Immutep Hits 50% Enrolment in Pivotal Lung Cancer Trial
Immutep Limited has reached the halfway mark in enrolling patients for its global Phase III TACTI-004 trial, testing a novel immunotherapy combo in first-line non-small cell lung cancer. The trial remains on track for key milestones this year, signaling steady progress in a critical oncology space.
- 50% enrolment achieved in global Phase III TACTI-004 trial
- Trial evaluates eftilagimod alfa with KEYTRUDA and chemotherapy in 1L NSCLC
- Futility analysis expected in Q1 2026; enrolment completion targeted for Q3 2026
- Over 140 clinical sites activated across 27 countries
- Potential to establish new standard of care in advanced/metastatic NSCLC
Halfway Milestone in a Global Cancer Trial
Immutep Limited, a Sydney-based biotechnology company, has announced a significant enrolment milestone in its Phase III TACTI-004 trial, designed to evaluate a novel immunotherapy combination for advanced non-small cell lung cancer (NSCLC). The trial has now enrolled 378 patients globally, reaching 50% of its targeted 756-patient cohort. This progress underscores both the urgency and promise of new treatment options in one of the deadliest cancer types.
Innovative Combination Therapy Under Evaluation
The TACTI-004 study is testing eftilagimod alfa (efti), an MHC Class II agonist that activates the immune system’s antigen-presenting cells, in combination with Merck’s KEYTRUDA (pembrolizumab) and chemotherapy. This triple combination aims to boost the immune response against tumours, potentially improving outcomes for patients with advanced or metastatic NSCLC regardless of PD-L1 expression levels. If successful, it could redefine the first-line standard of care by expanding the number of patients who respond to anti-PD-1 therapies.
Global Reach and Trial Execution
The trial’s enrolment pace has been described as robust, with over 140 clinical sites activated across 27 countries. This extensive network highlights the global scale and collaborative effort behind the study. Immutep’s CEO, Marc Voigt, emphasised the team’s commitment to advancing this innovative therapy and expressed confidence in meeting upcoming milestones, including a futility analysis scheduled for the first quarter of 2026 and full enrolment by the third quarter.
Looking Ahead, What’s Next for Immutep?
While no interim efficacy data has been released yet, the trial’s design includes dual primary endpoints of progression-free survival and overall survival, critical measures for assessing clinical benefit in oncology. The coming months will be pivotal as the futility analysis will determine whether the trial should continue as planned. Success in this trial could position Immutep as a key player in the competitive NSCLC treatment landscape, potentially offering patients a more effective immunotherapy option.
Bottom Line?
With enrolment on track, all eyes now turn to the upcoming futility analysis that could shape Immutep’s future in lung cancer treatment.
Questions in the middle?
- Will the futility analysis confirm the trial’s potential to improve survival outcomes?
- How will Immutep position eftilagimod alfa against existing and emerging NSCLC therapies?
- What are the commercial implications if the combination therapy becomes a new standard of care?
