Primary goal achieved: Immutep reports strong Phase II results in sarcoma trial

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Immutep (ASX:IMM) CEO Marc Voigt delivers an update on the company’s recent clinical milestones, highlighting significant progress across multiple cancer indications. The focus of the presentation is the company’s Phase II trial in soft tissue sarcoma (STS), where its novel combination of eftilagimod alpha (efti), radiotherapy, and Merck’s KEYTRUDA® has met the primary endpoint.

Soft tissue sarcoma trial has met key goal

The EFTISARC-NEO trial, run by the Maria Sklodowska-Curie Center in Warsaw with 40 patients enrolled, has tested a chemotherapy-free regimen in the neoadjuvant setting (before surgery). Results have shown tumour hyalinisation/fibrosis in around 50% of patients—well above the 35% target and the historical control of 15%. This tissue transformation has been considered a surrogate marker for improved survival and lower recurrence risk. The trial has been largely funded by a Polish government grant, with Immutep supplying the drug.

High unmet need in a rare and diverse cancer

STS has remained a rare and heterogeneous disease, with ~100,000 new cases globally each year. Its five-year survival rate has dropped below 20% once metastasised, making early, effective intervention critical. The CEO has underscored the importance of improving surgical outcomes and long-term disease-free survival through immunotherapy.

Pipeline update: strong signals in lung and head and neck cancers

The update has also referenced recent positive data in first-line non-small cell lung cancer and head and neck cancer. Immutep has reported strong response rates and overall survival signals across these studies, and has now advanced toward a Phase III futility analysis, expected as early as late 2025 or early 2026.

Regulatory engagement and funding outlook

A meeting with the FDA has been planned regarding potential approval pathways for the company’s head and neck cancer programme. While the regulatory outcome has remained uncertain, the company has expressed optimism, citing its fast track designation and encouraging clinical data.

Immutep has remained well-funded, focused on cost discipline, and has leveraged external grants to offset trial expenses—particularly important in volatile market conditions. The company expects further data readouts and regulatory progress later in 2025.