Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced the completion of patient enrollment in the EFTISARC-NEO Phase II trial. This investigator-initiated trial is evaluating the efficacy and safety of eftilagimod alpha (efti) in combination with radiotherapy and KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS).
The Phase II trial, conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, Poland, a national reference center for STS, has reached its enrollment target of 40 patients. The study aims to improve outcomes for patients with STS, a rare cancer that comprises less than 1% of all adult malignancies.
Promising Early Data
Previously presented data from EFTISARC-NEO at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024 showed encouraging results. Among 21 patients available for primary endpoint assessment, the triple combination therapy led to a greater than three-fold increase in tumor hyalinization/fibrosis (median 50%) at the time of surgical resection, compared to a historical median of 15% with radiotherapy alone. Tumor hyalinization/fibrosis is considered an early surrogate endpoint, with associations to improved survival rates in STS patients.
Safety Profile
The combination therapy has demonstrated a favorable safety profile. No grade ≥3 toxicities related to eftilagimod alpha and pembrolizumab were reported during the study, suggesting the treatment is well-tolerated by patients.
Future Expectations
Immutep anticipates further data updates from the EFTISARC-NEO trial in 2025. These updates are expected to provide additional insights into the long-term efficacy and safety of the eftilagimod alpha, radiotherapy, and pembrolizumab combination in treating resectable soft tissue sarcoma. The trial's progress could potentially lead to new treatment strategies for this challenging cancer.
