Immutep (ASX:IMM) has passed a key clinical milestone, achieving 50 per cent patient enrolment in its pivotal global Phase 3 trial evaluating a novel immunotherapy combination for first-line non-small cell lung cancer (NSCLC).
The registrational TACTI-004 (KEYNOTE-F91) study has now enrolled 378 patients worldwide, marking the halfway point toward its target enrolment of approximately 756 patients. The trial is assessing Immutep's eftilagimod alfa (efti) in combination with MSD’s anti-PD-1 therapy KEYTRUDA and chemotherapy as an initial treatment for patients with advanced or metastatic NSCLC.
Enrollment has continued at a strong pace across a broad international footprint, with more than 140 clinical sites activated in 27 countries. Immutep remains on track to conduct a pre-planned futility analysis in the first quarter of calendar year 2026, while full patient enrolment is expected to be completed in the third quarter of the year.
Chief Executive Officer Marc Voigt said the progress reflects both the clinical promise of efti and the need for more effective first-line treatment options in lung cancer. He noted that the company is approaching several important milestones as it works to advance the therapy toward potential regulatory approval.
The TACTI-004 trial is designed to determine whether adding efti to standard pembrolizumab and chemotherapy improves outcomes by increasing the proportion of patients who respond to anti-PD-1 therapy, regardless of PD-L1 expression. If successful, the combination could establish a new standard of care in one of the largest and deadliest oncology indications.
Efti is a first-in-class MHC Class II agonist that activates antigen-presenting cells and stimulates both the innate and adaptive immune system. It is being evaluated across multiple solid tumour indications and has received Fast Track designation from the US Food and Drug Administration in first-line NSCLC and head and neck cancer, underscoring its potential clinical significance.