TACTI-004 Phase III Study in First Line NSCLC to be discontinued following Futility Analysis

Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended the discontinuation of the TACTI-004 Phase III trial evaluating eftilagimod alfa (efti) in patients with non-small cell lung cancer due to futility analysis results [1][2] Group 1: Trial Discontinuation - The trial will be halted, and the company will implement an orderly wind down, including patient follow-up and site closure in compliance with regulatory and ethical obligations [2] - The CEO expressed disappointment and surprise regarding the futility analysis outcome, highlighting the previous performance of efti in other clinical trials [3] Group 2: Financial Outlook - Following the trial's discontinuation, the company anticipates its cash runway will extend beyond the previously guided timeframe of Q2 CY2027 [3] - An updated outlook on the revised cash runway will be provided after operational assessments and a full analysis of the study data [3] Group 3: About TACTI-004 - TACTI-004 is a randomized, double-blind, controlled Phase III study evaluating efti in combination with KEYTRUDA and chemotherapy for advanced or metastatic non-small cell lung cancer [4] - The trial aimed to enroll approximately 756 patients across over 150 clinical sites in more than 25 countries, with dual primary endpoints of progression-free survival and overall survival [4] Group 4: About Eftilagimod Alfa (Efti) - Efti is a novel immunotherapy that activates antigen-presenting cells via the MHC Class II pathway to combat cancer [5] - It has a favorable safety profile and is under evaluation for various solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma, and breast cancer [6] Group 5: About Immutep - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases [7] - The company is a pioneer in therapeutics related to Lymphocyte Activation Gene-3 (LAG-3) and aims to leverage its expertise to provide innovative treatment options and maximize shareholder value [7]