The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to mRNA-4157/V940, a personalized mRNA cancer vaccine, in combination with pembrolizumab (Keytruda) as adjuvant treatment in patients with high-risk melanoma who have undergone complete resection.
The vaccine candidate is designed to generate specific T-cell responses based on the unique mutational signature of a patient’s tumor.
The breakthrough designation is supported by data from the phase 2 KEYNOTE-942 trial (ClinicalTrials.gov Identifier: NCT03897881), which was designed to compare mRNA-4157/V940 plus pembrolizumab to pembrolizumab alone in patients with stage III/IV melanoma who underwent complete resection (n=157).
The combination significantly reduced the risk of disease recurrence or death by 44% compared with pembrolizumab alone (hazard ratio, 0.56; 95% CI, 0.31-1.08; 1-sided P =.0266).
A phase 3 study in adjuvant melanoma is expected to begin this year. Moderna and Merck plan to expand the research into other tumor types as well, including non-small cell lung cancer.
Moderna and Merck announce mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda® (pembrolizumab), was granted Breakthrough Therapy designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection. News release. Moderna and Merck. February 22, 2023. Accessed February 23, 2023.
Moderna and Merck announce mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda® (pembrolizumab), met primary efficacy endpoint in phase 2b KEYNOTE-942 trial. News release. Moderna and Merck. December 13, 2022. Accessed February 23, 2023.
This article originally appeared on MPR