Immutep Receives Positive FDA Feedback for Eftilagimod Alfa in 1L HNSCC

Immutep Limited (ASX: IMM), has received encouraging feedback from the US FDA regarding the clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa (efti), for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) in patients with PD-L1 expression below 1 (CPS <1). The feedback follows promising Phase IIb TACTI-003 (KEYNOTE-C34) results, where efti combined with KEYTRUDA® (pembrolizumab) demonstrated potential to address this high unmet need.

The FDA supported advancing development under Project FrontRunner, outlining two possible paths: a randomized registrational trial versus standard-of-care therapy or a smaller single-arm study of 70–90 patients, focused on safety, response rate, and duration of response, followed by a confirmatory trial. Immutep CEO Marc Voigt emphasized that while the company’s primary focus remains the pivotal TACTI-004 Phase III trial in non-small cell lung cancer, the FDA guidance positions efti as a promising therapy for underserved 1L HNSCC patients with CPS <1.

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