Immutep announces progress in global TACTI-004 Phase III, enrollment continues

Immutep (IMMP) reports strong operational progress in 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 therapy for advanced/metastatic non-small cell lung cancer. The registrational TACTI-004 trial has enrolled 289 patients, and enrolment continues at a robust pace. Additionally, the number of activated clinical sites now exceeds 120 and 27 countries have received full regulatory approvals. As announced on 9 October 2025, TACTI-004 had enrolled the necessary 170 patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Furthermore, Immutep expects to complete patient enrolment in the third quarter of CY2026. Immutep Chief Executive Officer, Marc Voigt, said, “We are very pleased with the strong operational progress of TACTI-004 globally and the robust pace of recruitment. Growing interest in this pivotal trial has been enhanced by the recent licensing deal for efti in emerging markets with Dr Reddy’s. The Immutep team is excited about further delivering on key milestones ahead, including the futility analysis and completion of patient enrolment.”