- Median Overall Survival of 5.49 months observed
in patients with a TP53 mutation receiving an Iomab-B led
allogeneic bone marrow transplant compared to 1.66 months in
patients that did not receive Iomab-B (hazard ratio=0.23, p=0.0002)
in the Phase 3 SIERRA Trial
- Long-term efficacy results in older patients
with active relapsed or refractory acute myeloid leukemia also
observed in the SIERRA trial
NEW
YORK, May 14, 2024 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the
Company), a leader in the development of Antibody Radiation
Conjugates (ARCs) and other targeted radiotherapies, today
announced that results from the Phase 3 SIERRA trial of Iomab-B
have been accepted for an oral presentation and poster presentation
at the 2024 European Hematology Association (EHA) Hybrid Congress
being held June 13 – 16, 2024, in
Madrid, Spain. The Phase 3 SIERRA
trial enrolled 153 patients ages 55 and above with active relapsed
or refractory acute myeloid leukemia (r/r AML) and compared
outcomes of patients receiving an Iomab-B led bone marrow
transplant (BMT) to those of patients receiving physician's choice
of care in the control arm. Across all patients in SIERRA study,
only patients receiving an Iomab-B led BMT achieved the trial's
primary endpoint of durable complete remission with these patients
having 92% 1-year survival and 69% 2-year survival with
statistically significant higher event free survival. The SIERRA
trial enrolled high-risk patients including those with one or more
of the following: a TP53 mutation, advanced age up to 77 years old,
complex cytogenetics and prior therapy including venetoclax and
other targeted agents.
In total, 24% (37/153) of the patients enrolled on SIERRA had a
TP53 mutation, which is usually associated with limited treatment
options and poor outcomes. Median Overall Survival of 5.49 months
observed in patients with a TP53 mutation receiving an Iomab-B
led allogeneic bone marrow transplant compared to 1.66 months in
patients that did not receive Iomab-B (hazard ratio=0.23,
p=0.0002).
Iomab-B EHA presentations titles are as follows:
Oral Presentation
131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT
RESULTS IN IMPROVED SURVIVAL OUTCOMES IN R/R AML PATIENTS WITH
HIGH-RISK TP53 MUTATIONS IN THE RANDOMIZED PHASE III SIERRA
TRIAL
Poster Presentation
LONG TERM EFFICACY RESULTS OF THE SIERRA TRIAL: A PHASE 3 STUDY
OF 131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL
TRANSPLANTATION VERSUS CONVENTIONAL CARE IN OLDER PATIENTS WITH
ACTIVE, R/R AML
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
230 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.
Investors:
investorrelations@actiniumpharma.com
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SOURCE Actinium Pharmaceuticals, Inc.