Merck, Moderna get PRIME scheme designation from EMA for personalized mRNA cancer vaccine, KEYTRUDA combo for adjuvant treatment of High-risk Melanoma
Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells.;
Cambridge: Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck, known as MSD outside of the United States and Canada, have 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 (PRIME) scheme designation by the European Medicines Agency (EMA) 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 (AACR) 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.”
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