Immutep achieves 50% enrollment milestone in Phase IIB TACTI-003 trial

Immutep (IMMP) announces that it has enrolled and randomized 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 Merck & Co’s (MRK) anti-PD-1 therapy KEYTRUDA as 1st line treatment of recurrent or metastatic head and neck squamous cell carcinoma. Marc Voigt, CEO of Immutep stated: "We are pleased to reach this important milestone and extend our sincere appreciation to our investigators, clinical team, partners, and most importantly patients, that have participated in this study. As clinical evidence showing the compelling benefits of combining efti with immune checkpoint therapies such as pembrolizumab continues to grow, we are increasingly excited about efti’s potential to safely deliver superior clinical outcomes and meaningfully expand the population of cancer patients that respond to treatment." 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.