First patient dosed in Immutep’s soft tissue sarcoma trial

The phase 2 study involves company’s eftilagimod alpha therapy

Immutep – a company focused on developing novel LAG-3 immunotherapies for cancer and autoimmune diseases – has announced that the first patient has been dosed in its EFTISARC-NEO trial.

The pivotal phase 2 study involves the company’s eftilagimod alpha (efti) therapy – a soluble LAG-3 protein and major histocompatibility complex (MHC) class II agonist, in combination with radiotherapy and the anti-PD-1 therapy Keytruda, for patients with soft tissue sarcoma.

It also becomes the first chemo-free trial to analyse efti in a neoadjuvant situation.

The study, which will treat up to 40 patients, is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology and is mainly financed using a grant from the Polish Medical Research Agency programme.

Principal investigator, Dr Paweł Sobczuk, was in no doubt about the importance of the trial: “Soft tissue sarcoma is a rare, aggressive disease in high need of new therapeutic approaches, and we are pleased to begin treating patients with this novel IO-IO-radiotherapy combination and look forward to evaluating the potential synergistic effects of this chemo-free therapy.”

He added: “In particular, efti’s sustained activation of antigen-presenting cells, leading to proliferation of activated CD8+ T cells and elevated interferon-gamma levels, may transform the immunosuppressed tumour microenvironment of soft tissue sarcomas into one that enables immune checkpoint inhibitors like pembrolizumab to exert their anti-cancer effect.”

Chief security officer at Immutep, Frédéric Triebel, reflected: “The neoadjuvant setting gives us the opportunity to assess in the surgical specimen the changes in the tumour microenvironment induced by efti. New information arising from this innovative trial may further broaden the future clinical development of efti and, in the end, bring even greater benefit to patients.”

Soft tissue sarcoma represents a serious condition with high unmet needs and a poor prognosis. The prevalence of illness varies across regions, with approximately 23,400 cases annually and an incidence of 4.7 per 100,000 throughout Europe.