Actinium Announces Iomab-B Markedly Increases Long Term Survival in Patients 65 Years or Older with Active Relapsed or Refractory AML in the Phase 3 SIERRA Trial at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMTR®
- Unprecedented 100% access to BMT and engraftment in evaluable patients with r/r AML
- Improved long-term survival outcomes greater than 2 years in patients age 65 or older
- Iomab-B demonstrated improved outcomes in patients with high-risk features including a TP53 mutation
- Significantly higher rates of complete remission and durable complete remission in patients receiving Iomab-B
- Improved 1-year and 2-year survival rates in patients receiving Iomab-B compared to the control arm
- None.
Insights
The clinical results from the SIERRA trial for Iomab-B suggest a significant advancement in the treatment of relapsed or refractory acute myeloid leukemia (r/r AML) in older patients. The ability of Iomab-B to facilitate bone marrow transplants (BMT) and achieve engraftment in 100% of evaluable patients is particularly noteworthy, as this patient population typically faces poor prognoses and limited treatment options due to factors such as advanced age, comorbidities and high-risk cytogenetics, including TP53 mutations.
From a medical standpoint, the improved survival rates at one and two years post-transplant are crucial, as they indicate not only immediate treatment success but also longer-term efficacy. The reported complete remission (CR) and durable CR rates further underscore the potential of Iomab-B to change the standard of care in this high-risk patient segment. The tolerance of the targeted conditioning regimen in these patients is also a key factor, as it implies a lower burden of treatment-related toxicity, which is a significant concern in older patients with multiple comorbidities.
From a research perspective, the SIERRA trial's data represent a potential paradigm shift in the management of r/r AML in the elderly. The trial's design, which compares Iomab-B led BMT against the current standard of care, including therapies targeting FLT3 and IDH mutations and venetoclax, helps to contextualize the efficacy of Iomab-B within the existing treatment landscape. The mention of improved outcomes in patients with TP53 mutations is particularly significant, as these mutations are often associated with chemotherapy resistance and poor survival outcomes.
Moreover, the trial's focus on a rapidly growing patient segment—those 65 years and older—addresses a critical gap in current treatment protocols. The ability to offer potentially curative treatments to this demographic could have substantial implications for patient care strategies and healthcare resource allocation. The reported data could influence future clinical guidelines and drive further research into targeted radiotherapy conditioning as a viable option for other high-risk populations.
Actinium Pharmaceuticals' positive Phase 3 trial results could have significant implications for the company's market position and the broader pharmaceutical landscape. The successful demonstration of Iomab-B's efficacy and safety in a challenging patient population not only enhances the company's portfolio but also potentially expands the addressable market for BMT. As an emerging leader in targeted radiotherapies, Actinium's progress in this area could attract the attention of investors, strategic partners and larger pharmaceutical companies looking to diversify their oncology offerings.
The strong interest from the medical and scientific communities, as indicated by the multiple presentations at prestigious conferences, could facilitate faster adoption of Iomab-B upon regulatory approval. For stakeholders, the potential for Iomab-B to meet a significant unmet need in the treatment of r/r AML could translate into a competitive advantage and drive long-term value creation.
- Active relapsed or refractory AML patients 65+ years receiving an Iomab-B led Bone Marrow Transplant (BMT) achieved significant improvement in survival at one and two years compared to control arm patients none of whom survived even one year
- Unprecedented
- Iomab-B has also demonstrated improved outcomes in patients with high-risk features including a TP53 mutation
Dr. Rajneesh Nath, Chief, Stem Cell Transplant, Cellular Therapy and Leukemia at Banner MD Anderson Cancer Center, said, "BMT physicians are eager to have treatment options for patients age 65 or older especially with high-risk factors like those enrolled in SIERRA study as this rapidly growing patient segment continues to have highly restrictive access to BMT due to poor outcomes. The SIERRA results show that Iomab-B targeted conditioning is well tolerated even in these patients with advanced age and multiple-comorbidities, providing access to potentially curative transplant for a substantially greater number of patients compared to the control arm. Patients receiving Iomab-B had significantly higher rates of complete remission as well as durable complete remission compared to the control arm. Most importantly, Iomab-B produced improved long-term survival outcomes as only the patients receiving Iomab-B achieved 1-year and 2-year survival. Iomab-B represents an important advancement in transplant conditioning and has the potential to address a significant unmet patient need."
Response Rates in Patients Age 65 and Above by Treatment Group
Iomab-B (N=28) | Crossover (N=17) | Control Arm (N=9) | |
Achieved CR or CRp | 19 (67.9 %) | 9 (52.9 %) | 3 (33.3 %) |
Achieved durable CR | 5 (17.9 %) | 1 (5.9 %) | 0 (0.0 %) |
Overall Survival in Patients Age 65 and Above by Treatment Received
Iomab-B & Crossover (N=45) | Control Arm (N=9) | |
1-year survival | 20.1 % | 0.0 % |
2-year survival | 11.5 % | 0.0 % |
Sandesh Seth, Actinium's Chairman and CEO, added, "SIERRA was a first of its kind trial to use targeted radiotherapy conditioning to enable potentially curative BMT in patients who are not typically considered for transplant in current practice. Importantly, SIERRA demonstrated superior outcomes with an Iomab-B led BMT to current standard of care in the control arm that included approved therapies targeting FLT3 and IDH mutations and venetoclax, a BCL-2 inhibitor. We are incredibly excited that Iomab-B led BMT improved outcomes across all major patient segments including patients with advanced age and comorbidities, treatment resistant disease and high-risk features including TP53 mutations, which are mostly associated with dismal outcomes. We also are highly encouraged by the strong continued receptivity for Iomab-B data from the SIERRA trial by key medical and scientific communities both in US and
About the TCT Tandem Meetings
The Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR are the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Administrators, clinicians, data manager / clinical research professionals, fellows-in-training, investigators, laboratory technicians, MD/PhDs, nurses, nurse practitioners, pharmacists, physician assistants, and other allied health professional attendees benefit from a full scientific program that addresses the most timely issues in hematopoietic cell transplantation and cellular therapy.
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 220 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.
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FAQ
What are the key highlights of Actinium Pharmaceuticals, Inc.'s Phase 3 SIERRA trial results for Iomab-B?
What were the response rates in patients age 65 and above who received Iomab-B?
How did the overall survival rates compare between patients age 65 and above who received Iomab-B and the control arm?
Who is Actinium Pharmaceuticals, Inc.'s Chairman and CEO?
What sets the SIERRA trial apart from current transplant practices?
