Immutep (NASDAQ: IMMP) reaches 50% enrollment in Phase III lung cancer trial
Rhea-AI Filing Summary
Immutep Limited reported that it has reached 50% of the planned patient enrolment in its global TACTI-004 (KEYNOTE-F91) Phase III trial in first-line advanced or metastatic non-small cell lung cancer. The study evaluates eftilagimod alfa (efti) combined with KEYTRUDA (pembrolizumab) and chemotherapy versus KEYTRUDA, chemotherapy and placebo.
The registrational trial has enrolled 378 patients worldwide and plans to enrol approximately 756 patients across more than 150 clinical sites in over 25 countries. A futility analysis is planned for the first quarter of 2026, with completion of patient enrolment targeted for the third quarter of 2026.
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Insights
Immutep’s lead Phase III lung cancer trial has reached mid-enrolment with clear timelines for key 2026 milestones.
Immutep has enrolled 378 of approximately 756 planned patients in its global TACTI-004 Phase III trial in first-line non-small cell lung cancer. The study tests eftilagimod alfa with KEYTRUDA and chemotherapy against KEYTRUDA, chemotherapy and placebo, using progression-free and overall survival as dual primary endpoints.
The trial is described as registrational, spans over 140 clinical sites in 27 countries, and targets patients regardless of PD-L1 status and without EGFR, ALK, or ROS1 aberrations. The combination aims to increase responses to anti-PD-1 therapy across PD-L1 expression levels, which would be meaningful if the endpoints are met.
A futility analysis is scheduled for the first quarter of
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date as February 06, 2026
Commission File Number 001-35428
IMMUTEP LIMITED
(Exact Name as Specified in its Charter)
N/A
(Translation of Registrant’s Name)
Level 32, Australia Square
264 George Street, Sydney
NSW 2000, Australia
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☒
If “Yes” is marked, indicated below the file number assigned to the registrant in connection with Rule 12g3-2(b): Not applicable.
EXHIBIT INDEX
| Exhibit |
Description of Exhibit | |
| 99.1 |
Immutep Achieves 50% Enrolment in Global TACTI-004 (KEYNOTE-F91) Phase III Trial in 1L NSCLC | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: February 06, 2026
| IMMUTEP LIMITED | ||
| By: | /s/ Marc Voigt | |
| Name: | Marc Voigt | |
| Title: | Chief Executive Officer | |
Exhibit 99.1
Immutep Achieves 50% Enrolment in Global TACTI-004 (KEYNOTE-F91) Phase III Trial in 1L NSCLC
| • | 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 – February 06, 2026 – 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
This announcement was authorised for release by the CEO of Immutep Limited.
FAQ
What did Immutep (IMMP) announce in this Form 6-K filing?
Immutep announced it has reached 50% of its patient enrolment target in the global Phase III TACTI-004 (KEYNOTE-F91) trial in first-line non-small cell lung cancer. The study evaluates eftilagimod alfa in combination with KEYTRUDA and chemotherapy versus KEYTRUDA, chemotherapy and placebo.
How many patients are enrolled in Immutep’s TACTI-004 Phase III trial and what is the target?
The TACTI-004 trial has enrolled 378 patients globally toward a planned total of approximately 756 patients. This registrational study is designed to assess eftilagimod alfa plus KEYTRUDA and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.
What are the key upcoming milestones for Immutep’s TACTI-004 (KEYNOTE-F91) lung cancer trial?
Key milestones include a futility analysis planned for the first quarter of 2026 and completion of patient enrolment expected in the third quarter of 2026. These steps will help determine whether the Phase III study should continue as designed toward its primary endpoints.
What is being tested in Immutep’s TACTI-004 Phase III trial for first-line NSCLC?
The trial is evaluating eftilagimod alfa, an MHC Class II agonist immunotherapy, combined with KEYTRUDA and chemotherapy against a control arm of KEYTRUDA, chemotherapy and placebo. It targets patients with advanced or metastatic non-small cell lung cancer without EGFR, ALK, or ROS1 tumour aberrations.
What are the primary endpoints and design of the TACTI-004 (KEYNOTE-F91) study by Immutep?
TACTI-004 is a randomised, double-blind, controlled Phase III study with dual primary endpoints of progression-free survival and overall survival. Patients are randomised 1:1 to receive either eftilagimod alfa plus KEYTRUDA and chemotherapy or KEYTRUDA, chemotherapy and placebo across more than 25 countries.
What regulatory designations and broader development plans does Immutep have for eftilagimod alfa?
Eftilagimod alfa has received Fast Track designation from the U.S. FDA in first-line head and neck squamous cell carcinoma and first-line non-small cell lung cancer. It is being evaluated in multiple solid tumours, including NSCLC, HNSCC, soft tissue sarcoma and breast cancer in various clinical studies.
Filing Exhibits & Attachments
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