FDA Greenlights BTD of a mRNA Vaccine for High-Risk Melanoma
February 23, 2023 - Positive data from Merck (MSD) 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.
Data showed that there was a 44% reduction in risk recurrence or death (HR, 0.56; 95% CI, 0.31-1.08; one-sided P = .0266) among patients who received the mRNA vaccine plus pembrolizumab compared with pembrolizumab alone.
https://www.targetedonc.com/view/fda-greenlights-btd-of-a-personalized-mrna-vaccine-for-high-risk-melanoma