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
provides an overview of the positive final data from Part C of the
TACTI-002 Phase II trial to be presented in a poster presentation
at the ASCO 2023 Annual Meeting taking place in Chicago, US.
Part C of TACTI-002 evaluated eftilagimod alpha
(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) in 2nd line
head and neck squamous cell carcinoma (2L HNSCC) patients
unselected for PD-L1 expression (N=37), with disease progression
on, or after, platinum-based therapy (± cetuximab).
The combination of efti plus pembrolizumab led
to an encouraging overall response rate (ORR) of 29.7% and Complete
Response (CR) rate of 13.5% in 2L HNSCC patients, regardless of
PD-L1 expression, as per iRECIST (RECIST 1.1 results were
comparable). Responses were seen across all PD-L1 subgroups. A
promising ORR of 38.5% & 60%, median Overall Survival (mOS) of
12.6 & 15.5 months, and 12-month Overall Survival (OS) rate of
52.0% & 66.7%, were seen in patients with a PD-L1 CPS of ≥1 and
a PD-L1 CPS ≥20, respectively. Despite a long median follow up of
39 months, median Duration of Response (mDoR) was not reached.
(Table 1)
Results compare favourably to reported results
from a registrational trial of anti-PD-1 monotherapy in the same
patient population with a PD-L1 CPS ≥1, which showed a 17.3% ORR,
mOS of 8.7 months, 12-month OS rate of 40%, a CR rate of 2%, and
mDoR of 18.4 months.1
Table 1 – Efficacy Endpoints Across PD-L1
Subgroups in 2nd line HNSCC (TACTI-002, Part C) as per iRECIST
|
Overall (N=37) |
CPS ≥1 (N=25) |
CPS ≥20 (N=15) |
Overall Response Rate (ORR), % |
29.7 |
38.5 |
60.0 |
Median Progression-Free Survival (mPFS), months |
2.1 |
2.3 |
13.6 |
6-month PFS rate, % |
32.4 |
40.0 |
53.3 |
Median Overall Survival (mOS), months |
8.7 |
12.6 |
15.5 |
12-month OS rate, % |
46.0 |
52.0 |
66.7 |
Median Duration of Response (mDoR), months |
Not Reached |
Not Reached |
Not Reached |
Dr. Bernard Doger of START Madrid-FJD, Fundación
Jiménez Díaz University Hospital and TACTI-002 and TACTI-003
investigator said, “The high overall and complete response rates
for patients in Part C of the TACTI-002 trial, taken alongside
their long-lasting persistence with the median Duration of Response
not reached, provides a strong foundation for the ongoing TACTI-003
trial in 1st line HNSCC. The combination of the MHC Class II
agonist, efti, with pembrolizumab is now showing an encouraging
overall survival benefit in two different cancer indications.”
As seen in multiple clinical trials, efti is
generating very durable responses when combined with anti-PD-(L)1
therapies. Notably, one of the five complete responses that lasted
28 months (as of the data cut-off) occurred in a patient with
negative PD-L1 expression or CPS <1.
The safety profile of efti in combination with
pembrolizumab continues to be safe and very well tolerated. No new
safety signals were observed from Part C of the TACTI-002 Phase II
trial. The dual immuno-oncology approach had adverse reactions that
led to treatment discontinuation in only two patients (5.1%)2,
which compares favorably to the treatment discontinuation rate from
adverse reactions with anti-PD-1 monotherapy in the same patient
population (6.1%).1
“It’s noteworthy to see efti combined with
pembrolizumab generating a response in 29.7% of patients with 2nd
line HNSCC, including five patients with complete responses,
regardless of PD-L1 expression. In patients expressing PD-L1 CPS
>1 or PD-L1 CPS >20, overall survival, progression-free
survival, and response rates from the dual immuno-oncology approach
compare rather favourably to reported results from anti-PD-1
monotherapy approved for the treatment of platinum refractory
metastatic HNSCC,” stated Frédéric Triebel, M.D., Ph.D., Immutep’s
CSO.
"These final results in 2nd line HNSCC are very
encouraging in a difficult to treat patient population. It was the
strength of interim results from TACTI-002, along with efti’s
potential to address an unmet medical need, that secured FDA Fast
Track designation for 1st line treatment of HNSCC. In 1st line
HNSCC, we are now focused on completing enrolment for TACTI-003 by
mid-year and expect to report top-line results later in H2 of
CY2023,” said Marc Voigt, Immutep’s CEO.
In addition to the abstract and information that
was announced to the ASX on 263 and 31 May 20234, the Final
results from TACTI-002 Part C: A Phase II study of eftilagimod
alpha (soluble LAG-3 protein) and pembrolizumab in patients with
metastatic 2nd line head and neck squamous cell carcinoma
unselected for PD-L1 poster will be available on the Posters
& Publication section of Immutep’s website following its
presentation between 2:15PM-5:15PM EDT at ASCO today.
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 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 Ezra E W Cohen et al., Pembrolizumab versus
methotrexate, docetaxel, or cetuximab for recurrent or metastatic
head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised,
open-label, phase 3 study; The Lancet 2019.
http://dx.doi.org/10.1016/S0140-6736(18)31999-82 Relationship to
efti and/or pembrolizumab could not be ruled out.3 Publication of
Abstracts for ASCO 2023 Annual Meeting 26 May 2023 4 Immutep
Capital Raising Presentation 31 May 2023 – slides 25 & 26
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