Maignant melanoma

NEO-TIL; A Multicenter Clinical Initiative Conducted by The Swedish Melanoma Study Group

Optimised treatment of malignant melanoma will save more patients

With the help of immunotherapies, many people with metastatic melanoma can live long lives, but not all. Swedish researchers will now try to save more patients by optimising how new and innovative treatments are used. In a flagship project funded by the Sjöberg Foundation, they will explore how best to attack malignant melanoma.

Fifteen years ago, curing advanced melanoma was a utopian vision, thanks to immunotherapies, almost half of all patients are now alive after five years.

“There was total euphoria when we got immunotherapies. It was a huge step forward, but we cannot rest on our laurels, as half of all patients still die from the disease,” says Hildur Helgadottir, docent and chief physician at Karolinska University Hospital.

Along with other researchers from the Swedish Melanoma Study Group, she will now conduct a large clinical trial, SWE-NEO, on patients who have spread malignant melanoma and where the tumours are still operable. The aim is to better understand how doctors can use new treatments to save more patients.

Relatively recently, researchers realised that immunotherapies work better if patients receive them before surgery. Immunotherapies release the immune system’s brakes, leaving immune cells freer to attack tumour cells. However, for the therapy to work, the immune cells must learn to recognise the cells they are supposed to destroy. If the tumour is still in the body, immune cells get trained to eradicate the malignant cells.

“Previously, patients with melanoma that had spread to the lymph nodes were operated directly, but we’ve realised that introducing immunotherapy before surgery may provide a golden opportunity,” says Helgadottir.

In SWE-NEO, researchers will allocate patients to two different groups; both will receive immunotherapy before surgery, but one group will be treated with a combination of two different immunotherapies. Previous studies on malignant melanoma, where the disease is so spread that it is inoperable, have shown that combination therapy has a powerful effect, but it also causes more serious side effects and is more expensive.

“We are the first in the world to study how treatment with one immunotherapy drug works compared to that specific combination, when given before surgery. It’s important to know the optimal level – is it worth giving the extra treatment or will patients just experience more side effects,” says Helgadottir.

In the next step, patients who relapse despite immunotherapy and surgery will receive TIL therapy. This is a new form of treatment in which laboratory staff isolate special immune cells, tumour-infiltrating lymphocytes (TILs), from the patient’s tumour. The immune cells then multiply before being reintroduced to the patient’s bloodstream, where they can launch a powerful attack on the tumours.

Unfortunately, TIL therapy is time consuming. It takes up to six weeks to grow all the cells needed to eradicate metastases.

“During that time, some of the patients become very ill. We know from experience that many people will never be able to get their TILs,” says Helgadottir.

Therefore, one important aim of SWE-NEO is to find biomarkers that can reveal which patients will need TIL therapy, so the treatment can be started at an earlier stage of the disease.

“The more time that passes, the better the tumour becomes at evading the immune system. So the earlier you take action, the more active the immune system is.”

To find these biomarkers, the researchers will collect a variety of samples from the patients during the study. They will also create advanced animal models of patients’ tumours and use them to investigate the best time to collect TILs from a tumour. Are the immune cells most powerful in the early stages of the disease? Or after a round of immunotherapy? Or should they be collected as close to the treatment as possible?

The Swedish Melanoma Study Group will also ensure that more hospitals can deliver TIL therapy, so that more patients can access the treatment, because its effect can be dramatic.

“Many people have experienced incredible effects, reversing the disease.”

The hope is that optimising TIL therapy could save more lives; the Swedish Melanoma Study Group’s long-term aim is that no one should die from malignant melanoma.

“We have made great strides, but there is the potential to do even more and make things even better. We haven’t yet reached the end of the road,” says Helgadottir.

Main applicant: Hildur Helgadottir, docent and chief physician, Karolinska Institutet and Karolinska University Hospital.

Co-applicants: Göran Jönsson, professor, Lund University

Lars Ny, professor and chief physician, University of Gothenburg and Sahlgrenska University Hospital

Jonas Nilsson, professor, University of Gothenburg

Roger Olofsson Bagge, professor and chief physician, University of Gothenburg and Sahlgrenska University Hospital

Ana Carneiro, docent and chief physician, Lund University and Skåne University Hospital

Stina Wickström, docent, Karolinska Institutet

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