Immutep Announces Clinical Collaboration with MSD to Evaluate Efti in Combination with KEYTRUDA® (pembrolizumab) in Pivotal Phase III Trial

Core Viewpoint - Immutep Limited has entered a collaboration with MSD to conduct a Phase III trial (TACTI-004) evaluating the efficacy of efti in combination with KEYTRUDA and standard chemotherapy for first-line treatment of non-small cell lung cancer (NSCLC) [1][4][5] Group 1: Trial Details - TACTI-004 will enroll approximately 750 patients, regardless of PD-L1 expression, to address the entire NSCLC market eligible for anti-PD-1 therapy [1][3] - The trial is designed as a 1:1 randomized, double-blind, multinational, controlled study with dual primary endpoints of progression-free survival and overall survival [3][4] - The collaboration allows both companies to seek marketing authorization for the combination treatment while retaining commercial rights to their respective compounds [5] Group 2: Efficacy and Safety - Efti, in combination with KEYTRUDA and chemotherapy, has shown compelling efficacy and favorable safety across all levels of PD-L1 expression in prior trials [1][2][6] - Over 75% of patients in previous trials had a PD-L1 Tumor Proportion Score (TPS) of less than 50%, demonstrating strong efficacy in typically less responsive patients [7] - The combination therapy has been well tolerated, indicating a promising safety profile [7] Group 3: Background and Significance - Lung cancer is the second most common cancer, with NSCLC accounting for approximately 80-85% of all lung cancers, impacting an estimated 1.87 million people annually [9] - The collaboration aims to set a new standard of care by improving clinical outcomes and broadening the patient response across the NSCLC population [2][4] - Efti is a first-in-class antigen presenting cell activator that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [10][11]