Immutep, a late-stage biotechnology company focused on developing immunotherapies for cancer and autoimmune diseases, has announced the discontinuation of its Phase III TACTI-004 clinical trial evaluating eftilagimod alfa (efti) in patients with first-line Non-Small Cell Lung Cancer (NSCLC).

The decision follows a planned interim futility analysis conducted by the trial’s Independent Data Monitoring Committee (IDMC), which reviewed available safety and efficacy data and recommended that the study be discontinued as it was unlikely to meet its primary endpoints.

Following the recommendation, Immutep will halt further patient enrolment and initiate an orderly wind-down of the trial. The company stated that patient follow-up and clinical site closures will be conducted in accordance with regulatory and ethical obligations.

Commenting on the development, Marc Voigt, Chief Executive Officer of Immutep, said the outcome of the futility analysis was both disappointing and unexpected given the therapy’s performance in earlier clinical studies. He also acknowledged the contribution of patients, investigators and clinical teams involved in the trial.

TACTI-004 (Two ACTive Immunotherapies) was designed as a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa in combination with Keytruda (pembrolizumab) and chemotherapy as a first-line treatment for patients with advanced or metastatic NSCLC who do not have EGFR, ALK or ROS1 genomic tumour alterations. The study planned to enrol approximately 756 patients across more than 150 clinical sites in over 25 countries.

Participants were randomised in a 1:1 ratio to receive either eftilagimod alfa combined with pembrolizumab and chemotherapy or pembrolizumab plus chemotherapy and placebo. The trial’s dual primary endpoints were progression-free survival and overall survival.

Eftilagimod alfa is a first-in-class MHC Class II agonist immunotherapy designed to activate antigen-presenting cells, such as dendritic cells and monocytes, through the MHC Class II pathway. This activation is intended to stimulate both the innate and adaptive immune systems to generate a broad anti-cancer immune response.

Despite the discontinuation of TACTI-004, Immutep said it remains committed to advancing its broader pipeline of immunotherapy programmes, including ongoing research involving efti across multiple solid tumour indications such as head and neck cancer, breast cancer and soft tissue sarcoma.

The company also noted that the termination of the trial is expected to extend its cash runway beyond the previously projected timeline of the second quarter of calendar year 2027. Immutep plans to provide an updated financial outlook after completing a full operational and clinical analysis of the study data.