Merck and Moderna announced that their individualized neoantigen therapy, intismeran, met its primary endpoint in a Phase 3 melanoma trial. The combination of intismeran and Keytruda significantly improved recurrence-free survival compared to Keytruda alone.
Moderna (MRNA) shares soared over 100% in pre-market trading. Merck (MRK) shares rose approximately 9%.
This marks the first Phase 3 data for a personalized mRNA cancer vaccine custom-designed for individual tumor mutations. The results demonstrate the potential for mRNA technology to treat personalized cancers beyond infectious diseases.
The companies will present full trial data at an upcoming medical meeting. Discussions with regulatory authorities regarding approval submissions will begin shortly.