• First patient dosed in Immutep's pivotal TACTI-004 Phase III trial
• Trial to evaluate eftilagimod alfa in combination with pembrolizumab and chemotherapy as first-line treatment for advanced/metastatic non-small cell lung cancer
• Trial to enroll approximately 756 patients at over 150 clinical sites globally

Immutep Limited has announced that the first patient has been successfully dosed in the company's pivotal TACTI-004 Phase III trial. TACTI-004 will evaluate Immutep's eftilagimod alfa, a first-in-class MHC Class II agonist, in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and chemotherapy as first-line treatment for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global Phase III trial will enroll approximately 756 patients at more than 150 clinical sites across over 25 countries. Patients will be randomized 1:1 to receive either efti in combination with pembrolizumab and chemotherapy or pembrolizumab in combination with chemotherapy and placebo. The study's dual primary endpoints are progression-free survival and overall survival. 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.

Immutep has not provided any high-importance, price-sensitive forward-looking financial metrics in the announcement.

Immutep is excited about the potential of the TACTI-004 study to deliver a new standard-of-care therapy for patients with metastatic or advanced non-small cell lung cancer that includes efti in combination with KEYTRUDA. If successful, the study will result in a clinically meaningful and statistically improved survival benefit and thus could potentially be practice changing.