RE:RE:RE:RE:Moderna's CEO Stephan Bancel comments on mRNA cancer vaccineSeptember 12, 2024 - Last month Moderna was hoping for a quick green light for its personalised neoantigen immunotherapy mRNA-4157, but that hope evaporated on September 12th. The company disclosed during its R&D day that the FDA “has not been supportive” of accelerated approval in adjuvant melanoma based on current data on the Merck-partnered project – which includes a recent three-year update from its phase 2 trial, Keynote-942.
The FDA’s issue with mRNA-4157 is unclear but it’s possible that, with the melanoma sector already well served, the agency is waiting for a clear overall survival benefit.
This is in contrast to ONCY's pelareorep which has demonstrated statistically significant PFS and survival data in its Phase 2 Goblet-1 HR+/HER2- metastatic breast cancer clinical study, in a segment of breast cancer that remains an unmet treatment need, in which the FDA would grant an Accelerated Approval.