• Immutep shares promising early results from Phase 2 trial on soft tissue sarcoma (STS)
  • This trial is the first of its kind, and evaluates IMM’s lead drug, efti
  • STS is a rare cancer with limited treatment options


The clinical stage immunotherapy focused biotech, Immutep (ASX:IMM), has announced initial encouraging data from EFTISARC-NEO, its Phase 2 investigator-initiated trial of eftilagimod alpha (efti).

The trial is studying the combination of efti with radiotherapy and standard-of-care treatment, KEYTRUDA (pembrolizumab), for patients with soft tissue sarcoma (STS).

The EFTISARC-NEO study is the first study to evaluate efti in a neoadjuvant (administration of therapeutic agents before intended surgery), and the first to combine efti with radiotherapy.

The neoadjuvant setting is important because it lets doctors see how this treatment combo affects the tumour environment before surgery.

So far, six patients have finished the treatment and had surgery, and all have tolerated this triple combination well with no new safety concerns.

Initial results are promising: four out of six patients had very good responses to the treatment, which is unusual for this type of cancer especially with standard therapeutic approaches including radiotherapy.

“The initial pathologic responses from this novel combination are very encouraging and supportive of the potential synergistic effects of this new therapeutic approach,” said principal investigators of the trial, Katarzyna Kozak and Paweł Sobczuk.

“Indeed we have seen a high degree of hyalinization/fibrosis in the surgical samples which we rarely see with standard treatments. We look forward to continuing this study.”


No other treatment options for STS

The Phase 2 trial will treat up to around 40 patients, and is being carried out by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, where it is mainly being funded by a grant from the Polish government.

The main goal of the trial is to see how well the treatment works by looking at how much of the tumour has changed (measured by how much hyalinization/fibrosis there is) when the patients have surgery.

The fewer live tumour cells and the more hyalinization/fibrosis, the better the treatment is considered.

Meanwhile, soft tissue sarcoma (STS) is a rare type of cancer that currently does not really have any treatment options.

The cancer usually starts in soft tissues (muscle, tendons, fat, lymph and blood vessels, and nerves), but can develop anywhere in the body such as the arms, legs, chest, and abdomen.

The number of new cases each year varies by location, with about 23,400 cases in Europe and 13,400 in the US.

In Europe, around 4.7 out of every 100,000 people get STS each year. In the US, about 5,140 people die from STS annually.


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