Immutep Limited (ASX: IMM) has enrolled 378 patients in its registrational TACTI-004 Phase III trial, representing 50% of the 756-patient target for the Immutep TACTI-004 trial enrolment. The trial evaluates eftilagimod alfa (efti) combined with MSD’s KEYTRUDA and chemotherapy as first-line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC).
Immutep hits halfway mark in pivotal lung cancer trial
The Immutep TACTI-004 trial enrolment milestone signals strong momentum in the company’s most advanced clinical programme. With 378 patients now enrolled across more than 140 clinical sites in 27 countries, the trial has reached its halfway point. This registrational Phase III study represents the final stage before potential FDA approval, positioning efti as a potential new standard of care in one of oncology’s largest indications.
The global trial targets approximately 756 patients regardless of PD-L1 expression levels, including both squamous and non-squamous tumours. Patients are randomised 1:1 to receive either efti in combination with pembrolizumab (KEYTRUDA) and chemotherapy, or pembrolizumab with chemotherapy and placebo. The study’s dual primary endpoints are progression-free survival (PFS) and overall survival (OS).
The enrolment pace directly impacts the timeline to potential commercialisation. Reaching 50% demonstrates strong investigator and patient interest in the therapy, with site activation continuing across multiple continents.
What is eftilagimod alfa and why does it matter?
Efti is a first-in-class MHC Class II agonist that activates the immune system through a different mechanism than existing cancer immunotherapies. Rather than targeting T cells directly, efti activates antigen-presenting cells (APCs) such as dendritic cells and monocytes. These APCs engage both the adaptive and innate immune systems to initiate a broad anti-cancer immune response.
Current immunotherapies work well for some lung cancer patients but fail to benefit others. Efti aims to expand the number of patients who respond to anti-PD-1 therapy across all PD-L1 expression levels. By activating APCs, efti primes and activates cytotoxic T cells while generating co-stimulatory signals and cytokines that further boost the immune system’s ability to combat cancer.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to efti in both first-line NSCLC and first-line head and neck squamous cell carcinoma (HNSCC). This designation recognises the therapy’s potential to address an unmet medical need.
Key milestones on the horizon
Two critical catalysts are approaching for the TACTI-004 trial:
- Futility analysis — Q1 CY2026
- Full enrolment completion — Q3 CY2026
The futility analysis represents a significant de-risking event for investors. This interim assessment evaluates whether the trial is likely to meet its efficacy endpoints. Passing the futility analysis signals the trial is on track and strengthens confidence in eventual success. Completion of enrolment in Q3 locks in the timeline toward the final data readout.
Both milestones remain on track according to the company’s 6 February 2026 announcement, with enrolment continuing at a robust pace across the activated clinical sites.
The 1L NSCLC market opportunity
Non-small cell lung cancer represents one of the largest and deadliest cancer indications globally. KEYTRUDA is already a market-leading therapy generating billions in annual revenue for MSD. The TACTI-004 trial positions efti as a potential enhancement to the current standard of care, aiming to expand response rates and improve clinical outcomes across the full patient population.
The trial design includes patients regardless of PD-L1 expression levels, with both squamous and non-squamous tumours eligible. This broad inclusion criteria maximises the potential addressable market for efti if approved.
| Trial Element | Detail |
|---|---|
| Patients Targeted | 756 |
| Randomisation | 1:1 |
| Treatment Arm | Efti + KEYTRUDA + chemotherapy |
| Control Arm | Placebo + KEYTRUDA + chemotherapy |
| Primary Endpoints | Progression-free survival (PFS) and overall survival (OS) |
The combination of a validated blockbuster therapy (KEYTRUDA) with efti positions Immutep (ASX: IMM) to potentially capture significant market share in a multi-billion dollar indication. Success in TACTI-004 could establish a new standard of care in 1L NSCLC.
CEO commentary
Management has expressed confidence in the trial’s progress and upcoming milestones.
Marc Voigt, Chief Executive Officer
“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 CEO’s remarks reinforce confidence in timeline delivery and clinical differentiation. The emphasis on “more efficacious therapies” highlights the unmet medical need efti aims to address.
What investors should watch next
Near-term catalysts include the futility analysis expected in Q1 CY2026 and full enrolment completion targeted for Q3 CY2026. These milestones will provide critical updates on the trial’s progress and likelihood of success.
Beyond NSCLC, efti is under evaluation across multiple solid tumour indications:
- Non-small cell lung cancer (NSCLC) — Phase III (TACTI-004)
- Head and neck squamous cell carcinoma (HNSCC) — with FDA Fast Track designation
- Soft tissue sarcoma
- Breast cancer
Efti’s favourable safety profile enables various combination approaches with anti-PD-(L)1 immunotherapy, radiotherapy, and chemotherapy. Positive TACTI-004 data could de-risk other indications using the same mechanism of action. Pipeline diversification provides multiple shots on goal for Immutep’s MHC Class II agonist platform, with each indication representing a distinct commercial opportunity.
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