Immutep (ASX:IMM) says it has received positive and constructive feedback from the US FDA regarding the future clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa (efti), for the first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.
The company stated that the FDA concurred on the potential of efti in combination with MSD's KEYTRUDA (pembrolizumab) to address the significant unmet need in the patient segment, specifically those with PD-L1 expression below one.
“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. The FDA feedback positions Immutep to evaluate options for future collaborative clinical development paths to bring a new, effective and safe treatment option to this underserved patient population,” said Marc Voigt, CEO of Immutep.
“Our primary focus clearly remains the pivotal TACTI-004 Phase III evaluating efti as first line therapy for non-small cell lung cancer and we are excited with its progress to date and the consistent, encouraging feedback we hear from physicians. This focus 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,” added Mr Voigt.