Experts hail 'pivotal moment' as cancer jab shown to reduce risk of death and late-stage melanoma returning

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The jab, which is custom-built for each person in just a few weeks, works by telling the body to hunt down cancer cells and prevent the deadly disease from coming back.

A stage two trial of the jab found it dramatically reduced the risk of the cancer returning in melanoma patients.

Topline results from the phase three trial of more than 1,000 patients show the jab, in combination with MSD’s immunotherapy Keytruda medicine, resulted in a 49% reduction in the risk of recurrence or death.

The results, which are yet to be peer-reviewed and published in an academic journal, also show a 59% reduction in the risk of “distant metastasis” – where the cancer has spread to a different organ or tissues away from the original tumour – or death.

Experts hailed the results as a breakthrough and said the findings show “proof of principle that personalised cancer vaccines work” and that these could be applied to other cancers, such as bowel cancer.

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Professor Georgina Long, the study’s principal investigator from the Melanoma Institute Australia, chair of Melanoma Medical Oncology and the University of Sydney, said: “Today’s results represent a landmark moment for adjuvant melanoma treatment.

“This is the first phase three study to show that intismeran, a treatment designed based on the unique mutational ‘fingerprint’ of a patient’s own tumour, given in combination with pembrolizumab, can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to Keytruda alone.”

Dr Dean Li, president of Merck Research Laboratories, added: “We believe individualised neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated.

“Together with Moderna, we look forward to presenting data from INTerpath-001 at an international medical meeting and sharing with regulatory authorities.”

Stephane Bancel, chief executive of Moderna, added: “These phase three findings represent a pivotal moment for the field of cancer research.

“For many years, the idea of creating an mRNA treatment designed specifically for an individual patient’s cancer was aspirational.

“We are now helping turn that vision into a reality.”

Known as mRNA-4157 (V940), the jab is created to target tumour neoantigens, which are expressed by tumours in a particular patient.

These are markers on the tumour which can potentially be recognised by the immune system.

The jab carries coding for up to 34 neoantigens and activates an anti-tumour immune response based on the unique mutations in a patient’s cancer.

In order to create the jab, a sample of tumour is removed during the patient’s surgery, followed by DNA sequencing and the use of artificial intelligence.

The result is a personalised anti-cancer jab which is specific to the patient’s tumour.

British patients were among the first in the world to be enrolled in the latest trial at University College London Hospitals NHS Foundation Trust (UCLH).

Dr Lennard Lee, consultant medical oncologist, associate professor and senior national clinical adviser on cancer vaccines at the University of Oxford, said: “These findings are significant. This is the first positive phase three trial of an individualised neoantigen therapy and an mRNA-based cancer treatment.

“That makes this an important moment for a field that scientists have been working towards for many years.

“This was a large phase three randomised trial involving 1,137 patients with surgically removed, high-risk melanoma, and the trial met its primary endpoint.

“According to the topline announcement, patients receiving the personalised mRNA cancer vaccine alongside pembrolizumab had a statistically significant and clinically meaningful improvement in recurrence-free survival compared with pembrolizumab alone. The study also met the important secondary endpoint of distant metastasis-free survival.

“That is very encouraging. We should now look forward to seeing the complete data.”

Professor Marco Gerlinger, from Barts Cancer Institute, St Bartholomew’s Hospital, added: “I think it is fair to call it a breakthrough in the development of new cancer immunotherapies as it is the first phase three study that shows that a vaccine can protect against recurrences of one of the deadliest cancer types.

“This is certainly good news for patients with melanoma, but the study has much wider implications – it provides proof of principle that personalised cancer vaccines work.

“This is important as they can be designed against many different cancer types. I am hopeful that we will see similar successes of this technology in a range of cancer types, such as colon cancer, where a large study has been performed.”