Primary Endpoint Met in EFTISARC-NEO Phase II Trial for Soft Tissue Sarcoma

Immutep Limited announced positive results from the EFTISARC-NEO Phase II trial, which evaluated the neoadjuvant use of eftilagimod alfa (efti) in combination with radiotherapy and pembrolizumab for resectable soft tissue sarcoma (STS). The trial met its primary endpoint, achieving a median 51.5% tumour hyalinization/fibrosis, significantly exceeding the prespecified 35% target. This result is over three times greater than the historical outcomes from standard-of-care radiotherapy alone. The data were presented at the 2025 European Society of Medical Oncology (ESMO) Congress. The study demonstrated a good safety profile, with only one grade ≥3 toxicity related to immunotherapy. These findings suggest potential for improved therapeutic options for STS, a condition with high unmet medical need and poor prognosis.