Immutep Limited's positive efficacy and safety results from TACTI-003 trial

Immutep Limited (ASX: IMM; NASDAQ: IMMP) has revealed positive efficacy and safety results from the TACTI-003 Phase llb trial. The trial evaluated eftilagimod alpha (efti) in combination with MSD's anti-PD-1 therapy KEYTRUDA as the first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma patients (1L HNSCC). The results, presented at the European Society for Medical Oncology (ESMO) Congress 2024, showcased higher response rates and durability in patients with any PD-L1 expression, with a data cut-off of 11 March 2024.

Executive commentary on TACTI-003 trial results

Dr. Claus Kristensen, Head of Section for Thoracic and Head and Neck Oncology, Rigshospitalet, Copenhagen, Denmark, presented the results at the ESMO Congress 2024. He expressed, 'The efficacy and safety data in TACTI-003 are very encouraging and show the significant potential of this novel immunotherapy combination to fight difficult-to-treat head and neck squamous cell carcinomas.' Dr. Frédéric Triebel, CSO of Immutep, highlighted, 'Through multiple clinical trials, we see the promise of efti to not only improve cancer patients' clinical responses to immune checkpoint inhibitors, but also to expand patient populations who respond to them including patients with negative PD-L1 expression.' Marc Voigt, CEO of Immutep, added, 'As we move into the latter half of 2024, we will continue to follow the data in TACTI-003 and start to engage with regulatory authorities regarding potential paths forward.'

Summary of TACTI-003 trial results and future outlook

The TACTI-003 trial demonstrated that efti in combination with KEYTRUDA led to higher Objective Response Rates (ORR) and a high Duration of Response (DOR) in head and neck cancer patients. The statistically significant increase in absolute lymphocyte count biomarker in the efti arm indicates efti's biological activity in a randomised setting. The combination also maintained a favourable safety profile. Immutep aims to discuss the path forward with regulatory agencies, with Overall Survival expected in 2025. The company is hopeful that the positive duration of response seen in previous trials will contribute to an overall survival benefit for patients with first-line head and neck cancer.