An innovative one-time treatment that harnesses a patient’s own immune system to fight advanced melanoma could help people with the deadly form of skin cancer live longer, researchers have suggested.
Lifileucel is a tumour-infiltrating lymphocyte (TIL) therapy, which involves isolating T cells – a type of white blood cell – from tumours and growing them in a lab before infusing them back into the patient where they can recognise and fight cancer.
In a C-144-01 trial involving 153 patients from Europe and the US, and led by The Royal Marsden NHS Foundation Trust, almost one in five patients with advanced melanoma survived for five years after receiving lifileucel, with tumours shrinking in the majority of cases.
Experts say it could become a “transformative option” for patients with advanced melanoma, or stage four melanoma, where the disease has spread to other parts of the body.
At a five-year follow-up, 19.7 per cent of patients were still alive with no new or delayed side effects.
The trial also found that tumours shrank in almost four out of five (79.3 per cent) patients, while one in 20 (5.9 per cent) showed no evidence of cancer.
Dr Andrew Furness, a consultant medical oncologist who led the trial at The Royal Marsden NHS Foundation Trust, said that while current forms of immunotherapy “have revolutionised the treatment of cancer in recent years, overall these benefit a minority rather than a majority of treated patients”.
“Results from this trial have shown that TIL therapy may change the outlook for people with advanced melanoma.”
Lifileucel is not yet approved for use in the UK, but was given the green light by the US Food and Drug Administration (FDA) for the treatment of advanced melanoma in February 2024.
Cancer Research UK estimates that there are about 20,800 new cases of melanoma diagnosed in the UK every year.
Trials are also looking at using the TIL therapy in combination with pembrolizumab, sold under the brand name Keytruda, for people with advanced melanoma.
Keytruda works by targeting and blocking a protein known as PD-L1, which is found on T cells, to help the immune system fight cancer more effectively.
Dr Furness added: “We’re continuing our research into the use of TIL therapy, as well as other forms of cellular therapy, across a broader spectrum of cancers including advanced lung, liver, ovary, skin and testicular subtypes as well as soft tissue sarcoma.”
Study co-author James Larkin, consultant medical oncologist at The Royal Marsden and professor of precision cancer therapeutics at The Institute of Cancer Research, London, said the “significant results offer a compelling case for TIL therapy as a transformative option in melanoma care”.
“The study demonstrates that for patients with few options left, a single infusion of lifileucel can provide a deep and lasting response and even complete remission in some cases. This marks a major advance in how we think about treating solid tumours.”
Zoe Phillips, 46, from Dorset took part in the TIL therapy trial at The Royal Marsden.
She was diagnosed with stage four melanoma in 2023 after previously being treated for skin cancer two years earlier.
“Six weeks after my first TIL therapy treatment, my scans showed that the tumours had completely disappeared,” Ms Phillips said.
“Before coming to The Royal Marsden, I was told that I would probably die, so hearing that my treatment had been successful was amazing. I was over the moon.
“I come back to the hospital regularly for pembrolizumab immunotherapy treatment and currently still have no evidence of cancer.”
Findings from the C-144-01 trial have been presented at the American Society of Clinical Oncology (Asco) annual meeting in Chicago.
