Moderna, Merck say mRNA cancer vaccine-KEYTRUDA combo granted PRIME designation

Moderna (MRNA) and Merck (MRK) announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, has been granted Priority Medicines scheme designation by the European Medicines Agency for the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection. The EMA granted PRIME scheme designation based on positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. The first detailed results of the trial will be presented at the American Association for Cancer Research in Orlando, FL, from April 14-19. "Prime scheme designation for mRNA-4157/V940 in combination with KEYTRUDA highlights the potential promise of individualized cancer treatments in a population with limited alternatives," said Stephen Hoge, M.D., Moderna’s President. "There is a high unmet need for therapies in melanoma, as it can be a life-threatening condition where available therapies may not be sufficiently effective in a significant proportion of patients."