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Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the European Lung Cancer Congress 2025

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Immutep (NASDAQ: IMMP) has announced an upcoming poster presentation at the European Lung Cancer Congress (ELCC) 2025 in Paris, featuring their pivotal TACTI-004 Phase III trial. The trial evaluates eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy for first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC).

The global study will enroll approximately 750 patients across 150+ clinical sites in 25+ countries, including patients with non-squamous or squamous tumors regardless of PD-L1 expression. The poster presentation, numbered 131TiP, will be delivered by Dr. Margarita Majem on March 26, 2025, at 13:50 CET.

According to CSO Frédéric Triebel, the combination therapy could potentially transform treatment for advanced NSCLC patients, building on promising safety and efficacy data observed to date.

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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.

Australian Investors/Media:
Catherine Strong, Sodali & Co.
+61 (0)406 759 268; catherine.strong@sodali.com

U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com


FAQ

What is the size and scope of Immutep's TACTI-004 Phase III trial for NSCLC?

The trial will enroll 750 patients across 150+ clinical sites in over 25 countries, studying eftilagimod alfa with KEYTRUDA and chemotherapy for first-line NSCLC treatment.

When and where will Immutep (IMMP) present their TACTI-004 trial results?

The trial poster will be presented at the European Lung Cancer Congress in Paris on March 26, 2025, at 13:50 CET.

What patient population is eligible for Immutep's TACTI-004 NSCLC trial?

The trial accepts patients with advanced or metastatic non-small cell lung cancer, including both non-squamous and squamous tumors, regardless of PD-L1 expression.

What is the treatment combination being tested in IMMP's TACTI-004 trial?

The trial tests eftilagimod alfa (efti) in combination with KEYTRUDA (pembrolizumab) and chemotherapy as first-line therapy for NSCLC.

Who will present Immutep's TACTI-004 trial poster at ELCC 2025?

Dr. Margarita Majem from the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, will present the poster (number 131TiP).
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