Immutep Achieves 50% Enrolment in Global TACTI-004 (KEYNOTE-F91) Phase III Trial in 1L NSCLC
MWN-AI** Summary
Immutep Limited, an innovative biotech company focused on immunotherapy for cancer, has successfully reached the halfway mark in patient enrolment for its pivotal Phase III trial, TACTI-004 (KEYNOTE-F91), designed for first-line treatment of advanced or metastatic non-small cell lung cancer (1L NSCLC). As of February 6, 2026, the trial has recruited 378 participants globally, representing 50% of its target of 756 patients. This trial assesses the efficacy of eftilagimod alfa (efti) in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), and chemotherapy, aiming to improve clinical outcomes for patients regardless of their PD-L1 expression levels.
Marc Voigt, CEO of Immutep, highlighted the rapid enrolment pace as a testament to the potential of efti and the critical demand for effective therapies in the 1L NSCLC landscape. The study's design includes over 140 clinical sites across 27 countries, with a focus on finding a new standard of care for this prevalent and deadly cancer type.
The trial employs a dual primary endpoint strategy, aiming for enhanced progression-free survival and overall survival. Efti, recognized for its unique mechanism of activating antigen-presenting cells, has shown promise in mobilizing a comprehensive immune response against cancer, potentially expanding treatment options for patients.
Looking ahead, the company is poised for significant milestones, including the anticipated futility analysis in the first quarter and full enrolment projected to conclude in the third quarter of 2026. This trial represents a critical step in Immutep's mission to deliver novel treatments to the oncology market and leverage its expertise in developing therapies related to the Lymphocyte Activation Gene-3 (LAG-3) pathway.
MWN-AI** Analysis
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has recently achieved a significant milestone in its TACTI-004 (KEYNOTE-F91) Phase III trial for eftilagimod alfa (efti) in the treatment of first-line non-small cell lung cancer (1L NSCLC) by enrolling 50% of its target participants. This consists of 378 patients from a planned total of 756 and indicates a robust trajectory toward meeting its deadlines for full enrollment and futility analysis.
The promising enrolment pace, combined with the strategic partnership with MSD (Merck), highlights the potential of efti to establish a new standard of care in treating 1L NSCLC. This trial's design involves a robust methodology assessing both progression-free survival and overall survival, crucial endpoints for the oncology sector. The combination therapy is particularly noteworthy since it seeks to address a substantial population of NSCLC patients, irrespective of PD-L1 expression levels, thus broadening its applicability.
For investors, the successful progression of TACTI-004 positions Immutep favorably within the competitive oncology landscape. The potent combination of efti, KEYTRUDA, and chemotherapy could yield lucrative outcomes, especially given the high unmet need for effective treatments in NSCLC. Moreover, the FDA's Fast Track designation for efti adds an additional layer of optimism regarding the drug's regulatory pathway and potential for accelerated approval.
Given the large market opportunity and the therapeutic promise of the treatment, current shareholders may consider holding or adding to their positions in anticipation of positive trial outcomes and subsequent market entry. However, prudent investors should also assess risks associated with clinical trials in biotech, including data variability and regulatory hurdles. Continuous monitoring of trial progress and broader industry developments will be essential in determining the optimal investment strategy moving forward.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- The registrational TACTI-004 trial in first line non-small cell lung cancer (1L NSCLC) has enrolled 378 patients globally, 50% of the trial's targeted enrolment
- Futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively
SYDNEY, AUSTRALIA, Feb. 06, 2026 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces it has achieved 50% of the patient enrolment target 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 (1L NSCLC).
Immutep Chief Executive Officer, Marc Voigt, said, “The excellent pace of enrolment globally in the TACTI-004 trial speaks to the promise of efti and the need for more efficacious therapies in the first line setting for patients with advanced/metastatic non-small cell lung cancer. Our team continues to work hard to bring this innovative cancer immunotherapy to market and looks forward to delivering on additional important upcoming milestones ahead, including the futility analysis in the first quarter and completing patient enrolment in the third quarter this year.”
The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients’ survival.
The registrational TACTI-004 Phase III has enrolled 378 patients globally and enrolment continues its robust pace. Additionally, over 140 clinical sites are now activated across 27 countries. The futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About TACTI-004
TACTI-004 (Two ACTive Immunotherapies) 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; eleanor.pearson@sodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ**
How does Immutep Limited IMMP plan to leverage the results of the TACTI-004 trial to secure approvals for eftilagimod alfa in new markets beyond the United States?
What specific milestones does Immutep Limited IMMP aim to achieve in the TACTI-004 trial before the completion of patient enrolment in Q3 2026?
Given the promising enrolment rates in the TACTI-004 trial, what strategies is Immutep Limited IMMP employing to maintain this pace and enhance patient recruitment?
How could the success of the TACTI-004 trial impact Immutep Limited IMMP's overall strategy and growth in the competitive oncology market?
**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).
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