Immutep (ASX:IMM), a leader in lymphocyte activation gene-3 immunotherapy, has announced a significant operational breakthrough in its global TACTI-004 (KEYNOTE-F91) Phase 3 clinical trial.
The company has reached the 50% enrollment mark, having recruited 378 patients out of its total target.
The registrational study is evaluating the efficacy of Immutep’s flagship candidate, eftilagimod alfa, in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as a first-line treatment for advanced or metastatic non-small cell lung cancer.
The trial's rapid progress is a testament to the clinical interest in efti’s unique mechanism.
By combining efti with standard-of-care treatments, Immutep aims to improve patient response rates and survival across all PD-L1 expression levels—a critical need in one of oncology's most challenging indications.
Currently, the trial is active across 140 clinical sites in 27 countries, reflecting the massive scale of the global effort.
Immutep CEO Marc Voigt highlighted the "excellent pace" of the study, noting that the company remains on track for two pivotal milestones this year: the futility analysis in Q1 2026 and the completion of patient enrollment by Q3 2026.
If successful, this triple-combination therapy could redefine the standard of care for 1L NSCLC patients worldwide, offering a more efficacious alternative to current regimens.