Immutep reports positive initial clinical data from EFTISARC-NEO study

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Immutep (ASX:IMM) has announced initial encouraging data from EFTISARC-NEO, a Phase 2 investigator-initiated trial of eftilagimod alpha in combination with radiotherapy, a standard-of-care treatment, plus MSD's KEYTRUDA (pembrolizumab) for patients with soft tissue sarcoma (STS).

The EFTISARC-NEO study is the first to evaluate efti in a neoadjuvant setting, which takes place before intended surgery, and the first to combine efti with radiotherapy.

The company said the triple combination revealed no new safety findings and was well tolerated in the first six patients who completed the 10 weeks of treatment, followed by surgery 2-3 weeks later.

"Initial efficacy data is very encouraging with 4 of 6 patients (67 per cent) having near-complete responses according to EORTC-STBSDG, which measures responses via tissue pathology after surgery," said the company.

Dr Frédéric Triebel, Immutep’s chief scientific officer, said, “We are pleased to see these early results from EFTISARC-NEO, which has allowed efti for the first time to be clinically evaluated in a non-metastatic cancer setting. The ability to evaluate tumour specimens is helping elucidate the significant anti-cancer immune response efti drives through its direct maturation and activation of antigen-presenting cells as an MHC Class II agonist. If the positive trend of strong pathological responses continues in this rare orphan disease, we will pursue all available avenues to bring this innovative therapy to soft tissue sarcoma patients in need of new, effective therapies in an expeditious manner.”

The open-label EFTISARC-NEO study will treat up to 40 patients. It is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw.