mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, + Keytruda, receives PRIME Scheme designation from the EMA for adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection

Moderna, Inc , and Merck Inc., known as MSD outside of the United States and Canada, 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 IIb 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.”

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 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 II2b KEYNOTE-942/mRNA-4157-P201 trial with regulatory authorities and plan to initiate a Phase III study in 2023 and rapidly expand to additional tumor types, including non-small cell lung cancer.

Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor mutation signature. mRNA-4157/V940 is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumor. Keytruda is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Based on early clinical studies, combining mRNA-4157/V940 with Keytruda may potentially provide an additive benefit and enhance T cell-mediated destruction of tumor cells.

About KEYNOTE-942/mRNA-4157-P201 (NCT03897881) : KEYNOTE-942 is an ongoing randomized, open-label Phase IIb trial that enrolled 157 patients with stage III/IV melanoma. Following complete surgical resection, patients were randomized to receive mRNA-4157/V940 (nine total doses of mRNA-4157) and Keytruda (200 mg every three weeks up to 18 cycles [for approximately one year]) versus Keytruda alone for approximately one year until disease recurrence or unacceptable toxicity. The primary endpoint is recurrence-free survival, and secondary endpoints include distant metastasis-free survival and safety.Key eligibility criteria for the trial included: patients with resectable cutaneous melanoma at high risk of recurrence, patients with complete resection within 13 weeks prior to the first dose of Keytruda patients were disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases.