Immutep Announces Successful Meeting with FDA on Phase III Design in Non-Small Cell Lung Cancer

Core Insights - The FDA has provided positive feedback on the TACTI-004 Phase III trial design for evaluating efti in combination with KEYTRUDA and standard chemotherapy for first-line non-small cell lung cancer (NSCLC) [1][2][4] - The trial aims to enroll approximately 750 patients, regardless of PD-L1 expression, to address the entire first-line NSCLC market eligible for anti-PD-1 therapy [1][3][6] Regulatory Developments - The feedback from the FDA, along with previous input from the Paul-Ehrlich-Institut and the Spanish Agency for Medicines and Health Products, concludes the preparatory regulatory interactions for the trial [2] - This marks a significant advancement in developing effective treatments for both non-squamous and squamous 1L NSCLC patients [2] Trial Design - TACTI-004 will be a 1:1 randomized, double-blind, multinational, controlled clinical trial comparing efti with KEYTRUDA and chemotherapy against the standard of care [6] - The dual primary endpoints of the trial will be progression-free survival and overall survival, with a prespecified futility boundary and a pre-planned interim analysis [6] Product Information - Efti is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [7] - Efti is being evaluated for various solid tumors, including NSCLC, and has received Fast Track designation from the FDA for first-line indications in both NSCLC and head and neck squamous cell carcinoma [8] Company Overview - Immutep is a clinical-stage biotechnology company focused on developing novel LAG-3 immunotherapies for cancer and autoimmune diseases [9] - The company aims to leverage its expertise in LAG-3 to provide innovative treatment options and maximize shareholder value [9]