Core Insights - Immutep Limited has received positive feedback from the FDA regarding the clinical development of its MHC Class II agonist, eftilagimod alfa (efti), for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) patients with PD-L1 expression below 1 [1][2][4] Clinical Development - The FDA acknowledged the potential of efti in combination with Merck's KEYTRUDA (pembrolizumab) for patients with CPS <1, indicating support for further development of this combination therapy [2][4] - Future clinical development paths may include a randomized registrational trial comparing efti with KEYTRUDA against standard-of-care therapy or a smaller single-arm study focusing on safety and response rates, followed by a confirmatory randomized study [3][6] Market Need - Patients with CPS <1 in 1L HNSCC represent a significant unmet medical need, with up to 20% of these patients not benefiting from current anti-PD-1 therapies, which are only approved for those with PD-L1 expression (CPS >1) [7] - Current treatment options for patients with PD-L1 CPS <1 are limited to chemotherapy [7] Company Focus - The primary focus of Immutep remains on the pivotal TACTI-004 Phase III trial evaluating efti as first-line therapy for non-small cell lung cancer, with positive feedback from physicians regarding its progress [5] - The company is considering future collaborative clinical development paths for head and neck cancer based on FDA feedback [4][5] About Immutep - Immutep is a late-stage biotechnology company specializing in immunotherapies for cancer and autoimmune diseases, particularly focusing on Lymphocyte Activation Gene-3 (LAG-3) [8] - The company aims to leverage its expertise to provide innovative treatment options and maximize shareholder value [8]

Core Insights - Immutep Limited has successfully dosed the first patient in its pivotal TACTI-004 Phase III trial, evaluating eftilagimod alfa in combination with KEYTRUDA and chemotherapy for advanced non-small cell lung cancer [1][6] Company Overview - Immutep is a late-stage biotechnology company focused on developing immunotherapies for cancer and autoimmune diseases, particularly leveraging LAG-3 to stimulate or suppress immune responses [8] Trial Details - TACTI-004 is a randomized, double-blind, controlled Phase III study enrolling approximately 756 patients across over 150 clinical sites in more than 25 countries, targeting advanced or metastatic non-small cell lung cancer without specific genomic aberrations [5][7] - The trial's dual primary endpoints are progression-free survival and overall survival, with recruitment currently underway [7] Market Context - Lung cancer is the leading cause of cancer-related deaths, with an expected increase to approximately 3 million cases globally by 2030, and non-small cell lung cancer (NSCLC) accounts for about 80-85% of all lung cancer diagnoses [3] - There is a significant unmet need for new treatment options in NSCLC, as less than 30% of patients survive five years post-diagnosis [3]