Immutep Gets Positive Feedback From FDA On Late-Stage Clinical Development Of Eftilagimod Alfa

(RTTNews) - Immutep Limited (IMMP), a late-stage immunotherapy company targeting cancer and autoimmune diseases, Tuesday announced it 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, 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 encouraging data in 1L HNSCC with CPS <1 from the TACTI-003 Phase IIb trial evaluating efti in combination with MSD's anti-PD-1 KEYTRUDA (pembrolizumab), 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.

"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.