Immutep Announces Release of CTOS 2026 Abstract Reporting First Survival Data from EFTISARC-NEO

The preliminary survival results follow a previously met primary endpoint; disease-free and overall survival follow-up remains ongoing.

Rhea-AI Summary

Immutep (IMMP) released the first survival data from EFTISARC-NEO, a Phase II trial in patients with resectable soft tissue sarcoma. The trial evaluates efti plus pembrolizumab and radiotherapy before surgery. In 38 evaluable patients, 12-month disease-free survival was 81.1%, local recurrence-free survival was 94.1%, and distant metastasis-free survival was 86.2%. Median follow-up was 19.1 months, with an April 30, 2026 data cutoff.

These are preliminary secondary-endpoint results; disease-free and overall survival follow-up continues. The trial previously met its primary endpoint, with median tumour scarring of 51.5% versus a 35% target. Quality of life showed no significant deterioration during treatment and improved significantly after surgery. Efti received FDA Orphan Drug Designation for this cancer in April 2026. Further analyses will be presented on November 19, 2026 at CTOS.

6 points · 1 major

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointPrimary endpoint met: median tumour scarring was 51.5%, versus 35% targeted and approximately 15% historically with radiotherapy alone.
• Moderate pointTwelve-month disease-free survival was 81.1% in 38 evaluable patients after median follow-up of 19.1 months.
• Moderate pointTwelve-month local recurrence-free survival was 94.1% in the same 38 evaluable patients.
• Moderate pointTwelve-month distant metastasis-free survival was 86.2% in the same 38 evaluable patients.
• Minor pointQuality of life did not significantly deteriorate during treatment and improved statistically significantly after surgery.
• Minor pointFDA Orphan Drug Designation granted to efti for soft tissue sarcoma in April 2026.

Negative

• Minor pointSurvival results remain preliminary; disease-free and overall survival follow-up is ongoing.
• Minor point. Forward-looking: it has not happened yet and may not happen.Possible associations with better disease-free survival for immune-cell infiltration and tumour scarring require longer follow-up.

Key Figures

Median follow-up: 19.1 months Evaluable patients: 38 patients 12-month DFS: 81.1% +2 more

Median follow-up

19.1 months

EFTISARC-NEO survival analysis

Evaluable patients

38 patients

Survival analysis population

12-month DFS

81.1%

Disease-free survival

12-month LRFS

94.1%

Local recurrence-free survival

12-month DMFS

86.2%

Distant metastasis-free survival

Historical Context

2 past events · Latest: Oct 23

2 events

1. Oct 23

   Quality-of-life data

   24h Move

   +0.9%

   EFTISARC-NEO quality-of-life results showed improvement after surgery.

2. Oct 29

   Primary endpoint result

   24h Move

   +0.3%

   EFTISARC-NEO had met its primary endpoint, with median tumour hyalinisation/fibrosis of 51.5%.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

disease-free survival, local recurrence-free survival, distant metastasis-free survival, neoadjuvant therapy, +1 more

5 terms

disease-free survival medical

"12-month disease-free survival (DFS), local recurrence-free survival"

Disease-free survival measures the length of time after treatment during which a patient shows no signs or symptoms of the disease. For investors, it is a key clinical result because longer disease-free periods suggest a therapy is effective at preventing recurrence, which can drive regulatory approval, market demand and revenue potential—think of it as how long a repaired item runs without breaking down.

local recurrence-free survival medical

"local recurrence-free survival (LRFS) and distant metastasis-free survival"

Time measured from a defined starting point in a clinical study (commonly surgery or randomization) to the first documented return of cancer at the original site or in the immediately adjacent area. Patients who have not had a local return by their last follow‑up are treated as censored at that date; trial protocols may differ on whether distant recurrences or death are counted as events or are censored, so the precise event definition should be checked in the study protocol. Local recurrence‑free survival differs from disease‑free survival (which includes any recurrence or new cancer) and from overall survival (which counts death from any cause).

distant metastasis-free survival medical

"distant metastasis-free survival (DMFS) rates were 81.1%, 94.1% and 86.2%"

The length of time after treatment during which a patient shows no return of cancer in distant organs or sites; it measures how long the disease stays confined rather than spreading to places like the liver, lungs or bones. Investors watch this endpoint because it signals a therapy’s ability to prevent dangerous recurrence, influences regulatory approval and market value, and helps predict long-term patient benefit—like timing how long a repaired dam holds back floodwater.

neoadjuvant therapy medical

"as neoadjuvant therapy showed promising preliminary long-term outcomes"

Neoadjuvant therapy is medicine given before the main treatment—usually drugs, radiation, or both—aimed at shrinking a tumor or improving surgical outcomes. For investors it signals a strategic step in a drug’s development and commercial path: successful neoadjuvant results can make a treatment easier to use, expand its approved indications, and increase market value much like priming soil before planting improves the eventual harvest.

tumour-infiltrating lymphocytes medical

"high infiltration by tumour-infiltrating lymphocytes (TIL)"

Immune cells, mainly T lymphocytes, that have migrated from the blood into a solid tumour and are found among or next to the cancer cells; they show whether the body's immune system is recognising the tumour and can include various subtypes with different roles. Clinically, tumour-infiltrating lymphocytes (TILs) can be analysed to assess tumour-immune interaction and can be isolated, expanded outside the body and given back to a patient as a form of adoptive cell therapy, but their presence and activity vary widely between tumours and patients.

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• 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

FAQ

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What did Immutep's EFTISARC-NEO trial show about survival?

Among 38 evaluable patients, 12-month disease-free survival was 81.1%, local recurrence-free survival was 94.1%, and distant metastasis-free survival was 86.2%. Median follow-up was 19.1 months at the April 30, 2026 data cutoff. These preliminary results concern secondary endpoints; follow-up for disease-free and overall survival continues.

When will Immutep present updated EFTISARC-NEO analyses?

Further analyses will be presented in a poster discussion session on November 19, 2026 at the CTOS Annual Meeting in Seoul, South Korea. The poster with updated data will be available on Immutep's Posters & Publications webpage after the presentation.

How is Immutep's EFTISARC-NEO trial designed and funded?

EFTISARC-NEO is an investigator-initiated, open-label Phase II trial led by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw. A Polish Medical Research Agency grant primarily funds the trial, with Immutep supplying efti. Forty patients were enrolled, and enrolment finished in January 2025.