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
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.
- 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.
- 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.
Insights
Actinium Pharmaceuticals' Phase 3 SIERRA trial results are particularly significant for the oncology community and patients battling acute myeloid leukemia (AML), especially those with a TP53 mutation. TP53 mutations are often considered high-risk and are associated with poor prognosis and limited treatment options. The median overall survival improvement from 1.66 months to 5.49 months with Iomab-B treatment is highly notable. This substantial increase in survival indicates that Iomab-B could represent a meaningful advancement in the treatment landscape for high-risk AML patients.
Moreover, this treatment's capacity to achieve a 92% 1-year survival rate and 69% 2-year survival rate, compared to conventional care, underscores its potential efficacy. These figures are compelling, especially given the advanced age and prior treatment history of the patient cohort. This suggests that Iomab-B could provide a critical lifeline for older patients who are often excluded from other aggressive treatments due to their frailty.
From an investment perspective, the promising results of the Phase 3 SIERRA trial could be a pivotal catalyst for Actinium Pharmaceuticals. The statistical significance of these findings (p=0.0002) and the demonstrated hazard ratio of 0.23 are key indicators of the robustness of Iomab-B's efficacy. This not only bodes well for the drug's potential FDA approval but also for its commercial viability in a market with high unmet needs.
Financially, the enhanced survival outcomes could drive substantial revenue growth upon market entry, attracting both institutional and retail investors. Furthermore, the acceptance of these results for an oral presentation at the EHA Congress adds a layer of credibility and visibility among the global medical community. Investors should, however, consider the long-term commercialization challenges, including potential competition and pricing strategies, which could impact profitability.
The acceptance of SIERRA trial results for presentation at the prestigious European Hematology Association Hybrid Congress is a significant milestone. It demonstrates the medical community's recognition of Iomab-B's potential impact. The target market for this therapy includes older patients with relapsed or refractory AML, a segment with limited treatment options and generally poor outcomes.
Considering the high-risk nature of the enrolled patient cohort, the impressive survival benefits provide a strong competitive advantage. The focus on older patients—who often face limited treatment choices due to their age—could fill a vital niche. This positions Actinium Pharmaceuticals favorably within the oncology market, enhancing its competitive edge. Monitoring the long-term market adoption and patient response will be vital to gauge the full impact of these trial results.
- 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
In total,
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:
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FAQ
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