Immutep (NASDAQ:IMMP) announced on March 13, 2026, that it will shut down its Phase III TACTI-004 clinical trial evaluating eftilagimod alpha ("efti") in combination with anti-PD-1 therapy for first-line non-small cell lung cancer (NSCLC).
The decision follows a planned interim futility analysis conducted by an Independent Data Monitoring Committee (IDMC), which determined the study was unlikely to meet its primary endpoints.
The Sydney-based biotechnology company confirmed that enrollment for the trial will be halted immediately.
Immutep has initiated the process of winding down the study, which involves ongoing patient follow-up and the formal closing of clinical sites.
Management stated they are currently reviewing the comprehensive data set to determine the exact factors behind the futility finding and to assess the next steps for the efti development program in other oncology indications.
The discontinuation of this large-scale Phase III trial has immediate implications for the company’s financial outlook.
Immutep noted that the reduction in planned clinical expenditures will extend its cash runway "well beyond" its previous guidance of the second quarter of 2027.
The company intends to provide a specific updated financial outlook once it completes an operational assessment of the costs associated with the trial’s termination.
Despite the setback in first-line NSCLC, Immutep continues to evaluate efti, a soluble LAG-3 protein, in other settings, including head and neck squamous cell carcinoma and other combination therapies.