Immutep Announces Promising New Clinical Data from Triple Combination Therapy in INSIGHT-003 Trial
24 Mai 2023 - 2:00PM
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 new encouraging clinical data in 1st line non-small cell
lung cancer from INSIGHT-003, an investigator-initiated Phase I
trial conducted by the Frankfurt Institute of Clinical Cancer
Research IKF. INSIGHT-003 is the first study evaluating eftilagimod
alpha (“efti”), a soluble LAG-3 protein and MHC Class II agonist,
in conjunction with standard-of-care anti-PD-1 therapy and doublet
chemotherapy (carboplatin/pemetrexed).
The triple combination therapy remains
well-tolerated and continues to show promising initial efficacy
signals attaining a 67% overall response rate (ORR) and 91% disease
control rate (DCR) in advanced or metastatic non-squamous 1st line
non-small cell lung cancer patients (N=21). Notably, 81% (17/21) of
patients had a PD-L1 Tumor Proportion Score (TPS) of <50%, who
are less responsive to anti-PD-1 based therapy compared with PD-L1
high expressing patients.
The 67% ORR regardless of PD-L1 expression and
65% response rate in patients with PD-L1 TPS <50% for the triple
combination compare favourably to reported results from a
registrational trial of anti-PD-1 and doublet chemotherapy in the
same patient population that yielded an ORR of 48% regardless of
PD-L1 expression and a response rate of 40.8% in patients with
PD-L1 TPS <50%.
Immutep CSO, Dr. Frédéric Triebel, said:
“Immutep has made significant progress with our late-stage
development planning to treat one of the largest cancer indications
globally. We are uniquely positioned to address PD-L1 low (TPS
1-49%) and high (TPS >50%) expressing patients, representing
roughly 65% of the non-small cell lung cancer patient population,
with powerful chemo-free IO-IO approaches, and potentially the
entire patient population when including the IO-IO-chemo
combination being tested in INSIGHT-003. Powering both options is
eftilagimod alpha, the only MHC Class II agonist in clinical
development, safely generating a broad immune response to fight
cancer.”
Patients with high, low, and negative PD-L1
expression represent approximately 30%, 35%, and 35%, respectively,
of the 1st line non-small cell lung cancer (1L NSCLC) patient
population. Low and negative PD-L1 expressors (patients with a
PD-L1 TPS of 1-49% and <1%) are less responsive to anti-PD-(L)1
therapy compared to patients with high levels or PD-L1 TPS of
≥50%.
Unlike many immuno-oncology combinations (IO-IO)
that focus on high PD-L1 expressing patients, compelling clinical
results to date from the TACTI-002 Phase II trial suggest that efti
may be uniquely positioned to effectively address low and high
PD-L1 expressors (~65% of 1L NSCLC patient population) through
chemo-free IO-IO combinations, and potentially the entire NSCLC
patient population, regardless of PD-L1 expression, when adding the
IO-IO-chemo triple combination.
Prof. Dr. Salah-Eddin Al-Batran of the Institute
of Clinical Cancer Research IKF and lead investigator noted: “These
initial results are supportive of efti’s synergies with both
anti-PD-1 therapy and chemotherapy in the clinical setting, and we
are pleased with the data to date from this novel IO-IO-chemo
combination. Efti’s ability to safely engage such a robust immune
response for cancer patients via MHC Class II agonism is truly
unique, and we look forward to providing more data from this triple
combination therapy at a major medical conference this year.”
The INSIGHT-003 trial was recently expanded to
enroll 50 patients across multiple sites based on the favourable
safety and efficacy results, and additional data is expected to be
presented at a major medical conference in H2 CY2023.
About INSIGHT-003INSIGHT-003 is
an investigator-initiated study conducted by the Institute of
Clinical Cancer Research IKF. It is being run as the third arm
(Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr.
Salah-Eddin Al-Batran as lead investigator. The study is evaluating
a triple combination therapy in front line non-small cell lung
cancer patients consisting of efti administered subcutaneously in
conjunction with an existing approved standard-of-care combination
of anti-PD-1 therapy (pembrolizumab) and chemotherapy (carboplatin
and pemetrexed) delivered intravenously. The trial will assess the
safety, tolerability, and initial efficacy of the combination.
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 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
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