FDA grants breakthrough therapy designation for Moderna and Merck mRNA and Keytruda® combination vaccine

Merck (known as MSD outside of the United States and Canada) and Moderna announced a new investigational mRNA cancer vaccine mRNA-4157/V940 combined with Keytruda® (pembrolizumab) has been granted Breakthrough Therapy Designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection. The designation will result in expedition of the FDA’s the  review of the combination treatment. According to the release, the companies will initiate a Phase 3 study in adjuvant melanoma in 2023, and rapidly expand to additional tumor types (including non-small cell lung cancer). Merck and Moderna exercised the option to jointly develop the treatment in October 2022.