Immutep announces update for TACTI-004 Phase III trial

Immutep (IMMP) announces a patient enrolment update for the TACTI-004 Phase III trial evaluating eftilagimod alfa in combination with MSD’s (MRK) anti-PD-1 therapy KEYTRUDA and chemotherapy as first line treatment for advanced or metastatic non-small cell lung cancer. This registrational Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount necessary to conduct the futility analysis. Additionally, the number of activated clinical trial sites continues to expand at a strong pace and there are now over 100 active clinical sites across 24 countries globally. The futility analysis will be assessed by an independent data monitoring committee, IDMC, based on the data of a predefined number of patients with sufficient follow-up and predefined criteria for efficacy. The trial remains on track for the IDMC to conduct the futility analysis in the first quarter of CY2026. Immutep Chief Executive Officer, Marc Voigt, said, “We are very pleased with the pace of enrolment in our pivotal Phase III trial that we believe has the potential to change the treatment landscape in non-small cell lung cancer, one of the largest indications in oncology with over two million diagnoses annually worldwide. The trial remains on track for key milestones ahead including futility analysis in early 2026.”