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Moderna and Merck report first positive late-stage trial for personalized mRNA melanoma vaccine combined with Keytruda
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Moderna and Merck say their personalized mRNA melanoma vaccine, administered alongside Merck's Keytruda immunotherapy, significantly reduced cancer recurrence and spread in a late-stage trial of 1,137 patients.
This is the first positive late-stage trial result for an mRNA cancer vaccine and the first study to show that adding a treatment to Keytruda outperformed Keytruda alone. If regulators approve it, the therapy could reach patients as soon as next year, and similar mRNA approaches are already being tested against lung, breast, and pancreatic cancers.
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The trial enrolled 1,137 high-risk patients with stage IIB-IV melanoma that had been surgically removed, randomized to receive up to nine doses of Keytruda plus the personalized vaccine or Keytruda alone for about one year.
A mid-stage trial previously showed the combination reduced the risk of recurrence or death by 49% after five years, and no new safety signals have emerged in the late-stage study.
Moderna shares more than doubled on the news, adding approximately $30 billion to its market value.
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