EMA Awards PRIME Scheme Designation to mRNA-4157/V940 Plus Pembrolizumab in High-risk Melanoma
Source: OncLive, March 2023
The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) scheme designation to the personalized cancer vaccine mRNA-4157/V940 and pembrolizumab (Keytruda) for use as adjuvant treatment in patients with high-risk, stage III or IV melanoma following complete resection.
PRIME supports the development of medicines that target an unmet medical need. Through this designation, the EMA offers early and proactive support to augment the generation of robust data on the risk and benefits of a therapeutic approach and speed up the development and evaluation of drug applications to help patient benefit from life-changing treatments as early as possible.
The regulatory decision is supported by findings from the phase 2b KEYNOTE-942 trial (NCT03897881), in which the combination resulted in a statistically significant and clinically meaningful 44% reduction in the risk of disease recurrence or death vs single-agent pembrolizumab in this population (HR, 0.56; 95% CI, 0.31-1.08; P = .0266).