Immutep (ASX: IMM) has received Orphan Drug Designation from the US Food and Drug Administration for eftilagimod alfa (efti) for the treatment of soft tissue sarcoma, a rare cancer with limited treatment options. The designation follows encouraging Phase II data from the EFTISARC-NEO study, where efti in combination with radiotherapy and KEYTRUDA® demonstrated a median tumour response significantly above both the study target and historical benchmarks, alongside a favourable safety profile.
The FDA designation provides regulatory and commercial incentives, including potential market exclusivity, and supports a potential pathway into a late-stage clinical study in the neoadjuvant setting. Chief Executive Officer Marc Voigt said the designation reflects the potential of efti in a difficult-to-treat cancer and, alongside results from the EFTISARC-NEO trial, may provide a pathway into a late-stage study, with outcomes from the company’s ongoing strategic review expected to inform future clinical development decisions. To read the full announcement, click here.
