Immutep Doses First Patient in Pivotal Phase III Lung Cancer Trial

Immutep (ASX: IMM; NASDAQ: IMMP) has taken a major step forward in its pursuit of a groundbreaking lung cancer treatment, dosing the first patient in its Phase III TACTI-004 trial.

The major study, which is being conducted at over 150 clinical sites worldwide, will assess the efficacy of Immutep’s eftilagimod alfa (efti) in combination with Merck’s blockbuster immunotherapy, Keytruda, and chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC).

The global trial will enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries

The first patient was treated at Calvary Mater Newcastle Hospital in Australia, marking a significant milestone in what could become a practice-changing development for NSCLC treatment. "Despite advancements in the treatment landscape for non-small cell lung cancer, there remains a high unmet need for new approaches that can safely extend patients’ lives," said Dr. Ina Nordman, the treating physician. "We hope to see this study confirm the promise of this novel combination to provide patients with a powerful new treatment option.”

Trial Design

Immutep’s TACTI-004 trial is designed to enroll approximately 756 patients in over 25 countries, evaluating efti—a novel MHC Class II agonist that enhances the immune system’s anti-cancer response—alongside Keytruda, a leading PD-1 checkpoint inhibitor. The company believes the combination could improve outcomes across all PD-L1 expression levels while maintaining a favourable safety profile.

The company has opted for a 30 mg subcutaneous dose of efti, a regimen demonstrated to be both safe and effective in smaller, earlier studies.

Immutep CEO, Marc Voigt, emphasized the drug’s potential: "We are excited about the potential of the TACTI 004 study to deliver a new standard-of-care therapy for patients with metastatic or advanced non-small cell lung cancer. If successful, the study will result in a clinically meaningful and statistically improved survival benefit and thus could potentially be practice changing.”

Lung Cancer Prevalence

Lung cancer remains the leading cause of cancer-related death worldwide, with NSCLC making up 80-85% of cases. Despite advances in immunotherapy, the five-year survival rate for patients diagnosed at an advanced stage remains below 30%. If Immutep’s combination therapy proves successful, it could offer a new option for patients who currently face limited treatment alternatives.

Recruitment for the trial is well underway, with regulatory approvals already secured in key markets including Australia, Canada, Germany, and the United Kingdom. Additional approvals are expected in the coming months, further expanding the study’s reach.

Immutep is developing multiple LAG-3 immunotherapies, including eftilagimod alpha (IMP321) for cancer, IMP761 for autoimmune diseases, and IMP731 (GSK'781), which is returning from GSK. They also have LAG525 (licensed to Novartis) for cancer, a small molecule anti-LAG-3 program with Cardiff University, and other research into novel immunotherapies.

IMM on ASX currently has a market cap of about A$415M, a 52-week high of 46c and a 52-week low of 23c.