Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the European Lung Cancer Congress 2025
MWN-AI** Summary
Immutep Limited (ASX: IMM; NASDAQ: IMMP), a late-stage immunotherapy company focusing on cancer treatments, has announced the upcoming presentation of a pivotal Trial in Progress poster for its TACTI-004 Phase III trial at the European Lung Cancer Congress (ELCC) 2025. The event will take place in Paris from March 26-29, 2025.
The TACTI-004 trial evaluates Immutep’s proprietary MHC Class II agonist, eftilagimod alfa (efti), in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy from MSD, along with chemotherapy, aimed at first-line treatment for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). This global study plans to enroll approximately 750 participants across over 150 clinical sites in more than 25 countries, without regard to PD-L1 expression, including both non-squamous and squamous tumors.
Frédéric Triebel, Immutep’s Chief Scientific Officer, expressed anticipation for the opportunity to engage with the lung cancer community during the conference, emphasizing the potential of the combination therapy to transform treatment paradigms for NSCLC patients. The trial aims to substantiate promising safety and efficacy findings from previous studies.
The poster, identified with presentation number 131TiP, will be presented by Dr. Margarita Majem from the Hospital de la Santa Creu i Sant Pau on March 26, 2025, at 13:50 CET. Following the presentation, the poster will also be accessible on Immutep’s website in the Posters & Publications section.
Eftilagimod alfa is designed to stimulate both innate and adaptive immune responses, enhancing immune attack against cancers. It has shown promise across multiple solid tumors and holds Fast Track designation from the FDA for first-line treatment in HNSCC and NSCLC.
MWN-AI** Analysis
As Immutep Limited (ASX: IMM; NASDAQ: IMMP) prepares to present the pivotal TACTI-004 trial at the European Lung Cancer Congress (ELCC) 2025, investors should closely monitor developments given the study's potential impact on the company's valuation and future revenue streams. The TACTI-004 Phase III trial explores the efficacy of eftilagimod alfa (efti)—a novel MHC Class II agonist—combined with Merck’s KEYTRUDA® and chemotherapy for treating advanced or metastatic non-small cell lung cancer (NSCLC).
The enrollment of approximately 750 patients across over 150 sites globally signifies a robust commitment to exploring efti’s therapeutic benefits across diverse cohorts. A key element to note is that the trial aims to include patients regardless of PD-L1 expression, which could broaden the drug's applicability and market potential in a field crowded with competitive therapies, particularly in the context of personalized medicine trends.
Dr. Frédéric Triebel's insights on the trial's promise underscore the anticipated shift in treatment paradigms. Should efti demonstrate superior efficacy and safety, it may not only solidify Immutep's status within the oncology space but also open doors for regulatory accolades and commercial partnerships that enhance liquidity and investment appeal.
Investors are advised to stay vigilant for updates post-ELCC presentation, particularly for early clinical indicators or data releases that may arise from the trial. Given Immutep’s favorable safety profile and Fast Track designations with the FDA, there’s substantial potential for upward stock momentum, provided the forthcoming data meets or exceeds market expectations.
In summary, Immutep presents an intriguing opportunity for those seeking exposure within the biotech sector, especially as it targets a significant therapeutic area with unmet needs. Investors should evaluate not just the trial outcomes, but also the strategic implications for larger market positioning and potential collaborations.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news 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-? 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**
How does the pivotal TACTI-004 Phase III trial for Immutep Limited IMMP address the unmet needs in the treatment of advanced non-small cell lung cancer compared to existing therapies?
What are the expected outcomes for patient enrollment in Immutep Limited IMMP's TACTI-004 trial, particularly regarding diversity in PD-L1 expression and tumor types?
Can you elaborate on the safety profile of eftilagimod alfa (efti) in the context of the TACTI-004 trial, especially when combined with KEYTRUDA and chemotherapy?
What strategic partnerships or collaborations are in place to support the global expansion of Immutep Limited IMMP's clinical trials for eftilagimod alfa (efti)?
**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).
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