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News|Articles|November 12, 2026
EFTISARC-NEO Reports 12-Month Survival Data in Soft Tissue Sarcoma
Author(s)Matt Flowers
Fact checked by: Sabrina Serani
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Key Takeaways
- Interim 12-month outcomes in 38 evaluable patients were DFS 81.1%, LRFS 94.1%, and DMFS 86.2% at a 19.1-month median follow-up.
- Trial design pairs soluble LAG-3/MHC II agonism (eftilagimod alfa) with PD-1 blockade and radiotherapy in the neoadjuvant setting before definitive resection.
Eftilagimod alfa plus pembrolizumab and radiotherapy yielded 81.1% disease-free survival at 12 months in patients with resectable soft tissue sarcoma.
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Interim data from the phase 2 EFTISARC-NEO trial (NCT06128863) showed a 12-month disease-free survival (DFS) rate of 81.1% among 38 evaluable patients with resectable soft tissue sarcoma (STS) treated with neoadjuvant eftilagimod alfa (efti), pembrolizumab (Keytruda), and radiotherapy.1
EFTISARC-NEO is an investigator-initiated, open-label phase 2 trial evaluating efti, a soluble LAG-3 protein and major histocompatibility complex class II agonist, in combination with pembrolizumab and radiotherapy before surgery in patients with resectable STS. The trial is led by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland.
The trial enrolled 40 patients, with enrollment completed in January 2025. Its primary end point is pathological response, measured by the percentage of tumor hyalinization and fibrosis at resection. Secondary end points include DFS, local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), overall survival (OS), safety, radiological response, and health-related quality of life. The survival outcomes in the latest analysis are secondary end points.
Disease-Free and Recurrence-Free Survival Outcomes
At a data cutoff of April 30, 2026, the 12-month LRFS rate was 94.1%, and the 12-month DMFS rate was 86.2%, in the same 38 evaluable patients, with a median follow-up of 19.1 months.
No differences in DFS were observed across tumor grade, disease stage, or histological subtype. Investigators also reported that greater tumor-infiltrating lymphocyte infiltration and tumor hyalinization or fibrosis following treatment may be associated with better DFS. However, the company noted that longer follow-up is needed to assess these potential associations.
Trial Previously Met Its Primary End Point
The survival findings follow the trial's previously reported achievement of its primary end point. In October 2025, Immutep, the sponsor, reported a median tumor hyalinization and fibrosis rate of 51.5% among 38 evaluable patients, exceeding the prespecified target of 35%.2 The company also compared this result with an approximately 15% historical rate observed with radiotherapy alone.
Health-related quality-of-life data presented at the
The US FDA granted efti orphan drug designation for STS in April 2026.2
Updated Analyses Expected at CTOS 2026
Additional analyses from EFTISARC-NEO are scheduled for presentation during a poster discussion session on November 19, 2026, at the Connective Tissue Oncology Society (CTOS) 2026 Annual Meeting in Seoul, South Korea, from November 18 to 21. Immutep said it plans to issue a further announcement following the presentation, with the updated poster to be made available through its website.1
The investigators concluded that the preliminary long-term outcomes support further evaluation of neoadjuvant efti plus pembrolizumab and radiotherapy in patients with STS. The ongoing follow-up will provide additional information on DFS and OS.
REFERENCES
1. Immutep announces release of CTOS 2026 abstract reporting first survival data from EFTISARC-NEO. News release. Immutep Limited. November 11, 2026. Accessed November 11, 2026. https://tinyurl.com/5n824763
2. Immutep receives FDA orphan drug designation for eftilagimod alfa in soft tissue sarcoma. News release. Immutep Limited. April 15, 2026. Accessed Novemember 11, 2026. https://tinyurl.com/9b23hn32
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