Immutep Reports Operational Progress In TACTI-004 Phase III Trial Evaluating Eftilagimod Alfa In Combination With MSD's Anti-PD-1 Therapy, KEYTRUDA, And Chemotherapy As First Line Therapy For Advanced/Metastatic Non-Small Cell Lung Cancer

• The registrational TACTI-004 Phase III has enrolled 289 patients globally, over 38% of the trial's targeted enrolment
• Strong operational progress continues globally with over 120 activated clinical sites and 27 countries having received full regulatory approvals including the United States
• Futility analysis remains on track for the first quarter of CY2026 and completion of patient enrolment in the third quarter of CY2026

SYDNEY, AUSTRALIA, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today reports strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer.

The registrational TACTI-004 trial has enrolled 289 patients (over 38% of the trial's targeted enrolment of 756 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.

This includes the United States where the first of multiple clinical sites has received full regulatory clearance following the recent completion of the FDA's Project Optimus initiative and subsequent receipt of local and central Institutional Review Board (IRB) 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.