Lifestyle & Healthresearch summary
Moderna and Merck melanoma vaccine cuts risk of recurrence or death by 42% in Phase 3 trial
Moderna says it will 'go as fast as we can' toward FDA approval of intismeran, a customized mRNA therapy tested in melanoma.
This article is general information, not medical advice. Talk to a doctor or another qualified professional about your own situation.
The finding
A customized mRNA vaccine cut the risk of death or recurrence by 42% in a Phase 3 melanoma trial, when combined with Keytruda. [1] That result matters to patients with melanoma, because the presentation at the ESMO meeting was of the first Phase 3 study to successfully show that a customized mRNA-based therapy called intismeran could improve outcomes for them. [2]
After a median period of about two years, the vaccine plus pembrolizumab reduced the risk of cancer recurrence or death by 42% compared with pembrolizumab alone. [3] Michael Postow of Memorial Sloan Kettering called the main advance that fewer patients will see their cancer return. [3]
How the vaccine is built
The vaccine, intismeran autogene, is built around mutations unique to each patient's tumor. [1]
Moderna CEO Stéphane Bancel said the results reinforce the company's conviction that mRNA can change how cancer is treated at a basic level. [3]
A decade of work and a skeptical field
The intismeran program was a decade of Moderna research, boosted by a partnership with Merck. [2] Bancel said Moderna has been working on intismeran for 10 years. [2]
Most people in the field thought intismeran-style cancer vaccines would never work, and many people had tried cancer vaccines before. [2]
Moderna announced the trial's success in August without releasing data, and its stock rose over 300% after that announcement. [1]
What the results do not yet show
The findings do not yet include overall survival, according to Karen Knudsen, CEO of the Parker Institute for Cancer Immunotherapy. [3]
The results have been accepted for publication in the New England Journal of Medicine, according to Merck and Moderna. [3]
What it means for you
If you or someone you know has melanoma, the trial gives one concrete number: a 42% lower risk of recurrence or death with the vaccine plus pembrolizumab than with pembrolizumab alone. [3] Overall survival is not yet part of the findings, so that question is still open. [3]
The companies are engaging with regulatory authorities to seek approval for the mRNA vaccine. [3] Bancel said the company intends to 'go as fast as we can' in seeking FDA approval for intismeran. [2]
Sources
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