Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the 2025 World Conference on Lung Cancer
MWN-AI** Summary
Immutep Limited (ASX: IMM; NASDAQ: IMMP), a prominent player in immunotherapy for cancer and autoimmune diseases, is set to present a poster detailing the pivotal TACTI-004 Phase III trial during the IASLC 2025 World Conference on Lung Cancer (WCLC) from September 6-9, 2025, in Barcelona, Spain. This trial is designed to evaluate Immutep’s proprietary compound, eftilagimod alfa (efti), in conjunction with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), and chemotherapy as a first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC).
The TACTI-004 trial aims to enroll about 750 patients globally, without restrictions based on PD-L1 expression levels, and will be conducted across more than 150 clinical sites in over 25 countries. Fundamental to this research is the belief that efti, as an APC activator, fosters both innate and adaptive immune responses, enhancing the efficacy of conventional immunotherapies. The trial findings will potentially impact treatment paradigms for NSCLC patients.
Immutep’s Chief Medical Officer, Dr. Stephan Winckels, has highlighted positive feedback received from the medical community regarding efti's favorable safety profile and ease of administration based on preliminary data from previous trials. The upcoming poster presentation, titled “TACTI-004, a Phase 3 trial of Eftilagimod Alfa plus Pembrolizumab and Chemotherapy vs Placebo plus Pembrolizumab and Chemotherapy in 1st line NSCLC,” will be presented by Dr. Martin Sebastian from the University Hospital of Frankfurt.
Following the WCLC presentation, the poster will be accessible on Immutep’s website, reflecting the company’s commitment to transparency and ongoing dialogue with the medical community concerning advancements in cancer treatment.
MWN-AI** Analysis
As Immutep Limited prepares to present the pivotal TACTI-004 trial results at the 2025 World Conference on Lung Cancer, investors should closely monitor developments stemming from the Phase III study of eftilagimod alfa (efti) in combination with Merck's KEYTRUDA® and chemotherapy. This trial represents a critical milestone for Immutep's growth strategy and its broader ambition to change the treatment landscape for non-small cell lung cancer (NSCLC).
Efti’s unique mechanism of action as an antigen presenting cell (APC) activator positions it well in an increasingly competitive landscape for immunotherapies. The trial's design allows for the enrollment of approximately 750 patients across various PD-L1 expression levels, which maximizes potential market reach. The initial feedback from physician engagements at significant oncology conferences, such as ELCC and ASCO, indicates strong interest in efti, highlighting its perceived efficacy and safety.
Investors should evaluate the implications of TACTI-004’s design. If positive, the trial could lead to accelerated approval pathways and strengthen Immutep's market position. The receipt of Fast Track designation by the FDA for efti in both NSCLC and HNSCC is encouraging, suggesting a favorable regulatory trajectory.
Moreover, consider the broader market context: with increasing focus on immunotherapies for solid tumors and escalating competition, successful trial outcomes could attract significant attention from institutional investors and potential partnerships. Carefully monitoring announcement timelines, analyst consensus following the WCLC presentation, and any shifts in analyst ratings post-trial data will be essential.
In conclusion, Immutep appears well-positioned for potential growth driven by the TACTI-004 trial outcomes. Investors should adopt a proactive approach, staying informed and prepared to adjust positions in response to the trial's findings, which could significantly impact Immutep's trajectory in the oncology landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SYDNEY, AUSTRALIA, July 29, 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 (KEYNOTE-F91) Phase III trial at the IASLC 2025 World Conference on Lung Cancer (WCLC), taking place in Barcelona, Spain, from 6-9 September 2025.
The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s antigen presenting cell (APC) activator, 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 (Tumour Proportion Score or TPS of 0-100%) and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.
Immutep CMO, Stephan Winckels M.D., Ph.D, said, “Our engagement to date with physicians in the lung cancer community, including at ELCC in Paris and ASCO in Chicago, has yielded encouraging feedback with a shared view of efti as a safe, easy-to-administer immunotherapy with strong efficacy across two 1L NSCLC trials. We look forward to continuing our investigator discussions at WCLC and ESMO around the pivotal TACTI-004 Phase III, which has the potential to change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression.”
Details for the poster presentation:
Title : TACTI-004, a Phase 3 trial of Eftilagimod Alfa plus Pembrolizumab (P) + Chemotherapy (C) vs Placebo + P + C in 1st line NSCLC
Presenter : Dr. Martin Sebastian, University Hospital of Frankfurt, Germany
Session : Clinical Trials in Progress
Date and Time : Tuesday, 9 September 2025 at 10:00 AM CEST
The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.
About Eftilagimod Alfa (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:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; eleanor.pearson@sodali.com
U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ**
What are the expected outcomes and potential market impact of the TACTI-004 Phase III trial results for Immutep Limited IMMP and its proprietary drug, eftilagimod alfa, in treating advanced non-small cell lung cancer?
How do the clinical feedback and preliminary efficacy results from the TACTI-004 trial position Immutep Limited IMMP compared to other competitors in the immunotherapy space for lung cancer?
What strategies does Immutep Limited IMMP plan to implement to maximize investor confidence and attract further funding post the WCLC presentation of the TACTI-004 trial results?
How do collaborations with MSD for the TACTI-004 trial enhance Immutep Limited IMMP's credibility and market reach in the competitive field of cancer immunotherapy?
**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).
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