Immutep's Efti Shows Excellent Survival Data from INSIGHT-003 Trial in Non-Small Cell Lung Cancer

Core Insights - Immutep Limited announced positive results from the INSIGHT-003 Phase I trial, showing significant improvements in overall survival and progression-free survival for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with eftilagimod alpha (efti) in combination with KEYTRUDA® and chemotherapy [1][4]. Survival Data - Median Overall Survival (OS) is reported at 32.9 months, with a Median Progression-Free Survival (PFS) of 12.7 months, and a 24-month OS rate of 81.0% [3][4]. - These results significantly outperform historical controls, which reported a median OS of 22.0 months and a median PFS of 9.0 months for similar patient populations [3][4]. Response Rates - The Overall Response Rate (ORR) for all evaluable patients (N=40) shows a significant improvement compared to historical controls, with specific rates as follows: - 75.0% ORR in patients with high PD-L1 expression (TPS >50%) compared to 62.1% in historical controls - 58.8% ORR in patients with low PD-L1 expression (TPS 1-49%) compared to 49.2% - 47.4% ORR in patients with negative PD-L1 expression (TPS <1%) compared to 32.3% [5][6]. Safety Profile - The safety profile of efti in combination with pembrolizumab and chemotherapy remains favorable, with no new safety signals reported [7]. Future Developments - The INSIGHT-003 trial is nearing completion of patient enrollment, with additional data updates expected in 2025 and beyond [8][9]. - The upcoming TACTI-004 Phase III trial will further evaluate the efficacy of this combination therapy, focusing on PFS and OS as dual primary endpoints [2][4]. Company Overview - Immutep is a clinical-stage biotechnology company focused on developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, aiming to provide innovative treatment options and maximize shareholder value [10].