Iomab-B New Trial - SEC Quarterly Report.
- Actinium believes it has aligned with the FDA on the patient population for a head-to-head Phase 3 clinical trial to evaluate allogeneic BMT further using Iomab-B plus a reduced intensity conditioning regimen of Flu/TBI versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI in all adult patients aged 18 and above with active AML with blasts counts greater than 5% and less than 20%. This is a broader patient population than those enrolled in the SIERRA trial, which only enrolled patients aged 55 and above.
- Further, the FDA now requires that an additional dose optimization trial demonstrating safety and efficacy be completed to calculate the dose of Iomab-B based on the absorbed dose by the bone marrow, rather than the maximum tolerable dose of 24 Gy of radiation to the liver as was done in the SIERRA trial based on several interactions we had with the FDA before starting the SIERRA trial.
- We are actively seeking a strategic partner for Iomab-B in the U.S. to advance the head-to-head clinical trial or other clinical development activity for Iomab-B."
Patients - One of the pending questions for the Actinium Annual Shareholder meeting is when will the new Iomab-B trial begin. It is expected patients will be able to enroll in the trial at the original 24 SIERRA study locations. (https://clinicaltrials.gov/study/NCT02665065; Contacts and Locations section). Due to the FDA delay, this appears to be the quickest way for patients to access Iomab-B. However, due to randomization, there is no guarantee that patients will be administered Iomab-B or the control arm treatment.
Iomab-B SIERRA Trial results -
Full disclosure of the results from the SIERRA Trial was posted in the ASCO Journal of Clinical Oncology.
https://ascopubs.org/doi/10.1200/JCO.23.02018
Of interest:
- Measurable Residual Disease (MRD) Positive vs. MRD Negative pre-transplant is a high predictor of relapse. New Iomab-B Phase 3 trial should ensure they measure MRD status before and after Iomab-B vs control; prior to transplant. https://ascopubs.org/doi/10.1200/EDBK_390010
- Patients benefit from Iomab-B. The significant difference in dCR rates between arms (and the longer survival in patients with dCR) demonstrates the therapeutic potential of 131I-apamistamab in this patient population. Patients who crossed over to receive 131I-apamistamab after failing salvage therapy had similar outcomes to those originally randomly assigned to 131I-apamistamab.
- Per protocol - Cross-over Confounding. Actinium should contest the FDA. "All subjects that cross-over to the Iomab-B treatment regimen will not be counted as either having achieved or failed to achieve the primary endpoint in the Iomab-B Treatment Group, regardless of the outcome of their subsequent treatment with Iomab-B." "Crossover Cohort The crossover cohort will include all subjects randomized to the CC Group who are crossed over to receive treatment with Iomab-B. This cohort will serve as the basis for a separate summary of efficacy and safety outcomes between randomized treatment period and crossover portion."
https://ascopubs.org/action/downloadSupplement?doi=10.1200%2FJCO.23.02018&file=protocol-SAP+1_jco.23.02018.pdf
Annual Meeting Notification
For investors with Actinium Pharmaceuticals.
The proxy statement and the 2023 Annual Report are also available at https://web.viewproxy.com/actiniumpharma/2024
You are cordially invited to attend the Annual Meeting of Stockholders (the “Annual Meeting”) of Actinium Pharmaceuticals, Inc. to be held at 9:30 a.m., Eastern Time, on November 27, 2024, at The Garden City Hotel, 45 Seventh St, Garden City, NY 11530.