Immutep reports success in soft tissue sarcoma trial

SYDNEY - Immutep Limited (ASX: IMM; NASDAQ: IMMP), an immunotherapy company specializing in cancer and autoimmune diseases with a market capitalization of $18.1 million, announced today that its Phase II EFTISARC-NEO trial has met its primary endpoint. The company’s stock has shown remarkable momentum, delivering a 120% return year-to-date according to InvestingPro data. The study tested a novel combination of eftilagimod alfa (efti) with radiotherapy and KEYTRUDA® (pembrolizumab) in a neoadjuvant setting for patients with resectable soft tissue sarcoma (STS).

The trial, conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, demonstrated a significant increase in tumour hyalinization/fibrosis, an early indicator of treatment response, compared to historical data from radiotherapy alone. Trading at $0.04 per share, with a 52-week range of $0.01 to $0.10, the stock has caught analysts’ attention, receiving the highest possible consensus recommendation according to InvestingPro data. This surrogate endpoint is associated with improved overall survival and recurrence-free survival in STS patients.

Investigators reported that the chemotherapy-free combination with efti exceeded the trial’s target, achieving a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients. The full enrolment of 40 patients was completed in January 2025, with detailed results expected to be presented at a medical meeting later this year.

Efti, Immutep’s proprietary soluble LAG-3 protein, acts as an antigen presenting cell activator, stimulating both innate and adaptive immunity in cancer treatment. It has been granted Fast Track designation by the FDA for use in head and neck squamous cell carcinoma and non-small cell lung cancer.

Soft tissue sarcoma represents an orphan disease with a significant unmet medical need. The American Cancer Society estimates there will be approximately 13,520 new STS cases and 5,420 deaths in the United States in 2025.

This advancement in STS treatment comes as part of Immutep’s broader efforts to develop novel immunotherapies. The company continues to evaluate efti for various solid tumors, including metastatic breast cancer. The information reported is based on a press release statement.

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