Immutep gets FDA feedback on head and neck cancer drug development

Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced it received feedback from the U.S. Food and Drug Administration regarding clinical development of eftilagimod alfa for treating head and neck cancer patients with low PD-L1 expression levels.

The FDA reviewed data from the TACTI-003 Phase IIb trial, which evaluated eftilagimod alfa in combination with Merck's Keytruda for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients with Combined Positive Score below 1. The agency agreed on the drug combination's potential to address unmet medical needs in this patient segment.

The FDA outlined potential development paths including a randomized registrational trial comparing the combination against standard-of-care therapy, or a smaller single-arm study with 70 to 90 patients focusing on safety, response rate, and duration of response, followed by a confirmatory randomized study.

"We are pleased with the FDA's feedback and guidance that underscores the high unmet need of head and neck cancer patients whose PD-L1 expression level is below one," said Marc Voigt, Immutep's CEO.

Patients with Combined Positive Score below 1 represent up to 20% of first-line head and neck cancer patients. Current treatment options for this population include chemotherapy, as anti-PD-1 therapy alone is only approved for patients with higher PD-L1 expression levels.

Voigt stated the company's primary focus remains the pivotal TACTI-004 Phase III trial evaluating eftilagimod alfa as first-line therapy for non-small cell lung cancer. The company will review options internally and discuss forward paths with stakeholders and potential strategic partners for head and neck cancer development.

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