poor outcomes still persist for a significant proportion of patients.
• Potential high costs and accessibility issues for the Iomab-B treatment.

- 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 (hazard ratio=0.23, p=0.0002) in the Phase 3 SIERRA Trial

- Long-term efficacy results in older patients with active relapsed or refractory acute myeloid leukemia also observed in the SIERRA trial

NEW YORK, May 14, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today announced that 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.

In total, 24% (37/153) of the patients enrolled on SIERRA had a TP53 mutation, which is usually associated with limited treatment options and poor outcomes. 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 (hazard ratio=0.23, p=0.0002).

Iomab-B EHA presentations titles are as follows:

Oral Presentation

131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT RESULTS IN IMPROVED SURVIVAL OUTCOMES IN R/R AML PATIENTS WITH HIGH-RISK TP53 MUTATIONS IN THE RANDOMIZED PHASE III SIERRA TRIAL

Poster Presentation

LONG TERM EFFICACY RESULTS OF THE SIERRA TRIAL: A PHASE 3 STUDY OF 131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION VERSUS CONVENTIONAL CARE IN OLDER PATIENTS WITH ACTIVE, R/R AML

About Actinium Pharmaceuticals, Inc.

Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B (pre-BLA & MAA (EU)), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes. Actinium holds more than 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron.

For more information, please visit: https://www.actiniumpharma.com/

Forward-Looking Statements

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Investors:
investorrelations@actiniumpharma.com 

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SOURCE Actinium Pharmaceuticals, Inc.

FAQ

What are the survival outcomes for TP53 positive patients receiving Iomab-B in the SIERRA trial?

Patients with a TP53 mutation had a median overall survival of 5.49 months compared to 1.66 months for those not receiving Iomab-B.

What were the long-term survival rates for Iomab-B led BMT in the SIERRA trial?

The trial showed a 92% 1-year survival rate and a 69% 2-year survival rate for patients receiving an Iomab-B led BMT.

When and where will the SIERRA trial results be presented?

The results will be presented at the EHA 2024 Congress, held from June 13-16, 2024, in Madrid, Spain.

What is the significance of the SIERRA trial for Actinium Pharmaceuticals?

The SIERRA trial demonstrates significant survival benefits of Iomab-B for high-risk r/r AML patients, showcasing Actinium's advancements in targeted radiotherapies.

What percentage of SIERRA trial patients had a TP53 mutation?

24% (37 out of 153) of the patients enrolled in the SIERRA trial had a TP53 mutation.