Immutep Halts TACTI-004 for Futility

Immutep Limited announced that the Independent Data Monitoring Committee (IDMC) has recommended discontinuing the Phase III TACTI-004 trial evaluating eftilagimod alfa (efti) as part of a first-line treatment regimen for patients with advanced or metastatic non-small cell lung cancer (NSCLC). The recommendation followed a planned interim futility analysis conducted according to the study protocol.

After reviewing available safety and efficacy data, the IDMC concluded that the trial was unlikely to meet its primary endpoints and advised that the study be discontinued for futility. In response, Immutep will halt patient enrollment and initiate an orderly wind-down of the trial, including continued follow-up of enrolled participants and closure of clinical sites in line with regulatory and ethical requirements.

“We are very disappointed and surprised with the outcome of the futility analysis, in light of efti’s performance in every other clinical trial,” said Marc Voigt, Chief Executive Officer of Immutep. He thanked the patients, investigators, and clinical teams who participated in the study and noted that the company has begun a comprehensive review of the trial data to better understand the findings and determine next steps for the program.

TACTI-004 (NCT06726265) was a randomized, double-blind, controlled Phase III trial designed to evaluate eftilagimod alfa in combination with pembrolizumab (KEYTRUDA) and chemotherapy as first-line therapy for patients with advanced or metastatic NSCLC without EGFR, ALK, or ROS1 genomic tumor alterations. The global study planned to enroll approximately 756 patients at more than 150 clinical sites across over 25 countries, regardless of PD-L1 expression and including both squamous and non-squamous disease. Participants were randomized 1:1 to receive either efti with pembrolizumab and chemotherapy or pembrolizumab with chemotherapy and placebo. The trial’s dual primary endpoints were progression-free survival and overall survival.

Eftilagimod alfa is an investigational immunotherapy designed to activate antigen-presenting cells through the MHC Class II pathway. By stimulating dendritic cells and monocytes, the therapy aims to enhance both innate and adaptive immune responses, including the activation of cytotoxic T cells and the production of immune-stimulating cytokines.

Despite the discontinuation of TACTI-004, Immutep stated it remains focused on advancing its broader pipeline of therapies involving efti. The company noted that ending the study earlier than planned is expected to extend its cash runway beyond the previously projected timeline of the second quarter of 2027. A revised financial outlook and capital allocation strategy will be provided after the full analysis of trial data and operational assessments are completed.

Efti continues to be evaluated in several other clinical programs across multiple solid tumors, including head and neck squamous cell carcinoma, soft tissue sarcoma, and breast cancer. The therapy has received Fast Track designation from the U.S. Food and Drug Administration for use in first-line head and neck cancer and first-line NSCLC.

Reference

TACTI-004 Phase III Study in First Line NSCLC to be discontinued following Futility Analysis, 13 March 2026, https://www.immutep.com/11560-2/

Study of Eftilagimod Alfa (Efti) in Combination with Pembrolizumab and Chemotherapy Versus Placebo in Combination with Pembrolizumab and Chemotherapy in Participants with Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004), ClinicalTrials.gov ID NCT06726265, https://clinicaltrials.gov/study/NCT06726265