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In brief

• Merck and Moderna report a personalized mRNA vaccine given with Keytruda cuts melanoma recurrence or death risk by 42%.
• Distant metastasis risk fell by 38%, based on a trial of 1,137 patients with just under 25 months of follow-up.
• No clear overall survival benefit has been shown yet, and the companies plan talks with regulators.

Trial results

The two companies say a personalized mRNA vaccine called intismeran autogene, given after surgery alongside the immunotherapy drug Keytruda, reduced the risk of melanoma returning or patients dying by 42% compared with Keytruda alone (Szczepionka mRNA na raka przed kluczowym testem. Moderna i Merck odkrywają karty – Strefa Inwestorów) (Nowa terapia czerniaka. Szczepionka mRNA zmniejszyła ryzyko nawrotu – Deutsche Welle) (Experimental mRNA vaccine cuts risk melanoma returns by 42% | CNN – cnn.com). The trial, known as INTerpath-001, enrolled 1,137 patients with stage IIB to IV melanoma (Szczepionka mRNA na czerniaka działa. Ryzyko nawrotu spadło o 42 proc. - GeekWeek w INTERIA.PL – geekweek.interia.pl).

The 42% figure covers recurrence or death. Separately, the risk of distant metastases fell by 38% over roughly two years. Follow-up so far is just under 25 months, and the trial has not yet shown a clear overall survival benefit.

Next steps

Merck said it will begin talks with regulators based on these data, though it has not specified what outcome it expects from those discussions. A positive decision would make this the first personalized mRNA cancer vaccine approved in the United States or the European Union.

The results were presented at the European Society for Medical Oncology congress in Madrid, and the paper has been accepted by The New England Journal of Medicine. Earlier topline announcements in August had already signaled the trial's success, pushing Moderna's shares higher.

Key figures

| Measure | Result | |---|---| | Risk of recurrence or death | 42% lower | | Risk of distant metastases | 38% lower | | Patients enrolled | 1,137 | | Follow-up so far | Just under 25 months |

What remains open

The overall survival data are not yet mature, so it is unclear whether patients live longer. Full publication will show more detail on side effects and subgroup results.