Moderna's mRNA Cancer Vaccine Hits Phase III Win
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- Moderna announced on 19 August that its personalised mRNA cancer vaccine intismeran autogene, combined with pembrolizumab, produced statistically significant and clinically meaningful survival improvements in a phase III trial of 1,137 people who had surgery to remove melanomas
- An earlier trial of 157 melanoma patients over five years showed the vaccine-plus-pembrolizumab combination cut cancer recurrence risk by 50% and metastasis risk by 60% compared with pembrolizumab alone
- The vaccine is built by sequencing a patient's tumour biopsy, comparing it to healthy blood cells, and selecting up to 34 mutated surface proteins to encode in mRNA, which is injected into muscle like a COVID-19 shot
- BioNTech is also testing personalised mRNA cancer vaccines in human trials, and Moderna has trials underway for lung, kidney, and bladder cancers
- Pembrolizumab (Keytruda) is an anti-PD-1 antibody that blocks cancer cells' "don't attack me" signal, making it complementary to a vaccine that primes the immune system to attack
- Analysts told the Financial Times the treatment could be approved next year, though a January Reuters report estimated it would cost around $200,000 per treatment, and Moderna's share price is already soaring
Why it matters: If approved, this would be the first personalised mRNA cancer vaccine to clear a phase III trial, potentially opening a new treatment class for solid tumours beyond melanoma. The catch is scale: each dose is individually sequenced and manufactured, with Reuters estimating $200,000 per treatment — a pricing model that could constrain access even if regulators greenlight it next year.
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