- Extended follow-up in the Actimab-A +
CLAG-M trial showed median overall survival in patients proceeding
to bone marrow transplant of 24 months in all patients and 30
months in patients who received prior venetoclax treatment
- Actimab-A shown to enhance the anti-leukemic
activity of FLT3 inhibition of approved therapies gilteritinib and
midostaurin preclinically, supporting the clinical evaluation of
Actimab-A combinations with FLT3 inhibitors
NEW
YORK, Sept. 7, 2023 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the
Company), a leader in the development of targeted radiotherapies,
today highlighted updated survival data from its Phase 1b trial evaluating Actimab-A in combination with
the salvage chemotherapy CLAG-M in patients with high-risk relapsed
or refractory acute myeloid leukemia (r/r AML) and new preclinical
data with Actimab-A in combination with FLT3 inhibitors at the
Society of Hematologic Oncology (SOHO) 2023 Annual Meeting. In
addition, results of the completed and positive Phase 3 SIERRA
trial of Iomab-B were presented.
SOHO Data Highlights:
Updated Actimab-A + CLAG-M Phase 1b Study Results:
- 30-month
median Overall Survival (OS) in patients with prior venetoclax
treatment who proceeded to bone marrow transplant (BMT) following
Actimab-A + CLAG-M
- 24-month median OS in all
patients who proceeded to BMT following Actimab-A + CLAG-M
- 100% measurable residual
disease (MRD) negativity in patients with prior venetoclax
treatment and 75% MRD negativity in all patients
- 83% of patients (19/23) had
high-risk r/r AML; 57% of patients (13/23) received prior treatment
with venetoclax
- Patients who relapse after
venetoclax treatment have poor survival outcomes with a limited
percentage of patients proceeding to BMT
Poster Title: Sequential Salvage Chemotherapy and
Lintuzumab-Ac225 in Relapsed/Refractory AML Results in Deep
Responses and Prolonged Survival in Adverse Risk Acute Myeloid
Leukemia (AML) and in AML Patients that Received Prior Venetoclax
Therapy
"These data continue to demonstrate the broad potential and
applicability of targeted radiotherapeutics as well as Actinium's
leadership position in their development for r/r AML and other
blood cancers," said Sandesh Seth,
Actinium Chairman and CEO. "As we progress Actimab-A + CLAG-M to a
pivotal trial, we are highly encouraged by this new follow-up data
showing 100% MRD negativity and median survival of 30 months in
patients proceeding to transplant who had prior venetoclax
treatment. Given the significant number of patients with AML who
receive venetoclax treatment and, unfortunately, have disease
relapse, better therapeutic options are needed for this growing
patient segment. We are excited by the potential of Actimab-A to
meet this high unmet need given its differentiated mechanism of
action and clinical profile thus far."
Actimab-A Program Expansion into FLT3 Mutant
AML:
- Actimab-A
shown to have single-agent cytotoxic activity against FLT3 mutant
AML cell lines
- The addition of Actimab-A
enhances the anti-leukemic activity of FLT3 inhibition of approved
FLT3 inhibitors gilteritinib (Xospata®, Astellas) and midostaurin
(Rydapt®, Novartis) in vitro
- FLT3 mutations are associated
with aggressive disease with poor outcomes and occur in
approximately 30% of patients, making it one of the most commonly
mutated genes in AML
- Combinations of Actimab-A
with FLT3 inhibitors can potentially be explored under Actinium's
CRADA with the NCI
Poster Title: Antileukemic Activity of
Lintuzumab-Ac225 in Preclinical Model of FLT3 Mutant AML
Mr. Seth added, "The mutation agnostic mechanism of action,
potent cell killing ability and synergistic potential of Actimab-A
provides multiple avenues for development as evidenced by this new
preclinical data supporting combinations with FLT3 inhibitors. With
FLT3 gene mutations being the most common in AML, we are excited to
further Actimab-A's backbone potential by continuing to explore
this novel combination that could address approximately 30% of the
AML patient population."
About Actinium
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 200 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.
References:
1) Maiti et al. Outcomes of
relapsed or refractory acute myeloid leukemia after front-line
hypomethylating agent and venetoclax regimens. Hematoligica 2021
Mar 1; 894-898
2) Oñate, G., Pratcorona, M., Garrido,
A. et al. Survival improvement of patients
with FLT3 mutated acute myeloid leukemia: results
from a prospective 9 years cohort. Blood Cancer
J. 13, 69 (2023).
https://doi.org/10.1038/s41408-023-00839-1
Contact:
Matthew Beck
Vice President Investor Relations & Communications
mbeck@actiniumpharma.com
(917) 415-1750
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SOURCE Actinium Pharmaceuticals, Inc.