Immutep receives FDA feedback on clinical development of eftilagimod alfa

Immutep (IMMP) received positive and constructive feedback from the US Food and Drug Administration, regarding future clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa, for first line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients who have PD-L1 expression below 1. Based on its review of the data in 1L HNSCC with CPS less than1 from the TACTI-003 Phase IIb trial evaluating efti in combination with MSD’s, the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS less than1 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 studywith safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data. Project FrontRunner is an FDA Oncology Center of Excellence initiative to encourage drug sponsors to consider when it may be appropriate to develop and seek approval of cancer drugs for advanced/metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. In this setting, advancing new effective therapies has the greatest potential to significantly improve quantity and quality of patients’ lives. Patients with CPS less than1 in 1L HNSCC represent a treatment population with high unmet medical need. Up to 20% of 1L HNSCC patients have CPS less than1 and despite immunotherapy’s progress in fighting cancer, anti-PD-1 therapy alone is only approved for patients who express PD-L1. All currently available treatment options for patients with PD-L1 CPS less than1 include chemotherapy