Immutep (ASX:IMM) has dosed the first patient in its pivotal Phase III trial evaluating eftilagimod alfa (efti) for the treatment of advanced non-small cell lung cancer (NSCLC), marking a major milestone in its clinical program.
The trial, named TACTI-004, will assess efti in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy. The first patient was treated at Calvary Mater Newcastle Hospital in Australia.
The global, randomised, double-blind study will enrol around 756 patients across more than 150 clinical sites in over 25 countries. It is designed for first-line treatment of patients with advanced or metastatic NSCLC lacking EGFR, ALK, or ROS1 genomic aberrations. Patients will receive either the efti combination or KEYTRUDA and chemotherapy with a placebo. Dual primary endpoints are overall survival and progression-free survival.
Eftilagimod alfa is a first-in-class MHC Class II agonist designed to stimulate the immune system. Unlike checkpoint inhibitors that remove immune brakes, efti acts as an accelerator to trigger T-cell activation. Previous trials combining efti with KEYTRUDA have shown encouraging efficacy and safety across all PD-L1 expression levels.
Immutep’s Chief Executive Officer, Marc Voigt, said the first dosing marked one of the most important milestones in the company’s history. “If successful, the study will result in a clinically meaningful and statistically improved survival benefit and thus could potentially be practice changing,” he said.
Chief Scientific Officer Frédéric Triebel noted that the trial is using a 30mg subcutaneous dose of efti, consistent with prior studies and regulatory feedback. The dose is intended to balance immune activation with safety. “This novel approach has an excellent safety profile while delivering strong efficacy that compares favourably to standard-of-care therapies,” Triebel said.
Recruitment is underway across a growing list of countries with regulatory approval, including Australia, Germany, Canada, India, and the UK. Additional approvals are expected soon.
Lung cancer remains the deadliest cancer globally, with cases expected to rise to 3 million per year by 2030. NSCLC accounts for 80–85% of diagnoses and is frequently detected at a late stage. Less than 30% of patients are alive five years after diagnosis, highlighting the ongoing need for better therapies.
Immutep is a Sydney-based biotechnology company developing immunotherapies for cancer and autoimmune diseases, with a focus on LAG-3 biology.
