Moderna mRNA cancer vaccine hits phase III milestone
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- Moderna announced on 19 August that its personalized mRNA cancer vaccine intismeran autogene, combined with pembrolizumab (Keytruda), produced statistically significant and clinically meaningful improvements in recurrence-free survival for 1,137 post-surgery melanoma patients in a phase III trial.
- An earlier 157-person, five-year trial showed the vaccine-pembrolizumab combination cut recurrence risk by 50% and risk of cancer spreading by 60% compared with pembrolizumab alone.
- The vaccine is made by sequencing a patient's tumor biopsy, comparing it against healthy blood cells to identify up to 34 distinctive surface-protein mutations, then manufacturing mRNAs that code for those proteins.
- Trials are already underway for lung, kidney, and bladder cancers, and BioNTech is also running human trials of personalized cancer vaccines.
- Analysts speaking to the Financial Times said the treatment could be approved next year, though a January Reuters report estimated each course could cost around $200,000 — a figure analysts link to Moderna's soaring share price.
- A study last year estimated that, if successful across cancer types, mRNA cancer vaccines could deliver health benefits worth around $75 billion a year in the US alone.
Why it matters: Moderna's share price has surged on the news and analysts project possible approval next year, meaning melanoma patients could become the first to access a truly individualized cancer therapy — but at an estimated $200,000 per patient, the economics will depend on whether health systems and insurers can absorb the cost of bespoke manufacturing at scale.
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