FDA Greenlights BTD of a Personalized mRNA Vaccine for High-Risk Melanoma
Source: Targeted Oncology, February 2023
Positive data from the phase 2b KEYNOTE-942 trial (NCT03897881) have led to the FDA to grant a breakthrough therapy designation to mRNA-4157/V940 in combination with pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk melanoma following complete resection, according to Moderna, Inc.
mRNA-4157/V940 is a novel investigational messenger ribonucleic acid (mRNA)-based personalized cancer vaccine made of a single synthetic mRNA coding for up to 34 neoantigens. The vaccine works by stimulating an immune response through generating specific T cell responses based on the unique mutational signature of a patient’s tumor.
Early clinical studies have shown that the combination of mRNA-4157/V940 with pembrolizumab may potentially produce an additive benefit and enhance T cell-mediated destruction of tumor cells.