289 Patients Enrolled in Immutep’s Pivotal Phase III NSCLC Study
Immutep Limited reports robust progress in its pivotal Phase III TACTI-004 trial for advanced non-small cell lung cancer, with over 120 clinical sites activated across 27 countries including the US. Patient enrolment has reached 38% of the target, keeping key milestones on track.
- 289 patients enrolled globally, 38% of target
- Over 120 clinical sites activated in 27 countries
- First US clinical sites approved post-FDA Project Optimus
- Futility analysis scheduled for Q1 2026
- Patient enrolment expected to complete by Q3 2026
Global Momentum in TACTI-004 Trial
Immutep Limited has announced significant operational progress in its global Phase III TACTI-004 trial, evaluating the novel immunotherapy eftilagimod alfa (efti) in combination with Merck's KEYTRUDA and chemotherapy for first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC). The trial has enrolled 289 patients worldwide, representing over 38% of the targeted 756 participants, underscoring a robust recruitment pace.
With more than 120 clinical sites activated across 27 countries, including the United States, the trial's geographic reach is extensive. The US sites have recently received full regulatory approvals following the FDA's Project Optimus initiative and Institutional Review Board clearances, marking a critical milestone for the study's global footprint.
Strategic Importance of the Trial
TACTI-004 is a pivotal, registrational Phase III study designed to assess the efficacy and safety of efti combined with KEYTRUDA and chemotherapy versus KEYTRUDA and chemotherapy alone. The dual primary endpoints focus on progression-free survival and overall survival, key metrics that will determine the therapy's potential regulatory approval and commercial viability.
Eftilagimod alfa is a first-in-class MHC Class II agonist that activates antigen-presenting cells to stimulate a broad immune response against cancer. Its innovative mechanism complements anti-PD-1 therapies like KEYTRUDA, potentially enhancing treatment outcomes for patients with NSCLC who lack certain genomic tumor aberrations.
Looking Ahead – Milestones and Market Implications
Immutep expects to conduct a futility analysis in the first quarter of 2026, a critical checkpoint to evaluate whether the trial should continue based on interim data. Full patient enrolment is anticipated by the third quarter of 2026, setting the stage for subsequent data readouts that could influence regulatory decisions and market positioning.
CEO Marc Voigt highlighted the growing interest in the trial, boosted by a recent licensing agreement with Dr Reddy's Laboratories for emerging markets. This deal not only expands Immutep's commercial reach but also signals confidence in efti's potential as a new standard of care in NSCLC.
As the trial progresses, the biotech sector and investors will be watching closely to see if efti can deliver on its promise to enhance immunotherapy outcomes in a highly competitive oncology landscape.
Bottom Line?
With enrolment momentum and regulatory approvals in place, Immutep's TACTI-004 trial is poised for critical milestones that could reshape NSCLC treatment.
Questions in the middle?
- Will the upcoming futility analysis confirm the trial’s viability?
- How will the licensing deal with Dr Reddy’s impact Immutep’s global commercial strategy?
- What competitive advantages might efti offer over existing immunotherapies in NSCLC?
