New data presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting reveals promising results from a Phase II trial of Immutep's eftilagimod alpha (efti) in combination with radiotherapy and KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS). The EFTISARC-NEO trial demonstrated significant efficacy in the neoadjuvant setting for resectable STS, offering a potential new treatment avenue for this challenging disease.
Significant Increase in Tumor Hyalinization
The preliminary analysis, involving 21 patients available for primary endpoint assessment, showcased a notable increase in tumor hyalinization. The triple combination therapy led to a threefold increase in tumor hyalinization, the primary endpoint of the study and an important predictor of overall survival, as compared to historical results from radiotherapy alone. This outcome underscores the potential of the combination therapy to enhance treatment efficacy in STS patients.
Investigator Perspectives
Katarzyna Kozak, M.D., Ph.D., and Pawel Sobczuk, M.D., Ph.D., principal investigators of the EFTISARC-NEO trial from the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO (Warsaw), expressed optimism about the findings. "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," they stated. "These very encouraging results we are presenting today build our confidence in the synergistic effects of this new therapeutic approach and its potential to treat these patients in dire need of more effective therapies. In particular, the high level of hyalinization/fibrosis achieved with this novel combination therapy, three-times above historical results from standard radiotherapy, demonstrates remarkable efficacy in patients with resectable soft tissue sarcomas."
The results suggest that the combination of efti, pembrolizumab, and radiotherapy could offer a significant improvement in outcomes for patients with resectable soft tissue sarcomas, addressing a critical unmet need in this patient population.