Immutep Limited announces a poster presentation on the TACTI-004 Phase III trial at the European Lung Cancer Congress 2025.
Quiver AI Summary
Immutep Limited announced an upcoming poster presentation for its pivotal TACTI-004 Phase III trial at the European Lung Cancer Congress in Paris from March 26-29, 2025. The trial evaluates Immutep’s MHC Class II agonist, eftilagimod alfa (efti), in combination with Merck’s KEYTRUDA® and chemotherapy for first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC). The global trial aims to enroll around 750 patients across more than 150 clinical sites in over 25 countries, regardless of PD-L1 expression. Immutep's CSO, Frédéric Triebel, expressed optimism about the potential of this combination to alter treatment protocols for this patient group. The poster presentation will highlight the trial's study design and progress, and will be accessible on Immutep's website afterward.
Potential Positives
- Immutep is set to present significant findings regarding their pivotal TACTI-004 Phase III trial at the European Lung Cancer Congress, which could attract attention within the oncology community.
- The trial evaluates the combination of Immutep's eftilagimod alfa and Merck's KEYTRUDA, indicating a potential shift in treatment paradigms for advanced/metastatic non-small cell lung cancer.
- The study has a broad global reach, with approximately 750 patients being recruited across over 150 clinical sites in more than 25 countries, highlighting its extensive scope and potential impact.
- Eftilagimod alfa has received Fast Track designation from the FDA for first-line NSCLC and HNSCC, signaling regulatory support and possibly expediting its development timeline.
Potential Negatives
- The announcement relies heavily on preliminary data from a trial that is still ongoing, which may lead to skepticism about the efficacy of the product until final results are released.
- The company might face challenges in the competitive landscape of cancer therapies, particularly with established therapies like KEYTRUDA, leading to potential market share concerns.
- Immutep's reliance on a collaboration with MSD for a combination therapy raises concerns about dependency on external partners for success and potential failures in that collaboration.
FAQ
What is the TACTI-004 Phase III trial about?
The TACTI-004 trial evaluates eftilagimod alfa in combination with KEYTRUDA and chemotherapy for advanced non-small cell lung cancer.
When will the TACTI-004 trial poster be presented?
The poster will be presented on 26 March 2025 at the European Lung Cancer Congress in Paris.
How many patients will the TACTI-004 trial enroll?
About 750 patients will be enrolled in the TACTI-004 trial across over 150 clinical sites worldwide.
What is eftilagimod alfa (efti) used for?
Efti is an immunotherapy used to enhance the immune response in various cancers, including non-small cell lung cancer.
Who is presenting the TACTI-004 poster?
The poster will be presented by Margarita Majem, MD, PhD, from the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
SYDNEY, AUSTRALIA, March 20, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces an upcoming poster presentation for the pivotal TACTI-004 Phase III trial. The poster will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place in Paris, France, from 26-29 March 2025.
The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s MHC Class II agonist, eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA® (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.
Immutep CSO, Frédéric Triebel, M.D., Ph.D, said, “We look forward to engaging with physicians in the lung cancer community at the ELCC conference to discuss our TACTI-004 Phase III study that is actively recruiting patients. Efti in combination with KEYTRUDA may change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression, and we hope to see this registrational trial confirm the promising safety and efficacy achieved to date.”
Details for the poster presentation:
Title
:
TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C
Presentation number
: 131TiP
Presenter
: Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau
Session Date and Time
: 26 March 2025, 13:50 CET
The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.
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 first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).
About Immutep
Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s 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
.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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