Immutep Achieves 50% Enrolment in Global TACTI-004-1L NSCLC

• TACTI-004 trial in 1L NSCLC has enrolled 378 patients globally, 50% of the trial's target
• Futility analysis and completion of patient enrolment on track for Q1 and Q3 2026 respectively
• Combination of efti with KEYTRUDA and chemotherapy has potential to establish new standard of care in 1L NSCLC

Immutep Limited, a late-stage immunotherapy company, has announced that it has achieved 50% of the patient enrolment target in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first-line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC). The registrational TACTI-004 trial has enrolled 378 patients globally, and enrolment continues at a robust pace, with over 140 clinical sites now activated across 27 countries. The futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively. The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients' survival.

The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients' survival.