Quality of life remained stable during neoadjuvant treatment with efti, pembrolizumab and radiotherapy, with statistically significant improvement after surgery
SYDNEY, AUSTRALIA, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage immunotherapy company targeting cancer and autoimmune diseases, today announced health-related quality of life (HRQoL) data from the investigator-initiated EFTISARC-NEO Phase II trial. The data are being presented in an ePoster at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27, 2026 in Madrid, Spain.
EFTISARC-NEO is evaluating eftilagimod alfa (“efti”) in combination with KEYTRUDA® (pembrolizumab) and radiotherapy in the neoadjuvant treatment of patients with resectable soft tissue sarcoma (STS). HRQoL is a secondary endpoint of the trial, and these findings build on the previously reported primary endpoint result in which the combination achieved a median 51.5% tumour hyalinization/fibrosis in the evaluable population (N=38), significantly exceeding the prespecified 35% target (p<0.001).
Patient-reported outcomes were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at baseline, every 6 weeks during treatment and every 12 weeks after treatment. The trial enrolled 40 patients, of whom 38 were evaluable for the primary endpoint. All patients completed the QLQ-C30 at baseline, and between 29 and 38 patients completed it at each subsequent assessment.
Key findings
- General health status remained stable throughout the observation period, with no statistically significant deterioration in any measured scale during treatment.
- The QLQ-C30 summary score showed a statistically significant improvement after surgery of 6.0 points (95% CI: 1.80–10.19; p=0.008).
- Role and social functioning showed statistically significant improvements after surgery of 12.7 points (95% CI: 2.31–23.09; p=0.02) and 8.1 points (95% CI: 1.63–14.56; p=0.02), respectively.
- Patient-reported fatigue was statistically significantly lower than at baseline after surgery, by up to 14.2 points (95% CI: 6.16–22.23; p=0.001).
The investigators concluded that the regimen demonstrated “no significant detriment to overall QoL during treatment”.
Presentation details
| Title | Health-related quality of life (HRQoL) during neoadjuvant treatment with eftilagimod alfa, pembrolizumab and radiotherapy in patients with soft tissue sarcoma (STS) – results from EFTISARC-NEO trial |
| Presentation number | 3788eP |
| Format | ePoster |
| Availability | From October 23, 2026, 8:00 AM CEST |
| First author | Paweł Teterycz, M.D., Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland |
The ePoster is available on the Posters & Publications page of Immutep’s website.
Marc Voigt, CEO of Immutep, said: “People with soft tissue sarcoma who face surgery are already dealing with significant challenges. A treatment given before surgery should ideally work against the tumour without taking more away from their daily lives. These results suggest that patients receiving efti with pembrolizumab and radiotherapy maintained their quality of life during treatment, and after surgery reported less fatigue and better role and social functioning. We are grateful to the patients and investigators in Warsaw who made this study possible.”
About EFTISARC-NEO
EFTISARC-NEO is an investigator-initiated Phase II trial evaluating efti in combination with 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 (clinicaltrials.gov: NCT06128863). In October 2025, Immutep announced the trial met its primary endpoint. In April 2026, efti received Orphan Drug Designation in STS from the U.S. Food and Drug Administration (FDA).
About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals and cytokines that further boost the immune system’s ability to combat cancer.
Efti’s favourable safety profile has enabled various combinations, including with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in 1st line HNSCC and in 1st line NSCLC, and Orphan Drug Designation in STS, from the United States Food and Drug Administration (FDA).
About Immutep
Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases. 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding planned scientific presentations, anticipated clinical development, regulatory progress and the potential benefits of eftilagimod alfa (efti). 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, the ongoing root cause analysis, manufacturing, regulatory developments, the outcome of partnering discussions, and the Company’s ability to obtain additional funding and to advance its product candidates. Additional risks are described in the Company’s most recent Annual Report on Form 20-F and subsequent filings with the U.S. Securities and Exchange Commission and in announcements lodged with the ASX. 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.
Australian Investors/Media:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; [email protected]
U.S. Investors/Media:
Matthew Beck, astr partners
+1 (917) 415-1750; [email protected]
This announcement was authorised for release by the CEO of Immutep Limited.
Featured Image: Megapixl @ Shuttlecock