Immutep Achieves 50% Enrolment in Global TACTI-004 (KEYNOTE-F91) Phase III Trial in 1L NSCLC

Rhea-AI Summary

Immutep (NASDAQ: IMMP) announced it has reached 50% enrolment in the registrational TACTI-004 (KEYNOTE-F91) Phase III trial for first-line advanced/metastatic non-small cell lung cancer. The trial has enrolled 378 patients, with >140 activated clinical sites across 27 countries.

Immutep says the futility analysis remains on track for Q1 CY2026 and patient enrolment completion is expected in Q3 CY2026.

Positive

• 50% enrolment achieved toward the trial target
• 378 patients enrolled globally to date
• 140+ clinical sites activated across 27 countries
• Futility analysis on track for Q1 CY2026 and enrolment completion targeted for Q3 CY2026

Negative

• None.

News Market Reaction – IMMP

%

1 alert

% News Effect

On the day this news was published, IMMP declined NaN%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients enrolled: 378 patients Enrolment progress: 50% of target Activated sites: over 140 sites +3 more

6 metrics

Patients enrolled 378 patients TACTI-004 Phase III 1L NSCLC trial

Enrolment progress 50% of target TACTI-004 registrational Phase III

Activated sites over 140 sites Global TACTI-004 trial footprint

Countries 27 countries TACTI-004 trial geographies

Futility analysis timing Q1 CY2026 Planned TACTI-004 interim analysis

Enrolment completion target Q3 CY2026 Planned completion of TACTI-004 enrolment

Market Reality Check

Price: $2.79 Vol: Volume 109,925 vs 20-day ...

low vol

$2.79 Last Close

Volume Volume 109,925 vs 20-day average 186,864 (relative volume 0.59) ahead of this update. low

Technical Shares at 2.62, trading above the 200-day MA of 2.00 before this news.

Peers on Argus

IMMP was down 2.96% pre-news while several biotech peers in its group (e.g., ACI...

1 Up

IMMP was down 2.96% pre-news while several biotech peers in its group (e.g., ACIU, CADL, FENC, HUMA) also showed single‑digit declines, but momentum data flagged only EDIT with a notable upside move of 6.31%, suggesting today’s IMMP news is stock-specific rather than part of a broad sector rotation.

Previous Clinical trial Reports

5 past events · Latest: Dec 22 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 22	IMP761 Phase I update	Positive	+4.9%	Positive Phase I IMP761 safety and PK/PD data in autoimmune diseases.
Dec 16	TACTI-004 progress	Positive	+2.0%	Operational progress with TACTI-004 Phase III and robust enrolment pace.
Dec 02	AIPAC-003 data	Positive	-7.1%	New AIPAC-003 Phase II breast cancer data with strong responses.
Nov 13	EFTISARC-NEO CTOS data	Positive	+2.8%	EFTISARC-NEO Phase II sarcoma data meeting primary endpoint with biomarker support.
Oct 20	EFTISARC-NEO endpoint	Positive	-1.4%	EFTISARC-NEO Phase II met primary endpoint and was presented at ESMO.

Pattern Detected

Recent clinical trial headlines produced mixed reactions, with 3 aligned and 2 divergent price moves.

Recent Company History

Over recent months, Immutep has issued multiple clinical trial updates across its LAG-3 pipeline. Positive Phase I data for IMP761, strong operational progress in the Phase III TACTI-004 NSCLC trial, new AIPAC-003 breast cancer data, and two successive EFTISARC-NEO soft tissue sarcoma readouts all underscored broad clinical activity. Share reactions have varied, with both gains and pullbacks following positive updates, framing today’s TACTI-004 enrolment milestone within an ongoing pattern of active development and mixed short-term trading responses.

Historical Comparison

+0.3% avg move · Across the last 5 clinical-trial updates, IMMP’s average 1-day move was only 0.25%, suggesting typic...

clinical trial

+0.3%

Average Historical Move clinical trial

Across the last 5 clinical-trial updates, IMMP’s average 1-day move was only 0.25%, suggesting typically modest reactions even to meaningful clinical milestones like today’s TACTI-004 enrolment update.

Recent clinical-trial news shows progression from Phase II sarcoma and breast cancer data to advancing IMP761 Phase I and operational milestones in the registrational TACTI-004 Phase III NSCLC program.

Market Pulse Summary

This announcement highlights a key operational milestone, with TACTI-004 reaching 378 enrolled patie...

Analysis

This announcement highlights a key operational milestone, with TACTI-004 reaching 378 enrolled patients, or 50% of target, across more than 140 sites in 27 countries. It reinforces steady execution toward a registrational Phase III readout in 1L NSCLC, with futility analysis planned for Q1 CY2026 and enrolment completion in Q3 CY2026. Investors may focus on these upcoming checkpoints and how they connect to prior positive LAG‑3 clinical data.

Key Terms

phase iii, non-small cell lung cancer, 1l nsclc, immunotherapy, +3 more

7 terms

phase iii medical

"TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa"

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.

non-small cell lung cancer medical

"first line non-small cell lung cancer (1L NSCLC) has enrolled 378 patients"

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.

1l nsclc medical

"as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC)."

1L NSCLC stands for first-line non-small cell lung cancer, meaning the initial treatment given to patients diagnosed with the most common type of lung cancer. It matters to investors because winning approval or gaining market share in first-line therapy is like capturing the biggest piece of the market at the start of a race: these treatments reach the largest group of patients, drive the fastest and most sustained sales, and shape future trial comparisons and licensing value.

immunotherapy medical

"a late-stage immunotherapy company targeting cancer and autoimmune diseases"

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

anti-pd-1 therapy medical

"MSD’s ... anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), and chemotherapy"

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.

pembrolizumab medical

"KEYTRUDA® (pembrolizumab), and chemotherapy as first line therapy"

A cancer immunotherapy drug that helps the body’s immune system recognize and attack tumor cells by blocking a molecular “brake” that tumors use to hide. Investors watch it because regulatory approvals, clinical trial results, dosing rules, and competition directly affect potential sales, profit forecasts, and the valuation of companies that sell or license the drug—think of trial outcomes as checkpoint signs that can open or close a revenue road.

futility analysis technical

"Futility analysis and completion of patient enrolment remain on track"

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.

AI-generated analysis. Not financial advice.

• 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

What milestone did Immutep (IMMP) announce for the TACTI-004 Phase III trial on February 6, 2026?

Immutep announced it has reached 50% of target enrolment in the TACTI-004 Phase III trial. According to the company, the study has enrolled 378 patients globally with continued site activations across 27 countries.

When is the futility analysis and final patient enrolment for Immutep's (IMMP) TACTI-004 trial expected?

The futility analysis is expected in Q1 CY2026 and enrolment completion in Q3 CY2026. According to the company, both milestones remain on track as the trial progresses toward full enrolment.

How broad is the TACTI-004 trial footprint for Immutep (IMMP) in terms of sites and countries?

The trial currently has over 140 activated clinical sites across 27 countries. According to the company, this global footprint supports continued rapid enrolment and diverse patient recruitment for the registrational study.

What treatment combination is being tested in Immutep's (IMMP) TACTI-004 Phase III first-line NSCLC trial?

TACTI-004 evaluates eftilagimod alfa (efti) with pembrolizumab and chemotherapy as first-line therapy for advanced/metastatic NSCLC. According to the company, the combination aims to expand responses to anti-PD-1 therapy across PD-L1 expression levels.