Immutep Releases CTOS 2026 Abstract with First Survival Data from EFTISARC-NEO Trial in Soft Tissue Sarcoma

Aakashdeep

11 November 2026 12:32 PM AEDT

Immutep Releases CTOS 2026 Abstract with First Survival Data from EFTISARC-NEO Trial in Soft Tissue Sarcoma

Image Source: Krish Capital Pty Ltd

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Immutep Limited (ASX:IMM) has announced the release of an abstract reporting first survival data from EFTISARC-NEO, an investigator-initiated Phase II trial evaluating eftilagimod alfa (efti) in combination with KEYTRUDA® (pembrolizumab) and radiotherapy as neoadjuvant treatment for patients with resectable soft tissue sarcoma (STS), with the abstract published ahead of a poster discussion session at the Connective Tissue Oncology Society (CTOS) 2026 Annual Meeting.

Key Points

With a median follow-up of 19.1 months, 12-month disease-free survival (DFS), local recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) rates were 81.1%, 94.1% and 86.2%, respectively, in 38 evaluable patients (data cut-off 30 April 2026).
No differences in DFS were observed across tumour grade, stage or histological subtype.
Investigators concluded that efti plus pembrolizumab and radiotherapy as neoadjuvant therapy showed promising preliminary long-term outcomes warranting registrationally relevant trials in patients with STS.
Further analyses will be presented in a poster discussion session on 19 November 2026 at the CTOS 2026 Annual Meeting in Seoul, South Korea, being held from 18–21 November 2026.

EFTISARC-NEO Survival Endpoint Results

The abstract reports interim disease-free survival data and clinicopathological correlates from EFTISARC-NEO. With a data cut-off of 30 April 2026 and a median follow-up of 19.1 months, the 12-month DFS, LRFS and DMFS rates were 81.1%, 94.1% and 86.2%, respectively, across 38 evaluable patients. The survival outcomes reported are secondary endpoints of the trial. The investigators also reported that high infiltration by tumour-infiltrating lymphocytes and tumour hyalinisation/fibrosis after therapy may be associated with better DFS, though they noted that longer follow-up is necessary. Follow-up for DFS and overall survival is ongoing.

Trial Background and Previously Disclosed Outcomes

EFTISARC-NEO is an open-label Phase II trial led by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, primarily funded by a grant from the Polish Medical Research Agency, with Immutep supplying efti. Forty patients were enrolled, with enrolment completed in January 2025. The trial previously met its primary endpoint, with a median tumour hyalinisation/fibrosis of 51.5% in 38 evaluable patients, above the pre-specified target of 35%. Health-related quality of life data presented at the ESMO Congress 2026 showed no significant deterioration during treatment and a statistically significant improvement following surgery.

Efti Regulatory Designations and CTOS Presentation Date

The U.S. Food and Drug Administration granted Orphan Drug Designation to efti for the treatment of STS in April 2026. Efti has also received Fast Track designation from the FDA in first-line head and neck squamous cell carcinoma and first-line non-small cell lung cancer. Immutep stated that further and new analyses from EFTISARC-NEO will be presented in a poster discussion session on 19 November 2026 at the CTOS 2026 Annual Meeting in Seoul, South Korea, and will be the subject of a further company disclosure. The poster with updated data will be made available on the Posters & Publications page of Immutep's website following its presentation.

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