Overview
- Moderna and Merck released detailed INTerpath-001 two-year results on Thursday showing intismeran plus Keytruda reduced the risk of melanoma recurrence or death by 42% versus Keytruda alone.
- The study also met its key secondary endpoint, with a 38% lower risk of distant metastasis or death and two-year recurrence-free rates of about 82% for the vaccine group and 70% for placebo.
- Overall survival data are not yet mature and the companies said they will continue follow-up and engage regulators to define approval pathways and required evidence.
- The trial recorded high rates of treatment-related side effects and raises questions about manufacturing time, scale, and cost for a vaccine made separately for each patient.
- The results were publicized early after a data leak that prompted a full release and a sharp sell-off in Moderna stock, and the NIH said it will pursue a national public–private effort to accelerate personalized cancer-vaccine research.