The essentials
A personalized mRNA melanoma vaccine cut recurrence risk by 42% at two years, and regulatory discussions are ongoing.
Moderna and Merck have released full results from a late-stage trial of intismeran, a personalized mRNA cancer vaccine tested in melanoma. The trial enrolled more than 1,100 patients with surgically removed high-risk melanoma. Intismeran is a custom vaccine that targets neoantigens unique to each patient's tumor and uses the mRNA technology behind COVID-19 vaccines.
At two years after surgery, 82% of patients receiving intismeran plus Keytruda remained recurrence-free, compared with 70% of those receiving Keytruda alone, a 42% reduction in recurrence risk. The results reflect a two-year follow-up point. Reported side effects were mainly sore arm and fatigue.
The companies announced in August that the trial was successful. Full results were released early after partial data was leaked, ahead of an oncology meeting in Madrid. Moderna shares fell 18% following the release. The companies are in discussions with regulators on next steps toward approval. Production of each custom dose takes about six weeks, from tumor analysis to finished vaccine.
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Vaccine Group Shows 82% Recurrence-Free Rate Versus 70% at Two Years
Trial data show a higher share of patients remaining recurrence-free at two years in the vaccine-plus-Keytruda group, 82% compared with 70% for Keytruda alone. The approach is individualized, since each vaccine targets neoantigens specific to a patient's tumor. Reported side effects were mainly sore arm and fatigue, and discussions with regulators on next steps are underway.
Moderna Shares Fall 18% as Full Study Results Are Released
The share decline followed the release of full results after partial data had been leaked, ahead of a Madrid oncology meeting. The companies remain in discussions with regulators on next steps toward approval. Moderna's Massachusetts facility supplies doses for thousands of patients in international studies, showing the production scale behind the program.