Actinium Pharmaceuticals Shares Promising Results of Actimab-A in AML Treatment in Peer-Reviewed Journal

Actinium Pharmaceuticals, renowned for its breakthroughs in targeted radiotherapies, has made significant waves in the oncology field with the recent publication of clinical trial findings on Actimab-A in combination with CLAG-M. These results, highlighted in the peer-reviewed journal Leukemia, showcase the potential of this therapy for patients suffering from relapsed or refractory Acute Myeloid Leukemia (AML).

Trial Overview


The clinical trial focused on patients with r/r AML, many of whom had undergone one or two prior lines of therapy. Impressively, the study reported a median overall survival (OS) of 18.4 months, a substantial improvement considering previous median survival rates in similar patients. For context, patients who previously failed treatments such as Venetoclax typically faced a dire prognosis, with median survival dropping to between 2.4 to 4.6 months.

Noteworthy Outcomes


  • - High-Response Rates: A striking 52% of trial participants presented with TP53 mutations, a common and detrimental genetic alteration associated with poor outcomes in AML. However, the novel combination therapy achieved a notable high rate of measurable residual disease negativity (MRD-), with 75% across all participants.
- Among those with TP53 mutations, the rate remained significant at 83.3%, reflecting the therapy’s efficacy even in patients with the most difficult profiles.
- Furthermore, all patients who had received prior Venetoclax therapy experienced a remarkable 100% MRD negativity rate, showcasing the treatment's profound impact.

  • - Bone Marrow Transplants: Approximately 71% of eligible participants proceeded to receive a bone marrow transplant, with those undergoing this procedure reporting a median overall survival of 24.05 months.

The principal investigator of the study, Dr. Sameem Abedin, emphasized the importance of these findings. He stated that the clinical trial offers hope by showing that even high-risk patients, traditionally viewed as having limited treatment options, can achieve deep remissions with this combination therapy. Abedin expressed excitement for the anticipated Phase 2/3 trial following the promising results, reinforcing the therapeutic potential of targeted radiotherapy in AML treatment.

Next Steps


Actinium Pharmaceuticals is set to advance to pivotal clinical trials following these outcomes. The upcoming Phase 2/3 trial promises to optimize dosage levels for Actimab-A while also comparing patient outcomes against the standard CLAG-M treatment alone. This seamless operational plan aims to kick off in 2025, further solidifying Actinium's role in defining the future of AML treatments.

CEO Sandesh Seth noted that this momentum aligns with the company’s overarching goal of addressing the needs of over 100,000 AML and MDS patients across the U.S. and Europe. He stated their commitment to exploring Actimab-A's potential within the multi-billion-dollar market, anticipating further data to support its broad application across various myeloid malignancies.

Conclusion


Actinium Pharmaceuticals stands at the forefront of a potentially groundbreaking therapeutic approach for AML. As they prepare for upcoming trials, the combination of Actimab-A and CLAG-M could signal a new era of hope for patients with this challenging malignancy. With ongoing research and understanding, there remains optimism for significantly improved outcomes within this underserved patient population.

For further updates and information regarding ongoing research and initiatives, visit Actinium Pharmaceuticals.

Topics Health)

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