Immutep Announces Strong Operational Progress in Global TACTI-004 (KEYNOTE-F91) Phase III and Enrolment Continues at Robust Pace

Immutep (ASX:IMM; NASDAQ:IMMP) reports strong operational progress in the registrational TACTI-004 (KEYNOTE-F91) Phase III trial of eftilagimod alfa (efti) with KEYTRUDA and chemotherapy for first-line advanced/metastatic NSCLC.

Rhea-AI Summary

Immutep (ASX:IMM; NASDAQ:IMMP) reports strong operational progress in the registrational TACTI-004 (KEYNOTE-F91) Phase III trial of eftilagimod alfa (efti) with KEYTRUDA and chemotherapy for first-line advanced/metastatic NSCLC.

Key facts: 289 patients enrolled (≈38% of 756 target), >120 activated clinical sites, 27 countries with full regulatory approvals, futility analysis on track for Q1 CY2026, and expected completion of enrolment in Q3 CY2026. Licensing interest noted with a deal for emerging markets with Dr Reddy's.

Positive

• 289 patients enrolled (~38% of 756 target)
• >120 activated clinical sites globally
• 27 countries received full regulatory approvals
• Futility analysis on track for Q1 CY2026

Negative

• 62% of target (467 patients) still to enroll
• Futility analysis not yet completed (scheduled Q1 CY2026)
• Patient enrolment completion required by Q3 CY2026

Argus Dec 16 session

+2.05% close to close Open Argus

Details

News Market Reaction – IMMP

In the Dec 16 session, IMMP gained 2.05%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement underscores meaningful clinical execution, with TACTI-004 Phase III now at 289 of ...

Analysis

This announcement underscores meaningful clinical execution, with TACTI-004 Phase III now at 289 of 756 planned patients and more than 120 activated sites across 27 countries. It follows earlier disclosures that the futility threshold of 170 patients had been reached and FDA Project Optimus requirements met. Investors may focus on timing for the Q1 CY2026 futility analysis, enrolment completion in Q3 CY2026, and consistency of trial operations across geographies.

Key Figures

Patients enrolled: 289 patients Target enrolment: 756 patients Enrolment progress: over 38% +5 more

Patients enrolled

289 patients

TACTI-004 Phase III global enrolment

Target enrolment

756 patients

TACTI-004 Phase III trial target size

Enrolment progress

over 38%

Portion of TACTI-004 target enrolment reached

Activated sites

over 120 sites

TACTI-004 clinical sites globally

Countries approved

27 countries

Regulatory approvals for TACTI-004 including US

Futility threshold

170 patients

Enrolment required to conduct futility analysis

Futility analysis timing

Q1 CY2026

Planned timing for TACTI-004 futility analysis

Enrolment completion goal

Q3 CY2026

Expected completion of TACTI-004 patient enrolment

Historical Context

5 past events · Latest: Dec 08

5 events

1. Dec 08

   Licensing partnership

   24h Move

   +26.1%

   Exclusive efti licensing deal with Dr. Reddy’s and sizeable milestones.

2. Dec 02

   Clinical data update

   24h Move

   -7.1%

   Phase II AIPAC-003 breast cancer data with strong responses and immune activation.

3. Nov 13

   Clinical data update

   24h Move

   +2.8%

   EFTISARC-NEO Phase II sarcoma data meeting primary endpoint with strong pathology.

4. Nov 03

   Tax incentive cash

   24h Move

   -3.2%

   French R&D tax incentive cash inflow supporting ongoing clinical development.

5. Oct 29

   Quarterly update

   24h Move

   -1.0%

   Q1 FY26 report with TACTI-004 progress and cash of A$109.85M to end CY2026.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase iii, anti-pd-1 therapy, non-small cell lung cancer, futility analysis, +1 more

5 terms

phase iii medical

"The registrational TACTI-004 Phase III has enrolled 289 patients globally"

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

anti-pd-1 therapy medical

"eftilagimod alfa (efti) in combination with MSD’s anti-PD-1 therapy, KEYTRUDA"

Anti-PD-1 therapy are drugs that block the PD-1 protein on immune cells, effectively releasing the “brakes” that can prevent the body from attacking cancer cells; think of it like removing a safety lock so security guards can better recognize intruders. Investors care because these therapies can transform treatment outcomes, drive significant sales if approved for multiple cancers, and carry regulatory, patent and competitive risks that affect a company’s valuation.

non-small cell lung cancer medical

"as first line therapy for advanced/metastatic non-small cell lung cancer"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

futility analysis medical

"Futility analysis remains on track for the first quarter of CY2026"

A futility analysis is a planned mid-course check in a clinical trial to determine whether continuing the study is unlikely to show a meaningful benefit. Think of it like pausing a long road trip to see if you’re close enough to your destination to justify the remaining time and fuel; if not, the trial may be stopped early to limit costs and risk. For investors, futility results can sharply change a company’s timeline, spending needs and the likelihood of regulatory approval, which in turn affects valuation.

institutional review board (irb) regulatory

"receipt of local and central Institutional Review Board (IRB) approvals"

An institutional review board (IRB) is an independent committee that reviews and approves research involving people to make sure studies are safe, ethical, and that participants give informed consent. For investors, IRB approval is like a safety inspection for a company’s clinical program: it can reduce regulatory risk, affect how quickly trials start or proceed, and influence whether study results will be accepted by regulators, all of which can change a company’s value and outlook.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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 (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 many patients has Immutep (IMMP) enrolled in TACTI-004 as of Dec 16, 2025?

289 patients have been enrolled, about 38% of the 756-patient target.

When is the TACTI-004 futility analysis for IMMP scheduled?

The futility analysis is on track for Q1 CY2026.

When does Immutep expect to complete patient enrolment for TACTI-004 (IMMP)?

Immutep expects to complete enrolment in Q3 CY2026.

How many clinical sites and countries are activated for Immutep's TACTI-004 trial?

The trial has activated over 120 clinical sites and obtained approvals in 27 countries.

What proportion of TACTI-004 enrolment remains for IMMP to reach 756 patients?

Approximately 62% remains, equal to about 467 patients still to enroll.

Has Immutep announced any licensing deals related to efti ahead of TACTI-004 milestones?

Yes; the company noted a licensing deal for efti in emerging markets with Dr Reddy's.