‘Bespoke’ mRNA vaccine significantly reduces risk of melanoma recurrence or death, clinical trial shows — SkimNews
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- Intismeran, a custom-made mRNA vaccine targeting genetic mutations unique to each patient's melanoma, combined with pembrolizumab cut the two-year risk of recurrence or death by 42% versus pembrolizumab alone in an Australian-led phase III trial of 1,137 patients run across 157 sites worldwide.
- Pembrolizumab — every trial patient received 12 months of the immunotherapy after melanoma surgery, and 82% of those who also received intismeran were alive and recurrence-free at two years, against 70% on pembrolizumab alone.
- Melanoma Institute Australia — medical director Georgina Long, the 2024 Australian of the Year, called the findings "a foundational shift in our approach to cancer" and will present them at the European Society for Medical Oncology congress in Madrid this weekend.
- New England Journal of Medicine has accepted the trial results for publication, though the paper still has to go through peer review.
- Jessamy Tiffen, acting deputy director of the Centenary Institute's Centre for Cancer Innovations and not involved in the research, said the vaccine targets up to 34 gene mutations unique to each patient, but a significant portion do not respond and only time will tell whether the benefit holds beyond two years.
- Christopher Sweeney, director of the South Australian immunoGENomics Cancer Institute at Adelaide University, said more research is needed in patients who have cancer that can be seen and in those not responsive to pembrolizumab.
- Drug manufacturers said it is too early to tell from the data whether the combination improved long-term survival, and intismeran faces further study and regulatory review before becoming standard melanoma treatment, a process that may take several years.
Why it matters: Adding intismeran to pembrolizumab lifted two-year recurrence-free survival from 70% to 82% for high-risk melanoma patients after surgery — the first positive phase III result for an individualised cancer vaccine. Patients still face further study and regulatory review before standard use, and manufacturers say the data cannot yet show whether overall survival improved.
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