Actinium Announces Oral Presentation at ASH Annual Meeting Highlighting Iomab-B Treatment Significantly Increased Median Overall Survival in Relapsed or Refractory AML Patients with Highly Unfavorable TP53 Gene Mutation in the Phase 3 SIERRA Trial
- The Phase 3 SIERRA trial showed that AML patients with a TP53 mutation who received Iomab-B and a bone marrow transplant had a median overall survival of 5.49 months compared to 1.66 months in patients who did not receive Iomab-B.
- Iomab-B demonstrated similar overall survival outcomes in TP53 negative patients, with a median overall survival of 6.37 months.
- 24% of patients enrolled in the SIERRA trial had a TP53 mutation.
- None.
- Relapsed or refractory AML patients with a TP53 mutation receiving Iomab-B led allogeneic bone marrow transplant had a median Overall Survival of 5.49 months compared to 1.66 months in patients that did not receive Iomab-B (hazard ratio=0.23, p=0.0002)
- Iomab-B's mutation-agnostic mechanism overcomes TP53 mutations and produced similar median Overall Survival outcomes of 6.37 months in TP53 negative patients and 5.72 months in TP53 positive patients
- Twenty-four percent of patients enrolled on SIERRA had a TP53 mutation that is typically associated with worse outcomes
- Oral presentation scheduled for Sunday, December 10, 2023, with two additional poster presentations detailing SIERRA trial results accepted for presentation
- Actinium reports third quarter financial results and provides a business update
- Median Overall Survival (OS) of TP53 positive patients receiving Iomab-B and a bone marrow transplant (BMT) was 5.49 months compared to 1.66 months in patients who did not receive Iomab-B
- Iomab-B produced a statistically significant improvement in median OS in TP53 positive patients with a hazard ratio of 0.23 and p-value of 0.0002
- Median OS of 6.37 months in TP53 negative patients receiving Iomab-B and 5.72 months for TP53 positive patients demonstrating Iomab-B's mutation agnostic mechanism and ability to overcome TP53 gene mutations
24% of patients (37/153) enrolled on the SIERRA trial had a TP53 mutation, with 17 being randomized to the Iomab-B arm and 20 randomized to the control arm
Dr. Avinash Desai, Actinium's Chief Medical Officer, commented, "We are very excited by these results which show a statistically significant and greater than three-times increase in median OS in TP53 positive patients receiving Iomab-B. These results further support Iomab-B's differentiated profile and ability to improve outcomes for the most difficult to treat r/r AML patients. A TP53 gene mutation is arguably the most unfavorable risk factor leading to the worst patient outcomes as it is associated with inherent resistance to available therapies, short duration of responses and the lowest survival rates. Despite being a common mutation found in approximately 10
Detailed results will be presented in an oral presentation on December 10, 2023, as follows:
Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Novel Conditioning Regimens for Myeloid Malignancies
Session Date: Sunday, December 10, 2023
Session Time: 9:30 AM - 11:00 AM Pacific Time
Presentation Time: 9:30 AM
Room: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 18-19
Publication Number: 469
Title: 131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML
Submission ID: 182177
Sandesh Seth, Actinium's Chairman and CEO, added, "This oral presentation at ASH represents the eighth oral presentation from the SIERRA results in 2023. Through these presentations, we have built strong recognition for Iomab-B's unique clinical profile and utility in this disease with high unmet medical need amongst key medical and scientific communities comprised of BMT physicians, hematologists, nuclear medicine physicians, nurses and transplant coordinators. These additional data in TP53 positive patients further supports the potential of targeted radiotherapy in heterogenous, difficult-to-treat blood cancers given its mutation-agnostic mechanism of action. Further, we believe the broad expression of CD45 enables development of Iomab-B across various blood cancers, as well as cell and gene therapy with our next-generation conditioning agent, Iomab-ACT, allowing Actinium to address a significant patient need."
Additional SIERRA data will be presented in two poster presentations as follows:
Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster I
Session Date: Saturday, December 9, 2023
Presentation Time: 5:30 PM - 7:30 PM Pacific Time
Location:
Publication Number: 2159
Title: 131I-Apamistamab Effectively Achieved Durable Responses in Patients with R/R AML Irrespective of the Presence of Multiple High-Risk Factors
Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00 PM - 8:00 PM Pacific Time
Location:
Publication Number: 3529
Title: High-Dose Targeted Radiation with 131I-Apamistamab Prior to HCT Demonstrated a Dose-Response for Durable Complete Remission in Patients with R/R AML
Financial results and business update
On November 2, 2023, Actinium reported financial results for the third quarter 2023 and provided a business update. For additional information, refer to the Company's Form 10-Q for the third quarter 2023 filed with the SEC on November 2, 2023, which should be read in addition to this press release.
Cash and cash equivalents: The Company reported cash and cash equivalents of approximately
Research and Development Expense, net of reimbursements: Research and development expenses of
General and Administrative Expense: General and administrative expenses of
Other Income: Other income is comprised of net interest income in both reporting periods. The amount for the third quarter 2023 of
Net Loss: Net loss of
Actinium also provided an update on its regulatory activity pertaining to its planned Biologics License Application (BLA) for Iomab-B as well as the planned marketing authorization application (MAA) to the European Medicines Agency (EMA) that will be completed by Immedica Pharma AB (Immedica), Actinium's European,
About Iomab-B and the Pivotal Phase 3 SIERRA Trial
Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. Multiple studies have demonstrated increased survival in patients receiving BMT, however, an overwhelming majority of patients with blood cancers do not receive BMT as current approaches do not produce a remission, which is needed to advance to BMT, or are too toxic. Studied in over 400 patients, prior studies with Iomab-B have demonstrated nearly universal access to BMT, increased survival and tolerability in multiple clinical trials including the recently completed pivotal Phase 3 SIERRA trial in patients with active (leukemic blasts >
Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6 months after initial remission post-BMT in the pivotal Phase 3 SIERRA trial with high statistical significance (p<0.0001). Iomab-B produced a
The pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly relapsed or refractory AML) is a 153-patient, randomized, multi-center clinical trial, studying Iomab-B compared to the control arm of physician's choice of salvage therapy. Control arm options included chemotherapies like cytarabine and daunorubicin and targeted agents such as a Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors. The SIERRA control arm reflects real-world treatment of r/r AML patients with over 20 agents used alone or in combination as no standard of care exists for this patient population. The SIERRA trial enrolled patients at 24 leading transplant centers in
Developed at the Fred Hutchinson Cancer Research Center, a pioneer in the field of BMT, Iomab-B is supported by data in six disease indications including leukemias, lymphomas and multiple myeloma, which afflict over 100,000 patients annually. Actinium intends to pursue additional indications for Iomab-B beyond AML. Actinium also intends to pursue international regulatory approvals independently and through partnerships. In April 2022, Actinium licensed the European,
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), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic, 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's technology platform is the basis for collaborations with Astellas Pharma for solid tumors, AVEO Oncology/LG Chem Life Sciences for HER3 solid tumors, and several internal programs in solid tumors. Actinium holds more than 220 patents and patent applications.
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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Sources: Granowicz EM, Jonas BA. Targeting TP53-Mutated Acute Myeloid Leukemia: Research and Clinical Developments. Onco Targets Ther. 2022 Apr 21;15:423-436. doi: 10.2147/OTT.S265637. PMID: 35479302; PMCID: PMC9037178.
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