Novel treatment for patients with relapsed or refractory AML

December 12, 2022 Off By Dino Mustafić

Actinium highlighted high rates of Complete Remission (CR/CRi) and rates of measurable residual disease (MRD) negativity with improved overall survival in its Actimab-A CLAG-M combination trial in high-risk patients with relapsed or refractory (r/r) acute myeloid leukemia (AML).

Actinium detailed this in an oral presentation at the 64th Annual ASH Meeting & Symposium being held December 10-13, 2022 in New Orleans, Louisiana.

Actinium said that the trial enrolled patients with intermediate and adverse cytogenetics including over 50% with a TP53 mutation and significant prior treatment with a median of 2 lines of therapy and over 57% having prior Venetoclax based therapy. The addition of Actimab-A to CLAG-M was well tolerated with expected toxicities.


Dr. Sameem Abedin said: “The high rates of MRD negativity and strong survival outcomes, especially in the TP53 mutant and Venetoclax treated patients, is highly encouraging and represents a significant improvement compared to available therapies for these patients. The patients enrolled on this trial have very difficult to treat AML and a dismal prognosis with an expected survival of 2 to 3 months or less. They also have very limited treatment options. High rates of 1-year survival are rare in these patients and 2-year survival is rarely achieved. With Venetoclax treatment becoming standard of care, it is critical that we find a therapy for the high percentage of patients who do not respond or relapse and therapies with better outcomes for all relapsed or refractory patients. Outside of this novel clinical trial, these patients would not have been considered for CLAG-M treatment as it would not be expected to have this type of effect in patients who had failed venetoclax based on our considerable prior experience with this regimen. Importantly, the combination was well tolerated with manageable toxicities and enabled a significant number of patients to proceed to transplant. These data support advancing the Actimab-A CLAG-M combination in a registration enabling study.”

Dr. Avinash Desai, Actinium’s Chief Medical Officer, said: “As a first-in-class targeted radiotherapy, Actimab-A represents a novel treatment for patients with relapsed or refractory AML. Its differentiated mechanism of action attacks leukemia cells with a radioactive payload that the cancer cells have never been exposed to, which we believe is driving improved outcomes in these heavily pretreated and adverse cytogenetic patients. The high rates and deep remissions evidenced by the 75% measurable residual disease negativity are exciting and support the hypothesis of this combination. We are thrilled to show improved survival, especially in the TP53 mutant and Venetoclax treated patients who have dismal outcomes with expected survival of less than 3 months and few, if any, treatment options. With enrollment of this study complete, we look forward to leveraging the strong survival, MRD negativity and complete remission results to rapidly establish an efficient development and regulatory strategy.”