Immutep Announces Strong Operational Progress in Global TACTI-004 (KEYNOTE-F91) Phase III and Enrolment Continues at Robust Pace
MWN-AI** Summary
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has reported substantial operational advancement in its TACTI-004 (KEYNOTE-F91) Phase III trial, which evaluates the immunotherapy eftilagimod alfa (efti) in conjunction with MSD’s KEYTRUDA® (pembrolizumab) and chemotherapy for treating advanced or metastatic non-small cell lung cancer (NSCLC). The trial has successfully enrolled 289 patients globally, which represents over 38% of its goal of 756 total participants. This progress is complemented by the activation of over 120 clinical sites across 27 countries, including full regulatory approvals in the United States following the FDA's Project Optimus.
The timeline for the trial is promising, with a futility analysis scheduled for the first quarter of calendar year 2026 and patient enrolment expected to wrap up by the third quarter of that year. Immutep’s CEO, Marc Voigt, expressed confidence in the ongoing enthusiasm surrounding the trial, which has been further stimulated by a recent licensing deal for efti in emerging markets with Dr Reddy’s.
TACTI-004 is a randomized, double-blind, controlled study, focusing on patients without specific genetic aberrations. Participants are randomized to receive either the experimental treatment with efti, pembrolizumab, and chemotherapy, or a control group receiving pembrolizumab with chemotherapy and placebo. The trial's primary endpoints target progression-free survival and overall survival.
Eftilagimod is designed to activate antigen-presenting cells via the MHC Class II pathway, potentially enhancing the immune response against cancer. This novel treatment is also under investigation for various other cancers, highlighting Immutep's role as a pioneer in advancing LAG-3 therapeutics. The company remains dedicated to providing innovative treatment options and maximizing shareholder value through its ongoing efforts in cancer immunotherapy.
MWN-AI** Analysis
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has demonstrated commendable operational progress in its TACTI-004 Phase III clinical trial targeting advanced non-small cell lung cancer (NSCLC). With 289 patients already enrolled—over 38% of the targeted 756—Immutep appears to be on track for strong momentum as recruitment continues globally at an impressive rate.
The trial’s complexity is highlighted by its dual primary endpoints of progression-free survival and overall survival, and the successful activation of over 120 clinical sites across 27 countries, including critical markets such as the U.S. This broad regulatory approval adds credibility and potential for a swift market entry should results prove favorable.
Investor sentiment could be positively influenced with the upcoming futility analysis anticipated in Q1 2026, aligning with the company’s operational strategy to mitigate risk. The completion of patient enrollment targeted for Q3 2026 further strengthens potential timelines for results and subsequent regulatory discussions.
Eftilagimod alfa (efti), the subject of the trial, stands at the forefront of Immutep’s portfolio, representing a novel approach to cancer immunotherapy through MHC Class II engagement. Given its promising safety profile and recent licensing for emerging markets, Immutep's prospects for commercialization could improve significantly, thus enhancing shareholder value.
However, while the current outlook is robust, investors should remain vigilant given the inherent risks associated with clinical trials, including regulatory approvals and market competitiveness. As the trial phases progress, maintaining a close watch on recruitment levels and preliminary results will be crucial. Current stakeholders may consider holding positions to capitalize on anticipated uplifts in valuation once definitive outcomes are achieved in the pivotal TACTI-004 study.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- The registrational TACTI-004 Phase III has enrolled 289 patients globally, over 38% of the trial’s targeted enrolment
- Strong operational progress continues globally with over 120 activated clinical sites and 27 countries having received full regulatory approvals including the United States
- Futility analysis remains on track for the first quarter of CY2026 and completion of patient enrolment in the third quarter of CY2026
SYDNEY, AUSTRALIA, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today reports strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer.
The registrational TACTI-004 trial has enrolled 289 patients (over 38% of the trial’s targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites now exceeds 120 and 27 countries have received full regulatory approvals.
This includes the United States where the first of multiple clinical sites has received full regulatory clearance following the recent completion of the FDA’s Project Optimus initiative and subsequent receipt of local and central Institutional Review Board (IRB) approvals.
As announced on 9 October 2025, TACTI-004 had enrolled the necessary 170 patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Furthermore, Immutep expects to complete patient enrolment in the third quarter of CY2026.
Immutep Chief Executive Officer, Marc Voigt, said, “We are very pleased with the strong operational progress of TACTI-004 globally and the robust pace of recruitment. Growing interest in this pivotal trial has been enhanced by the recent licensing deal for efti in emerging markets with Dr Reddy’s. The Immutep team is excited about further delivering on key milestones ahead, including the futility analysis and completion of patient enrolment.”
KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About TACTI-004
TACTI-004 ( T wo ACT ive I mmunotherapies) is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations. The global trial will enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Patients will be randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study’s dual primary endpoints are progression-free survival and overall survival.
About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, 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 .
Australian Investors/Media:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; [email protected]
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; [email protected]
FAQ**
How does Immutep Limited (ASX: IMM; NASDAQ: IMMP) plan to maintain the current robust pace of patient enrollment in the TACTI-004 trial as it approaches the completion target in the third quarter of CY2026?
What potential impact could the results of the futility analysis scheduled for the first quarter of CY20have on the strategic direction of Immutep Limited (IMMP) and the TACTI-004 trial?
Given the recent licensing deal with Dr. Reddy’s, how does Immutep Limited (IMMP) envision this partnership influencing the global interest and recruitment process for the TACTI-004 trial?
Can you elaborate on the key differences between the treatment arm and the control arm in the TACTI-004 trial and how they reflect Immutep Limited’s (ASX: IMM; NASDAQ: IMMP) commitment to innovative cancer therapies?
**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).
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