Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the
Company”), a clinical-stage biotechnology company developing novel
LAG-3 immunotherapies for cancer and autoimmune disease, today
announces that efti, a soluble LAG-3 protein and first-in-class MHC
Class II agonist, in combination with MSD’s (Merck & Co., Inc.,
Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab)
achieved robust initial Overall Survival (OS) in 1st line non-small
cell lung cancer (1L NSCLC) patients in the Phase II TACTI-002
trial.
This immuno-oncology (IO) investigational
combination, without the use of chemotherapy, led to excellent
initial survival results in the overall intent-to-treat (ITT) 1L
NSCLC patient population (N=114), regardless of PD-L1 expression
status. Importantly, an initial median OS of 25 months has been
attained in those 1L NSCLC patients (N=58) who have a PD-L1 Tumor
Proportion Score (TPS) of >1%, a key area of focus for efti’s
future clinical development and for which Fast Track designation
was granted in October 2022.
Notably, the median 25.0-month OS compares
favourably to reported historical results for patients with the
same PD-L1 TPS of >1% from registration trials of:
- anti-PD-1 monotherapy (16.4-month
median OS); and
- combinations of anti-PD-1 with
chemotherapy (15.8-to-23.3-month median OS) or with anti-CTLA-4
(17.1-month median OS).
Based on the exceptional survival data with a
minimum follow-up of now 14 months, the Data Monitoring Committee
recommends extending the OS follow-up collection to show mature
3-year and potentially 5-year survival rates of this novel IO-IO
combination.
Collectively, the breadth of efficacy and safety
data emerging from the large number of 1L NSCLC patients in the
Phase II TACTI-002 trial offers compelling evidence of efti’s
substantial impact in safely stimulating the patients’ immune
response to fight cancer. These initial OS results are supported by
a strong interim median Duration of Response of 21.6 months in the
ITT population (N=114), including over one-third of patients with
negative PD-L1 expression (N=32), and the high 48.3% response rate
achieved with efti in combination with pembrolizumab in 1L NSCLC
patients with a PD-L1 TPS of >1% (N=58), as reported in a
late-breaking oral abstract presentation at the Society for
Immunotherapy of Cancer (SITC) Meeting in 2022.
Dr Martin Forster of the UCL Cancer Institute
and University College London Hospital NHS Foundation, London, UK,
and TACTI-002 Investigator, said: “These initial overall survival
results from the TACTI-002 trial are clinically meaningful and
build upon the strength of the efficacy data emerging from this
exciting novel investigational combination of efti with
pembrolizumab. Importantly, the favourable safety profile of this
immunotherapy regimen has continued, and to see these deep and
durable responses without any additional toxicity from what would
be expected from anti-PD-1 monotherapy is very encouraging.”
“Efti’s clinical results achieved to date in
combination with pembrolizumab are increasingly robust and continue
to justify the attention given to this novel IO-IO combination
through invitations to make oral presentations at two prestigious
conferences, ASCO and SITC, last year. We now are showing excellent
initial overall survival, which is the gold standard benchmark
within oncology, across the entire intent-to-treat population of
1st line NSCLC patients in our Phase II trial. For non-small cell
lung cancer patients with >1% PD-L1 expression, a key focus for
future development and for which efti in combination with
pembrolizumab has Fast Track status, the survival benefit is
impressive. We look forward to presenting more mature data at a
major medical conference later this year,” said Marc Voigt,
Immutep’s CEO.
“This new data adds to the body of evidence that
efti’s novel activation of antigen-presenting cells provides a
powerful boost to the immune system, which furthers the potential
of immune checkpoint inhibitors. Fundamentally, efti is leading to
a significant systemic expansion of memory cytotoxic T cells that
anti-PD-(L)1 therapies can act upon. Indeed, the combination of
efti plus anti-PD-1 leads to a superior median OS of 25.0-months as
compared to 17.1-months for the registered IO-IO combination of
anti-PD-1 plus anti-CTLA-4, with much less toxicity. Perhaps most
importantly, as the only MHC Class II agonist in clinical
development today, efti is generating this profound immune response
across a variety of solid tumour indications, even with low PD-L1
expression, in a unique and safe manner,” noted Frédéric Triebel,
M.D., Ph.D, Immutep’s CSO.
Lung cancer is the second most common cancer.
Non-small cell lung cancer accounts for approximately 80-85% of all
lung cancers, impacting an estimated 1.87 million people annually,
and is the highest cause of death among all cancers 1-3.
KEYTRUDA® is a registered trademark of Merck
Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.
About Eftilagimod Alpha (Efti)
Efti is Immutep’s proprietary soluble LAG-3
protein and MHC Class II agonist that stimulates both innate and
adaptive immunity for the treatment of cancer. As a first-in-class
antigen presenting cell (APC) activator, efti binds to MHC (major
histocompatibility complex) Class II molecules on APC leading to
activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper
T cells, dendritic cells, NK cells, and monocytes. It also
upregulates the expression of key biological molecules like IFN-ƴ
and CXCL10 that further boost the immune system’s ability to fight
cancer.
Efti is under evaluation for a variety of solid
tumours including non-small cell lung cancer (NSCLC), head and neck
squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its
favourable safety profile enables various combinations, including
with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has
received Fast Track Designation in 1st line HNSCC and in 1st line
NSCLC from the United States Food and Drug Administration
(FDA).
About the TACTI-002
TrialTACTI-002 (Two ACTive Immunotherapies) is being
conducted in collaboration with Merck & Co., Inc., Rahway, NJ,
USA (known as “MSD” outside the United States and Canada). The
study is evaluating the combination of eftilagimod alpha (efti)
with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients
with second line head and neck squamous cell carcinoma or non-small
cell lung cancer in first and second line. The trial is a Phase II,
Simon’s two-stage, non-comparative, open-label, single-arm,
multicentre clinical study that is taking place in study centres
across Australia, Europe, and the US.
Patients participate in one of the
following:
- Part A - first line Non-Small Cell
Lung Cancer (NSCLC), PD-X naïve
- Part B - second line NSCLC, PD-X
refractory
- Part C – second line Head and Neck
Squamous Cell Carcinoma (HNSCC), PD-X naïve
TACTI-002 is an all-comer study in terms of
PD-L1 status, a well-known predictive marker for response to
pembrolizumab monotherapy especially in NSCLC and HNSCC. More
information about the trial can be found on Immutep’s website or on
ClinicalTrials.gov (Identifier: NCT03625323).
About ImmutepImmutep is a
clinical stage biotechnology company developing novel LAG-3
immunotherapy for cancer and autoimmune disease. We are pioneers in
the understanding and advancement of therapeutics related to
Lymphocyte Activation Gene-3 (LAG-3), and our diversified product
portfolio harnesses its unique ability to stimulate or suppress the
immune response. Immutep is dedicated to leveraging its expertise
to bring innovative treatment options to patients in need and to
maximise value for shareholders. For more information, please visit
www.immutep.com.
Australian
Investors/Media:Catherine Strong, Citadel-MAGNUS+61 (0)406
759 268; cstrong@citadelmagnus.com
U.S. Media:Chris Basta, VP,
Investor Relations and Corporate Communications+1 (631) 318 4000;
chris.basta@immutep.com
-------------------1 The Global Cancer
Observatory, Lung Cancer Fact Sheet2 American Cancer Society, About
Lung Cancer 3 CDC, Lung Cancer Statistics
Immutep (NASDAQ:IMMP)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Immutep (NASDAQ:IMMP)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024