A personalized mRNA vaccine developed by Moderna with Merck reduced the risk of melanoma returning or causing death when added to Keytruda, Merck’s established immunotherapy, in a Phase 3 trial. The study enrolled 1,137 people with stage IIB-IV melanoma that had been surgically removed; participants were assigned in a 2-to-1 ratio to receive the vaccine plus Keytruda or Keytruda plus placebo. The vaccine, intismeran, is designed individually by identifying mutations in a patient’s tumor and encoding up to 34 of them in synthetic mRNA, prompting the immune system to target cancer cells.
After two years, 82 percent of patients receiving the vaccine combination were alive without recurrence, compared with 70 percent receiving Keytruda alone - a 42 percent reduction in the relative risk of recurrence or death. The combination also reduced the risk of distant metastasis or death by 38 percent: 88.5 percent remained alive without distant spread, versus 80 percent in the comparison group. The benefits were smaller than those reported in an earlier five-year Phase 2 study, but the companies describe this as the first Phase 3 trial to show a meaningful improvement over Keytruda alone on both measures. They are discussing approval with regulators, and the full results have been accepted for publication in the New England Journal of Medicine.
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