A Phase II investigator-initiated trial, EFTISARC-NEO, has revealed promising data for patients with soft tissue sarcoma (STS) using a combination therapy involving eftilagimod alpha (efti), pembrolizumab, and radiotherapy. The results, presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting, indicate significant efficacy in the neoadjuvant setting for resectable STS.
The trial's principal investigators, Katarzyna Kozak, M.D., Ph.D., and Pawel Sobczuk, M.D., Ph.D., from the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO (Warsaw), emphasized the potential of efti's mechanism of action to complement radiotherapy and pembrolizumab. They stated that the encouraging results build confidence in the synergistic effects of this therapeutic approach for patients in dire need of more effective therapies.
Significant Increase in Tumor Hyalinization
Preliminary analysis of 21 patients showed a significant increase in tumor hyalinization, the primary endpoint of the study. The level of hyalinization/fibrosis achieved with the novel combination therapy was three times higher than historical results from standard radiotherapy, demonstrating remarkable efficacy in patients with resectable soft tissue sarcomas.
"Our belief in efti’s unique mechanism of action to complement radiotherapy and pembrolizumab in order drive better outcomes for patients with this rare aggressive disease was the foundation of the EFTISARC-NEO trial," the investigators noted.
Implications for Soft Tissue Sarcoma Treatment
Soft tissue sarcomas are a rare and heterogeneous group of cancers that develop in the soft tissues of the body. The current standard of care often involves surgery, radiation, and chemotherapy, but outcomes can be poor, especially in advanced stages. The EFTISARC-NEO trial suggests that the combination of eftilagimod alpha, pembrolizumab, and radiotherapy could offer a more effective treatment option for patients with resectable STS. The observed increase in tumor hyalinization is particularly encouraging, as it is an important predictor of overall survival.
