22 February 2023 - Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial.
Moderna and Merck today announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda, Merck's anti-PD-1 therapy, has been granted breakthrough therapy designation by the US FDA for the adjuvant treatment of patients with high-risk melanoma following complete resection.