Immutep Limited (ASX: $IMM) announces positive preliminary topline results from TACTI-003 phase llb trial

Immutep Limited (ASX: $IMM) has released positive preliminary topline results from Cohort B of the TACTI-003 (KEYNOTE- PNC-34) Phase llb trial. The trial evaluates eftilagimod alpha (efti) in combination with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as the first-line treatment for recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression.

Executive Commentary on Preliminary Results

Dr. Martin Forster of the UCL Cancer Institute and University College London Hospital NHS Foundation, London, UK, and TACTI-003 Investigator, stated, 'These preliminary topline results in the first line setting for patients with head and neck squamous cell cancers that do not express PD-L1 are encouraging. Head and neck squamous cell carcinomas are a heterogenous disease that represent a high unmet medical need regardless of PD-L1 expression. This is especially the case for patients with tumours that do not express PD-L1 and those that cannot receive chemotherapy. The ability of efti to work with MSD's anti-PD-1 therapy KEYTRUDA® to potentially improve patients' clinical responses and expand patient populations that respond to the latter, without using chemotherapy, is promising.'

Summary of Preliminary Results and Outlook

The preliminary topline results from Cohort B of the TACTI-003 trial demonstrate a 26.9% response rate and a disease control rate (DCR) of 57.7% in first line head and neck squamous cell carcinoma patients who do not express PD-L1. This indicates a promising potential for efti in combination with KEYTRUDA® to improve clinical responses and expand patient populations that respond to the treatment, particularly for those unable to receive chemotherapy. The Company expects to release additional data, including the complete response rate, from TACTI-003 (Cohorts A & B) in H1 CY2024. Immutep's novel activation of antigen-presenting cells with efti is leading to a significant expansion of memory cytotoxic T cells that anti-PD-(L)1 therapies can act upon, generating a broad anti-cancer immune response. The ongoing data collection, cleaning, and analysis for TACTI-003, along with the FDA Fast Track designation for efti in 1L HNSCC, indicate a positive outlook for Immutep's advancements in cancer immunotherapy.