Moderna's mRNA Cancer Vaccine Scores First Phase III Win
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- Moderna announced on 19 August that its personalized mRNA cancer vaccine (intismeran autogene), combined with pembrolizumab, improved recurrence-free survival in post-surgery melanoma patients versus pembrolizumab alone — the first Phase III success for a personalized cancer vaccine.
- The Phase III trial enrolled 1,137 melanoma patients randomized to receive both the vaccine and pembrolizumab, or pembrolizumab alone.
- An earlier 157-person, five-year trial found the vaccine-pembrolizumab combo cut recurrence risk by 50% and metastasis risk by 60% versus pembrolizumab alone.
- Moderna has not yet disclosed full Phase III data, saying only that the results are "statistically significant and clinically meaningful."
- Trials are already underway for lung, kidney, and bladder cancers, and rival BioNTech is testing personalized cancer vaccines in humans.
- Analysts told the Financial Times the treatment could be approved next year, with Reuters reporting pricing near $200,000 per course — sending Moderna's shares higher.
Why it matters: Analysts told the Financial Times approval could come next year, but Reuters estimates the individualized treatment will cost around $200,000 per course, making manufacturing scale and insurance coverage the real barriers. A study cited estimates potential health benefits at $75 billion per year in the US alone, and Moderna's shares are already soaring on the news.
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