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.”
“This milestone underscores the potential for personalized approaches to help improve outcomes for people living with certain types of melanoma,” said Dr. Eric H. Rubin, senior vice president, global clinical development, Merck Research Laboratories. “We look forward to working with the EMA, in collaboration with Moderna, to advance our clinical development program for mRNA-4157/V940 in combination with KEYTRUDA.”
PRIME is a regulatory mechanism run by the EMA that provides support for the development of medicines that target an unmet medical need. Through PRIME, the EMA offers early and proactive support to help optimize the generation of robust data on a medicine’s benefits and risks and speed up the development and evaluation of medicines applications, with the objective of helping patients benefit as early as possible from therapies that may significantly improve their quality of life.
As previously announced, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for mRNA-4157/V940 in combination with KEYTRUDA for the adjuvant treatment of patients with stage III/IV high-risk melanoma following complete resection.
"The companies continue to discuss the results of the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial with regulatory authorities and plan to initiate a Phase 3 study in 2023 and rapidly expand to additional tumor types, including non-small cell lung cancer," the release stated.
