Immutep Cancer Combo Keeps Sarcoma Patients Well and Cuts Fatigue After Surgery

Immutep's EFTISARC-NEO quality of life data from ESMO 2026 show patients held steady on efti, pembrolizumab and radiotherapy, then reported a 6.0-point summary score gain and sharply lower fatigue after surgery.
By Josua Ferreira -
  • Quality of life stayed stable through neoadjuvant efti, pembrolizumab and radiotherapy, with no statistically significant deterioration on any measured scale.
  • After surgery, the QLQ-C30 summary score rose 6.0 points (p=0.008), role functioning rose 12.7 points and fatigue fell by up to 14.2 points (p=0.001).
  • The data build on a primary endpoint of 51.5% median tumour hyalinization/fibrosis against a 35% target (p<0.001) in 38 evaluable patients.
  • Efti received FDA Orphan Drug Designation in soft tissue sarcoma in April 2026, adding a regulatory layer to the clinical data.
  • Immutep targets registration-directed studies in first-line HNSCC and neoadjuvant soft tissue sarcoma, with starts in the second half of calendar 2027.
Summarise with AI:

Quality of life data presented at ESMO 2026

Immutep (ASX: IMM; NASDAQ: IMMP) announced health-related quality of life (HRQoL) data from the investigator-initiated EFTISARC-NEO Phase II trial on 23 October 2026. The data are being presented as an ePoster (number 3788eP) at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain, running 23 to 27 October 2026.

Quality of life remained stable during neoadjuvant treatment with eftilagimod alfa (efti), pembrolizumab and radiotherapy, with a statistically significant improvement after surgery. The findings add tolerability data to the previously reported primary endpoint result in patients with resectable soft tissue sarcoma (STS).

Key findings: stable during treatment, better after surgery

Headline results

The announcement reported four key findings from the HRQoL analysis:

  • 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 improved by 6.0 points after surgery (95% CI: 1.80 to 10.19; p=0.008).
  • Role functioning improved by 12.7 points (p=0.02) and social functioning by 8.1 points (p=0.02) after surgery.
  • Patient-reported fatigue was statistically significantly lower than at baseline after surgery, by up to 14.2 points (p=0.001).
Measure Change after surgery 95% CI p-value
QLQ-C30 summary score 6.0 points 1.80 to 10.19 0.008
Role functioning 12.7 points 2.31 to 23.09 0.02
Social functioning 8.1 points 1.63 to 14.56 0.02
Fatigue (lower than baseline) By up to 14.2 points 6.16 to 22.23 0.001

The investigators concluded that the regimen demonstrated:

Investigator conclusion

“no significant detriment to overall QoL during treatment”

Marc Voigt, CEO of Immutep

“…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…”

Study design

Patient-reported outcomes were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Assessments took place at baseline, every 6 weeks during treatment and every 12 weeks after treatment.

EFTISARC-NEO Trial Protocol and Assessment Flow

The trial enrolled 40 patients, of whom 38 were evaluable for the primary endpoint. All patients completed the questionnaire at baseline, and between 29 and 38 patients completed it at each subsequent assessment.

HRQoL is a secondary endpoint of the trial. EFTISARC-NEO is led by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, and the first author of the ePoster is Paweł Teterycz, M.D.

Why quality of life matters in neoadjuvant sarcoma treatment

Neoadjuvant treatment is therapy given before surgery. HRQoL measures how patients feel and function in day-to-day life, including factors such as fatigue and the ability to carry out normal roles.

For investors, tolerability data can matter because it may support patient and physician adoption and shape the overall profile of a combination therapy.

Efti is an MHC Class II agonist that activates antigen-presenting cells (APCs), which engage the adaptive and innate immune system. According to the company, its favourable safety profile has enabled combinations with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy.

Building on the primary endpoint and regulatory progress

The HRQoL results build on the primary endpoint, announced in October 2025. 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).

In April 2026, efti received Orphan Drug Designation in STS from the U.S. Food and Drug Administration (FDA). Efti also holds Fast Track designation in 1st line head and neck squamous cell carcinoma (HNSCC) and 1st line non-small cell lung cancer (NSCLC).

The trial is primarily funded by a grant from the Polish Medical Research Agency (clinicaltrials.gov: NCT06128863).

Taken together, the efficacy result, the tolerability findings and the FDA Orphan Drug Designation now sit alongside each other in the STS programme. The announcement does not outline next steps, trial timelines or development plans beyond these results.

The company has since outlined registration-directed development focused on two indications, first-line HNSCC and neoadjuvant soft tissue sarcoma, with study starts targeted for the second half of calendar 2027.

The ePoster is available on the Posters & Publications page of Immutep’s website.

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Frequently Asked Questions

What is the EFTISARC-NEO trial?

EFTISARC-NEO is an investigator-initiated Phase II trial testing eftilagimod alfa with pembrolizumab and radiotherapy before surgery in resectable soft tissue sarcoma. It enrolled 40 patients and is led by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw.

What did the Immutep EFTISARC-NEO quality of life data show?

Quality of life stayed stable during neoadjuvant treatment, with no significant deterioration on any measured scale. After surgery, the QLQ-C30 summary score improved by 6.0 points (p=0.008) and fatigue fell by up to 14.2 points (p=0.001).

What is neoadjuvant treatment in sarcoma?

Neoadjuvant treatment is therapy given before surgery. In EFTISARC-NEO, patients received efti, pembrolizumab and radiotherapy ahead of surgical removal of their soft tissue sarcoma.

How is health-related quality of life measured in cancer trials?

EFTISARC-NEO used the EORTC QLQ-C30 questionnaire, completed at baseline, every 6 weeks during treatment and every 12 weeks afterwards. It scores areas such as fatigue, role functioning and social functioning.

What regulatory milestones has Immutep's efti reached in sarcoma?

Efti received FDA Orphan Drug Designation in soft tissue sarcoma in April 2026. It also holds Fast Track designation in first-line HNSCC and first-line NSCLC.

Josua Ferreira
By Josua Ferreira
Partnership Director
Josua Ferreira holds a Bachelor of Commerce in Marketing and Advertising and brings a background in publication, business development, and ASX market storytelling. He has worked with listed companies across the resource sector and broader market, combining sharp commercial instincts with a genuine commitment to keeping investors informed.
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