Immutep(US:IMMP) Globenewswire·2025-05-05 12:00Core Insights - Immutep Limited has reported a median Overall Survival (OS) of 17.6 months in Cohort B of the TACTI-003 Phase IIb trial for patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) with PD-L1 expression below 1 [1][2] Group 1: Clinical Trial Results - The 17.6-month median OS in evaluable patients (N=31) is significantly better than historical results from standard-of-care treatments, which include 10.7 months from cetuximab + chemotherapy, 11.3 months from anti-PD-1 therapy + chemotherapy, and 7.9 months from anti-PD-1 monotherapy [2] - Efti in combination with pembrolizumab has shown a high overall response rate with multiple complete responses, indicating a promising efficacy profile [4][5] Group 2: Unmet Medical Need - Patients with CPS <1 in 1L HNSCC represent a high unmet medical need, as up to 20% of these patients lack approved immunotherapy-only treatment options [3][6] - The combination of efti and pembrolizumab addresses this gap, as current treatments for this population typically involve chemotherapy [3][6] Group 3: Safety and Regulatory Path - The combination therapy continues to be well-tolerated with no new safety signals reported, reinforcing its potential as a viable treatment option [4] - Immutep has requested a meeting with the U.S. FDA to discuss potential paths to approval for efti in 1L HNSCC with PD-L1 CPS <1, following its Fast Track designation [7][10] Group 4: About Efti - Efti is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [8] - The drug is under evaluation for various solid tumors, including non-small cell lung cancer and metastatic breast cancer, highlighting its broad therapeutic potential [9] Group 5: Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 [11]