FDA Grants Breakthrough Therapy Designation to mRNA-4157/V940 Plus Pembrolizumab in High-Risk Melanoma
Source: Oncology Live, February 2023
The FDA has granted a breakthrough therapy designation to the investigational personalized mRNA cancer vaccine mRNA-4157/V940 in combination with pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk melanoma following complete resection.
The designation was based on data from the phase 2b KEYNOTE-942 trial (NCT03897881). Findings showed that the combination reduced the risk of recurrence or death by 44% compared with pembrolizumab alone (HR, 0.56; 95% CI, 0.31-1.08; one-sided P = .0266), meeting the trial’s primary end point for recurrence-free survival (RFS).
“The FDA’s breakthrough designation for mRNA-4157/V940 in combination with [pembrolizumab] reflects the excitement that we have for the potential promise of individualized cancer treatments,” Stephen Hoge, MD, president of Moderna, stated in a news release.1 “mRNA-4157/V940 in combination with [pembrolizumab] provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and potentially represents a new frontier in treating melanoma and other cancers. We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as continuing discussions with health authorities. We are grateful to the FDA for this designation.”