Immutep Limited announced that it has enrolled and randomised over 50% of the planned 154 patients in the TACTI-003 Phase IIb trial. TACTI-003 is evaluating Immutep's first-in-class soluble LAG-3 protein eftilagimod alpha, in combination with MSD's anti-PD-1 therapy KEYTRUDA as 1st line treatment of recurrent or metastatic head and neck squamous cell carcinoma. The 1:1 randomised, controlled multinational TACTI-003 trial is currently accruing patients at over 25 centers in the United States, Australia, and Europe, and is expected to be fully recruited by mid-2023.

Based largely on the promising data in 2nd line HNSCC from the Phase II TACTI-002 trial, including encouraging overall response rates regardless of PD-L1 expression and five complete responses eftilagimod alpha was granted Fast Track designation by the FDA in April 2021 for treatment of 1L HNSCC. As recently announced, the Independent Data Monitoring Committee for the TACTI-003 trial reviewed initial safety data and recommended continuing the trial with no modifications. The IDMC also reviewed initial efficacy data, although this was not the primary focus of the analysis.

HNSCC is the sixth most common cancer by incidence worldwide, with 890,000 new cases and 450,000 deaths reported in 2018. HNSCC is an aggressive, genetically complex, and difficult to treat cancer. Furthermore, HNSCC is associated with high levels of psychological distress and compromised quality of life.

As such, HNSCC patients are in need of improved treatment options.