• Global Phase III trial has enrolled and randomised over 170 patients
• Over 100 clinical sites across 24 countries now activated and open for recruitment
• Futility analysis remains on track for completion in the first quarter of CY2026

Immutep Limited, a late-stage immunotherapy company, today announces a patient enrolment update for 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 treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC). The 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 (minimum 12 weeks) and predefined criteria for efficacy. The trial remains on track for the IDMC to conduct the futility analysis in the first quarter of CY2026. Lung cancer is the leading cause of death among all cancer types, and NSCLC is the most common type, representing ~80-85% of all diagnoses. The condition is often diagnosed at a late stage, and less than 30% of patients are alive five years after diagnosis, highlighting the high unmet need for additional treatment options.

The TACTI-004 trial follows positive efficacy and safety results from two previous studies, TACTI-002 and INSIGHT-003, which tested efti with KEYTRUDA in 1L NSCLC. With in total over 165 patients enrolled, both trials demonstrate that efti enhances anti-PD-1 therapy regardless of PD-L1 expression levels, leading to high response rates and strong progression-free survival.