ESMO 2025 | EFTISARC-NEO: neoadjuvant eftilagimod alpha, pembrolizumab and RT in STS
Katarzyna Kozak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, discusses the Phase II EFTISARC-NEO study (NCT06128863) of neoadjuvant eftilagimod alpha with pembrolizumab and radiotherapy (RT) in patients with stage III resectable soft tissue sarcoma (STS). The regimen demonstrated a significant increase in tumor hyalinization and fibrosis, meeting the study’s primary endpoint. Treatment was generally manageable, with most adverse events being low grade. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
EFTISARC-NEO is a phase two study of neoadjuvant, eftilagimod alpha, pembrolizumab and radiation therapy in patients with resectable soft tissue sarcoma. Forty patients enrolled in the study received three cycles of pembrolizumab and five doses of FT concurrently with radiation therapy. Within five to six weeks after the completion of radiation therapy, the patients underwent surgery...
EFTISARC-NEO is a phase two study of neoadjuvant, eftilagimod alpha, pembrolizumab and radiation therapy in patients with resectable soft tissue sarcoma. Forty patients enrolled in the study received three cycles of pembrolizumab and five doses of FT concurrently with radiation therapy. Within five to six weeks after the completion of radiation therapy, the patients underwent surgery. The primary endpoint of the study was a pathologic response at the time of surgical resection as assessed by the percentage of tumor hyalinization and fibrosis. The study met its primary endpoint showing a median fibrosis of 51.5%. The best pathological responses were observed in patients with myxofibrous sarcoma and dedifferentiated lipomorphic sarcoma. The neoadjuvant treatment was safe and feasible. All patients underwent surgery without delay. These encouraging results of the EFTISARC-NEO trial warrant further investigation in randomized trials.
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