Personalised mRNA vaccine intismeran cuts melanoma recurrence risk by 42% in phase 3 trial
The phase 3 INTerpath-001 trial found that adding the personalised mRNA vaccine intismeran to pembrolizumab cut the risk of melanoma recurrence or death by 42% — a world-first for cancer vaccines.
A personalised mRNA vaccine has succeeded in a phase 3 cancer trial for the first time, cutting melanoma recurrence-or-death risk by 42% when added to immunotherapy, results released on Thursday showed.
INTerpath-001 enrolled 1,137 patients across 157 sites whose high-risk stage IIB–IV melanoma had been surgically removed. Two-thirds received nine doses of intismeran (V940/mRNA-4157) — Moderna and Merck’s vaccine built from up to 34 neoantigens per patient’s tumour — plus pembrolizumab (Keytruda); the rest got pembrolizumab alone.
After 24.6 months, the vaccine arm had a 42% lower risk of recurrence or death (HR 0.58; 95% CI 0.45–0.75; p<0.001) — 58% among patients recurrence-free beyond six months. Distant metastasis or death fell 38%. No new safety signals; transient low-grade effects — injection-site pain, headache and chills.
Professor Georgina Long AO, global principal investigator at Melanoma Institute Australia, called the findings “a foundational shift in our approach to cancer… This has not been achieved before in the history of cancer drug development.”
Experts were cautious. Dr Lennard Lee of Oxford, not involved in the trial, told The Times it was “a major breakthrough for cancer vaccine research”. Professor Alan Melcher of the Institute of Cancer Research called the results “very impressive… an important proof of principle for the field, although we shouldn’t get ahead of the evidence”.
Full data go to the ESMO Congress in Madrid on Saturday; accepted for publication in the New England Journal of Medicine, the companies are engaging regulators. The treatment is not yet available.
Sources
- Melanoma Institute Australia: https://melanoma.org.au/news/personalised-cancer-vaccine-cuts-risk-of-melanoma-recurrence/
- The Times (UK): https://www.thetimes.com/uk/healthcare/article/custom-cancer-vaccine-melanoma-gt9m9b99l
- CancerNetwork (detailed results): https://www.cancernetwork.com/view/intismeran-plus-pembrolizumab-reduces-recurrence-risk-in-resected-melanoma
- AJMC: https://www.ajmc.com/view/merck-moderna-cancer-vaccine-cuts-melanoma-recurrence-risk-by-42-
- SciMex expert reaction: https://www.scimex.org/newsfeed/expert-reaction-melanoma-vaccine-reduces-death-or-cancer-recurrence-by-42-percent
- UK Science Media Centre: https://www.sciencemediacentre.org/expert-reaction-to-top-line-results-from-the-phase-3-interpath-001-trial-looking-at-an-mrna-vaccine-intismeran-in-combination-with-pembrolizumab-for-patients-with-completely-resected-stage-iib-iv-me/
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