- First survival data from EFTISARC-NEO, released in CTOS 2026 Abstract, demonstrate encouraging preliminary long-term outcomes in patients with resectable soft tissue sarcoma (STS).
- 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.
- Investigators conclude that efti plus KEYTRUDA® (pembrolizumab) and radiotherapy as neoadjuvant therapy showed promising preliminary long-term outcomes warranting registrationally relevant trials in patients with STS.
- Further and new analyses will be presented in a poster discussion session on 19 November 2026 and will be the subject of a further announcement by the Company.
SYDNEY, AUSTRALIA, Nov. 11, 2026 (GLOBE NEWSWIRE) — Immutep Limited (ASX: IMM; NASDAQ: IMMP) today announced the release of an abstract reporting interim disease-free survival data and clinicopathological correlates from EFTISARC-NEO, the investigator-initiated Phase II trial of eftilagimod alfa (efti) plus KEYTRUDA® (pembrolizumab) and radiotherapy as neoadjuvant treatment for resectable soft tissue sarcoma (STS). Further detail and analyses will be presented in a poster discussion session on 19 November 2026 at the Connective Tissue Oncology Society (CTOS) 2026 Annual Meeting, being held from 18–21 November 2026 in Seoul, South Korea.
As reported in October 2025, EFTISARC-NEO has met its primary endpoint, with a median tumour hyalinisation/fibrosis of 51.5% in 38 evaluable patients, well above the pre-specified target of 35% and approximately 15% historically observed with radiotherapy alone.1 Health-related quality of life data presented at the ESMO Congress 2026 in October showed no significant deterioration during treatment and a statistically significant improvement following surgery. The U.S. Food and Drug Administration granted Orphan Drug Designation to efti for the treatment of STS in April 2026. The survival outcomes reported here are secondary endpoints of the trial.
With a median follow-up of 19.1 months, the 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.
The investigators concluded that efti plus pembrolizumab on top of standard radiotherapy as neoadjuvant therapy showed promising preliminary long-term outcomes warranting registrationally relevant trials in patients with STS. The investigators reported that high infiltration by tumour-infiltrating lymphocytes (TIL) and tumour hyalinisation/fibrosis after therapy may be associated with better DFS but that longer follow-up is necessary.
Follow-up for DFS and overall survival is ongoing.
For further details see the Events section of Immutep’s website. The poster with updated data will be made available on the Posters & Publications page of Immutep’s website at www.immutep.com following its presentation at the meeting.
About EFTISARC-NEO
EFTISARC-NEO is an investigator-initiated, open-label Phase II trial evaluating eftilagimod alfa in combination with KEYTRUDA® (pembrolizumab) and radiotherapy as neoadjuvant treatment for patients with resectable soft tissue sarcoma. The trial is led by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, and is primarily funded by a grant from the Polish Medical Research Agency, with Immutep supplying efti. The primary endpoint is pathological response, measured as the percentage of tumour hyalinisation/fibrosis at resection. Secondary endpoints include safety, disease-free survival, local recurrence-free survival, distant metastasis-free survival, overall survival, radiological response and health-related quality of life. Forty patients were enrolled, with enrolment completed in January 2025 (ClinicalTrials.gov: NCT06128863).
About Eftilagimod Alfa (efti)
Eftilagimod alfa (efti) is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that activates antigen-presenting cells through the MHC Class II pathway, engaging both innate and adaptive immunity, including the priming of cytotoxic CD8+ T cells and the production of co-stimulatory signals and cytokines. Its favourable safety profile enables combination with anti-PD-(L)1 therapy, radiotherapy and/or chemotherapy. Efti has received Fast Track designation from the U.S. Food and Drug Administration in first-line head and neck squamous cell carcinoma and first-line non-small cell lung cancer, and Orphan Drug Designation in soft tissue sarcoma.
About Immutep
Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding anticipated clinical development, regulatory progress and potential benefits of eftilagimod alfa. These forward-looking statements are based on current expectations, estimates and projections, and involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from those expressed or implied in such statements.
Factors that could cause actual results to differ materially include risks associated with clinical trial outcomes, regulatory developments, and the Company’s ability to advance its product candidates.
Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this release. Immutep undertakes no obligation to update or revise such statements, except as required by applicable law.
Disclaimer
This announcement has been prepared for informational purposes only and does not constitute an offer to sell, or a solicitation of an offer to buy, securities in any jurisdiction.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
1 Schaefer IM, Hornick JL, Barysauskas CM, Raut CP, Patel SA, Royce TJ, Fletcher CDM, Baldini EH. Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):375-383.
Australian Investors/Media:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; eleanor.pearson@sodali.com
US Investors/Media:
Matthew Beck, astr partners
+1 (917) 415-1750; matthew.beck@astrpartners.com
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