• Positive and constructive feedback from FDA on future clinical development of eftilagimod alfa (efti) for 1L HNSCC patients with CPS <1
• FDA agreed on the potential of efti+KEYTRUDA to address unmet need in CPS <1 patient segment
• Paths for future clinical development and potential accelerated approval include randomized registrational trial or smaller single-arm study

Immutep Limited has received positive and constructive feedback from the US Food and Drug Administration (FDA) regarding future 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) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1). Based on the encouraging data in 1L HNSCC with CPS <1 from the TACTI-003 (KEYNOTE-C34) Phase IIb trial evaluating efti in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA, the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS <1 patient segment and is supportive of the combination's further development. Paths for future clinical development and potential accelerated approval in light of the FDA's Project FrontRunner include a randomised registrational trial evaluating efti in combination with KEYTRUDA against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 - 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data.

The company's primary focus remains the pivotal TACTI-004 Phase III evaluating efti as first line therapy for non-small cell lung cancer, and the feedback and additional considerations will be reviewed internally and discussed with stakeholders and potential strategic partners in regards to forward paths in head and neck cancer.