About 12 More in 100 Melanoma Patients Stay Cancer-Free With a Custom Vaccine
Adding a vaccine tailored to each patient's tumour improved outcomes after surgery for high-risk melanoma. Independent researchers see a possible approval next year, while price could become a barrier to access.
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A personalised cancer vaccine improved recurrence-free outcomes after melanoma surgery in a large phase 3 trial, bringing treatment designed around each patient's tumour closer to clinical use.
At 24 months, 82.2% of patients given Moderna and Merck's vaccine alongside pembrolizumab were alive without their cancer returning, compared with 70.0% given pembrolizumab alone. That is a difference of 12.2 percentage points, or roughly 12 more people in every 100 alive and recurrence-free at that point.
The vaccine, intismeran autogene, targets mutations in an individual patient's cancer. The trial tested it after surgeons had removed the visible tumour, when people with high-risk melanoma still face the possibility that cancer will return or spread. Pembrolizumab, an immunotherapy already used in this setting, was given to both groups.
Independent researchers expect the findings could lead to approval next year. Alan Melcher, a cancer researcher quoted by New Scientist, said approval could come quickly and that next year sounded reasonable. Rebecca Lee, who was not involved in the trial, said approval in the US, Europe and the UK next year was highly likely.
Those are expert expectations, not regulatory decisions. The companies say they are engaging with regulators, but no firm approval timetable has been established. Nor do the results yet show that patients live longer overall, because the survival data need more follow-up.
