- 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 patients
with active relapsed or refractory acute myeloid leukemia also
observed in the SIERRA trial
NEW
YORK, June 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
were presented at the 2024 European Hematology Association (EHA)
Hybrid Congress being held June 13 –
16, 2024, in Madrid, Spain. The
two presentations at EHA highlighted outcomes in patients with
active relapsed or refractory acute myeloid leukemia (r/r AML)
enrolled in the SIERRA trial who had a TP53 mutation and long-term
efficacy results in this older patient population.
The Phase 3 SIERRA trial enrolled 153 patients ages 55 and above
with active 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.
Highlights from Oral Presentation of Outcomes in Patients
with a TP53 Mutation
- 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
- For patients with TP53 mutation only those receiving
Iomab-B (either at randomization or via cross-over) achieved
complete remission or achieve a durable complete remission (dCR),
the primary endpoint of the SIERRA trial
- Median Overall Survival (OS) 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)
- Median OS was 6.37 months in TP53 negative patients
receiving Iomab-B and 5.72 months for TP53 positive patients
demonstrating Iomab-B's ability to overcome TP53 gene mutations
Presentation Title: 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
Presenter: Dr. Hannah
Choe, Assistant Professor of Medicine at Ohio State University and SIERRA trial
investigator
Highlights from Presentation of Long-Term Efficacy
Results
- All patients receiving Iomab-B underwent
a BMT compared to 18% on the control arm
- 75% of patients on the Iomab-B arm achieved a complete
remission (CR) compared to 6.3% on the control arm
- The durable complete remission (dCR) was 22% on the Iomab-B
arm compared to 0% on the control arm. dCR is the primary endpoint
of the SIERRA study and was met with high statistical significance
with a p-value<0.0001
- Of the patients achieving dCR after an Iomab-B led BMT,
there was 92% 1-year survival and 69% 2-year survival with median
overall survival not reached
- Iomab-B was well tolerated with a favorable safety profile
including lower rates of sepsis and mucositis in patients receiving
an Iomab-B led BMT
Presentation Title: 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.