• Immutep's pivotal TACTI-004 trial in first-line non-small cell lung cancer (1L NSCLC) received first regulatory approval
• Mature data from INSIGHT-003 in 1L NSCLC demonstrates an excellent 32.9-month median overall survival (OS) and 81.0% 24-month OS rate
• Promising new results in first line head & neck cancer with PD-L1 CPS <1 reported at ESMO IO 2024

Immutep Limited, a clinical-stage biotechnology company developing novel LAG-3 immunotherapies, provides an update on its activities for the quarter ended 31 December 2024 (Q2 FY25). Key highlights include the initiation of the pivotal TACTI-004 Phase III clinical trial of eftilagimod alfa ('efti') for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), receiving regulatory approval from the Australian Therapeutic Goods Administration. Immutep has also reported further positive results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial evaluating efti in combination with pembrolizumab as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with PD-L1 negative tumours. Additionally, the company reported mature data from the INSIGHT-003 trial evaluating efti in combination with pembrolizumab and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous 1L NSCLC, demonstrating a median OS of 32.9 months and a 24-month OS rate of 81.0%. In the EFTISARC-NEO Phase II trial of efti in combination with radiotherapy plus pembrolizumab for soft tissue sarcoma, the combination therapy achieved a greater than three-fold increase in tumour hyalinization/fibrosis compared to historical data from radiotherapy alone. Immutep also reported favourable initial safety data from the Phase I study of IMP761, a first-in-class agonist LAG-3 antibody for autoimmune disease. The company is well-funded with a strong cash, cash equivalent and term deposit balance of approximately A$159.26 million as of 31 December 2024, providing an expected cash reach to the end of CY2026.

Immutep is well-funded with a strong cash, cash equivalent and term deposit balance of approximately A$159.26 million as of 31 December 2024, providing an expected cash reach to the end of CY2026.