Clinical TrialNov 10, 2026, 06:04 PM
Immutep Ltd: EFTISARC-NEO Trial Shows 81.1% DFS at 12 Months in STS Patients
AI Summary
Immutep Ltd announced encouraging preliminary long-term survival data from the EFTISARC-NEO Phase II trial of eftilagimod alfa (efti) in combination with KEYTRUDA® and radiotherapy for resectable soft tissue sarcoma (STS). The trial demonstrated a 12-month disease-free survival rate of 81.1%, local recurrence-free survival of 94.1%, and distant metastasis-free survival of 86.2% in 38 evaluable patients. The combination therapy also met its primary endpoint of tumor hyalinization/fibrosis. Further analyses will be presented at the CTOS 2026 Annual Meeting.
Key Highlights
- 12-month disease-free survival (DFS) rate of 81.1% in 38 evaluable patients with resectable soft tissue sarcoma (STS).
- 12-month local recurrence-free survival (LRFS) rate of 94.1% in 38 evaluable patients.
- 12-month distant metastasis-free survival (DMFS) rate of 86.2% in 38 evaluable patients.
- Median tumor hyalinization/fibrosis of 51.5% in 38 evaluable patients, exceeding the target of 35%.
- Efti plus KEYTRUDA® and radiotherapy showed promising preliminary long-term outcomes in neoadjuvant therapy for STS.
- Health-related quality of life data showed no significant deterioration during treatment and improvement post-surgery.
- Efti received Orphan Drug Designation for STS treatment from the U.S. FDA in April 2026.
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