Results from the C-144-01 trial run by Iovance have just been reported at the 2025 international Amercian Society of Clinical Oncology (ASCO) conference in Chicago, showing that almost one in five patients with advanced (unresectable or metastatic) melanoma were still alive five years after receiving lifileucel, with the melanoma shrinking in almost four out of five patients on the trial.

Experts say this could become a “transformative option” for patients with melanoma, with some patients having a long –lasting effect from treatment.  

Dr Andrew Furness, the consultant medical oncologist who led the trial at The Royal Marsden NHS Foundation Trust, said:  

“Results from this trial have shown that TIL therapy may change the outlook for people with advanced melanoma.” 

Lifileucel was approved by the US Food and Drug Administration (FDA) for the treatment of advanced melanoma in February 2024. In the UK, lifileucel is currently going through a review process with the National Institute for Health and Care Excellence (NICE) with the results hoping to be published in December 2025. If approved, the NHS in England will be responsible for the review of the set-up of hospitals across England to be able to give this new innovative treatment. Lifileucel is a one-off infusion but requires a hospital stay of up to two weeks for the supportive medicines before and after the TILs therapy. 

Melanoma Focus CEO, Susanna Daniels said: 

“The 5-year results with this personalised cancer care in patients who have had a number of treatments for advanced melanoma are extremely encouraging. As a charity, we look forward to supporting the approval processes across the UK so that, once licensed, this treatment will be available for patients with advanced melanoma.”   

Esther Allen was diagnosed with stage 4 melanoma during 2009, in August 2024 she received TILs treatment:

“I accessed TILs in Israel in August 2024 as I had failed all treatments available to me in the UK.”

“Receiving TILs therapy means, that for me, I can now see a future. TILs therapy is important. It offers personalised tailored medicine and is potentially curative. My scans in March 2025 showed that I was clear of all metastatic disease.”

 For more information on TILs therapy, visit our page here. 

Additionally, you can access this publication from the Journal of Clinical Oncology: Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study

In clinical trials, patients were very happy with the under-the-skin injection, which takes 3-5 minutes to give every 4 weeks, and they generally preferred it to the intravenous drip of nivolumab which takes 30 to 60 minutes. The new injection was also shown to be as effective and with similar side effects to intravenous nivolumab.

For melanoma patients, the new under-the-skin nivolumab injection can be given alone or after receiving the combination with ipilimumab. The NHS expects subcutaneous nivolumab to be available in the UK from June onwards. Patients that are able to switch to the new nivolumab injection will have a discussion with their doctor before starting it. 

This faster treatment comes at no extra cost to the NHS thanks to an agreement between NHS England and the manufacturer Bristol Myers Squibb. 

Professor Sarah Danson, Clinical Co-Lead for Cancer in the VIP, explains:
“Currently, we have several ways to treat cancer, including surgery, radiotherapy, chemotherapy, immunotherapy, hormonal treatments, and targeted drugs. While these methods benefit many, they don’t help all patients, and we are constantly seeking better solutions. Vaccinating against cancer, similar to how we vaccinate against infections, is a powerful concept, and we hope to integrate this into our treatment arsenal to improve outcomes for patients.”

The VIP brings together cancer vaccine research experts to guide the design and setup of clinical trials, ensuring that trials are not only well-suited to the UK’s health system but also strategically distributed across NHS sites to maximise patients’ access to these trials.

The VIP’s approach ensures early identification of challenges, promotes collaboration, and fosters an environment where both healthy volunteers and cancer patients can take part in ground-breaking research.

To further support this initiative, NHS England has launched the Cancer Vaccine Launch Pad (CVLP), which collaborates with the VIP to identify cancer patients who may benefit from vaccine trials. As the CVLP expands across NHS Trusts, it helps identify individuals receiving cancer treatment in the NHS whose tumours could be tested for trial eligibility, helping personalised cancer vaccine treatments reach more people.

The VIP remains at the core of the UK’s efforts to advance vaccine science, pushing the boundaries of what is possible in cancer care.

By engaging with the public and streamlining clinical trial processes, the VIP is shaping the future of cancer treatment and improving access to these innovative therapies.

For more information on personalised cancer vaccines, visit our page here.

• Nivolumab plus ipilimumab every 3 weeks for four doses, followed by nivolumab alone every 2 weeks (nivolumab alone can now be given 4 weekly) 
• Nivolumab every 2 weeks (it can now be given 4 weekly) 
• Ipilimumab every 3 weeks for four doses only.  

Treatment was continued until patients’ melanoma progressed (came back), they experienced unacceptable side effects, or if they no longer wanted to take part in the trial. 

The graph shows that more patients who have treatment with ipilimumab and nivolumab (the orange line on the graph) and nivolumab alone (the green line) are living longer. In fact, as these lines plateau (become flatter on the right-hand side), the overall survival or the amount of people alive after 10 years, is around 40% (40 out of every 100 patients) for patients who have had nivolumab and ipilimumab or nivolumab on its own.

Incredibly, these long-term trial results show that immunotherapy treatments can have a lasting effect in treating melanoma and many patients are living longer.  Treatment choices should take into account the potential side effects of immunotherapies that patients may experience. 

Pembrolizumab is another immunotherapy treatment that is thought to work in a similar way to nivolumab and is given every 3 or 6 weeks and this treatment also results in many patients living alongside their melanoma (similar to nivolumab). A newer combination of treatment with relatlimab-nivolumab was recently approved, and it is thought that long-term results will show that a similar number of patients will live long-term like with the combination of ipilimumab and nivolumab. 

Despite the progress made in the treatment of advanced melanoma, there are still some important questions to be looked at, including finding new treatments or new combinations of treatments with less possible side effects and also better options for patients who do not respond to current immunotherapy treatments. 

 By giving 2-3 doses of immunotherapy prior to surgery, however, not altering the total amount of immunotherapy treatment overall improves the event-free survival and the NADINA study had an additional element where no further adjuvant treatment is given in 59% of patients who had a major pathological response.

These neoadjuvant studies were not registration studies and these treatments are currently not available routinely to patients, so your specialist cannot offer them to you as yet on the NHS. Therefore oncologists are working with NHS England and the National Cancer Medicines Advisory Group (in Scotland) to adopt a change in practice as soon as possible in order to ensure best outcomes for our patients with treatments that are also cost effective to the NHS.

 Melanoma Focus’ Chairman, Dr Mark Harries said:

“I’m extremely encouraged by the data that shows that giving immunotherapy before surgery to patients who have operable disease spread from melanoma, seems to significantly improve outcomes over the current practice of giving immune therapy after surgery. The charity Melanoma Focus is lobbying and supporting oncologists to allow this treatment to be given in this setting for NHS patients.”

What are personalised cancer treatments?

A personalised cancer treatment takes into account the different characteristics of each person’s melanoma and uses this to make a very specific treatment to target, attack and kill their own melanoma cells.

What is an Individualised Neoantigen Treatment (INT)?

An INT is a type of personalised cancer treatment.

Scientists take cells from a person’s melanoma and look at them in a laboratory to identify the neoantigens, which are proteins on the tumour cells that the body’s immune system can recognise. The scientists can then create a treatment that when given back to the same patient can stimulate their body’s immune system to recognise these neoantigens on the melanoma cells’ surface so that it can attack and kill them.

There are different types of new technologies used to make INT’s and this trial will be using an mRNA -based INT. With mRNA being the messenger system which can instruct the body to make certain proteins.

This phase 3 clinical trial by MSD and Moderna will be the first of its kind looking at an mRNA-based INT to treat melanoma patients in the UK.

For more information on this news please see the announcement here

For more information on current clinical trials available to melanoma patients see our Melanoma TrialFinder.

And remember to keep checking back for news on this new trial which is hopefully planned to open in late 2023!

If you would like to take part, you can view the summary on the Melanoma TrialFinder to check whether you would be eligible to take part or see the OPTIC study official website for more details.

Melanoma TrialFinder

OPTIC study website

The OPTIC study researchers are currently interviewing patients with advanced melanoma but will want to speak to patients with earlier stage melanoma later in 2023 also, so do keep up to date with the Melanoma TrialFinder to check for new information.

…Research is also vital in determining what doesn’t work, so we can improve best practice and focus resources on providing healthcare that delivers the greatest benefit to patients. And research extends beyond clinical trials for new medicines to cover a range of activities – from a study into a new approach to radiation therapy, to work to explore how a particular disease could be prevented, or even an investigation to help mitigate the side effects of a new treatment.
Clinical research is all around us and helps to improve the quality of healthcare patients receive. Crucially, these benefits are felt by everyone, not just those participating in research. For example, data shows NHS trusts that are highly research active have better outcomes for patients across their services.

As we look to tackle today’s major healthcare challenges….we must double-down on our commitment to clinical research.
This is how we will identify the best treatments, the best technologies and the best techniques to improve the lives of our children and our grandchildren…”

>Read the full document here;