Landmark vaccine stops cancer returning in trial
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Thousands of patients could benefit from personalised jab produced by Moderna and Merck to keep people free of the disease A cancer vaccine personalised for each patient has succeeded in a large final-stage trial, raising hopes that a new generation of tailor-made treatments could benefit thousands of people. The experimental vaccine, developed by Moderna and Merck, was given to patients with high-risk melanoma, a type of skin cancer, after they had surgery. The vaccine, named Intismeran, was accompanied by Keytruda, an immunotherapy drug already prescribed by the NHS for a dozen types of cancer. The companies said the combination, compared with Keytruda alone, significantly extended the time patients remained free of cancer and also reduced the risk of the disease spreading to other organs. Moderna and Merck are testing similar personalised vaccines for lung, bladder and kidney cancers. Lung cancer trials have reached the final stage 3 phase, while kidney and bladder studies are in phase 2. The hope is that the technology can work across many tumour types. Researchers will want to see a more detailed breakdown of the results. However, shares in both companies surged in New York. Stéphane Bancel, the Moderna chief executive, said that the latest results marked “a pivotal moment for the field of cancer research”. He added: “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.” Professor Marco Gerlinger, of the Barts Cancer Institute, said: “I think it is fair to call it a breakthrough as it is the first phase 3 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.” In the UK, half of people with melanoma skin cancer die within a year of diagnosis if it is spotted at stage 4. The disease claims about 2,300 lives in total each year. More than 1,000 patients took part in the phase 3 trial after having melanomas surgically removed. The patients had high-risk stage 2, 3 or 4 melanoma, meaning they ranged from having large but localised tumours to cancers that had spread to other parts of the body. Although the companies have not released detailed results, they said the study met both its principal goal of improving recurrence-free survival and an important secondary goal of preventing the cancer from spreading. Cancer is becoming more common but fewer people are dying from it The vaccine uses mRNA, a technology that became well known through Covid vaccines. Unlike conventional vaccines, which are usually designed to prevent infection, the treatment is made individually for each patient. After surgery, scientists analyse a sample of the tumour to identify mutations unique to its cancer cells. They then encode selected targets into strands of mRNA, producing a vaccine designed to teach the immune system — particularly cancer-killing T cells — to recognise and attack any tumour cells that remain. Manufacturing each dose takes about six weeks. Patients begin treatment with Keytruda while their personalised vaccine is prepared. Earlier results from a smaller study found that the combination reduced the risk of melanoma returning or patients dying by 49 per cent and cut the risk of the cancer spreading to other parts of the body or the patient dying by 59 per cent compared with Keytruda alone. Important questions remain, including the size of the benefit, side-effects and the cost and complexity of manufacturing a bespoke vaccine for every patient. Nevertheless, the trial appears to represent a milestone. If regulators approve the treatment, Moderna has said it hopes it could reach patients as early as next year. Moderna and Merck will provide more details at a medical conference later this year. High costs could limit the drug’s accessibility if it is eventually approved by regulators. Professor Georgina Long of the University of Sydney, who is the study’s principal investigator and also medical director of the Melanoma Institute Australia, said the results represented “a landmark moment”. She added that the combination of Intismeran and Keytruda “has the potential to establish a new treatment paradigm” that would help patients remain cancer-free for longer. Dr Lennard Lee of the University of Oxford, a consultant oncologist who is advising the NHS and the government on cancer vaccines, said that it was an “important moment that scientists have been working towards for many years”. He added: “There is also a wider story here about what happened after the pandemic. In 2020, enormous global investment accelerated mRNA technology, vaccine science and manufacturing, and it started in the United Kingdom. The question afterwards was whether that capability could be redirected towards other major diseases. “In 2022, the UK made an early strategic decision to pursue that opportunity in cancer, launching a national cancer vaccine advance to accelerate clinical trials of mRNA cancer vaccines. Since then, the UK has developed into one of the world’s leading environments for cancer vaccine trials.” One mRNA vaccine trial now active in the UK involves patients with high-risk stage 2 or stage 3 colon or rectal cancer whose tumours have been surgically removed, but who still have traces of tumour DNA detectable in their blood, suggesting a high chance that the cancer could return. BioNTech developed that treatment. The first English patient received the vaccine in Birmingham in 2024 through the Cancer Vaccine Launch Pad, a scheme for connecting eligible NHS cancer patients with clinical trials of new cancer vaccines. British patients are also involved in personalised vaccine trials for pancreatic cancer, being run by BioNTech and Genentech. Rhys Blakely