Keytruda in head and neck cancer (KEYNOTE-040, 2016)
Merck tested pembrolizumab (Keytruda) against standard chemotherapy in recurrent or metastatic head and neck cancer. The trial missed its progression-free survival endpoint but showed an overall survival benefit.
Keytruda won approval for this indication based on the OS benefit.
The drug became a standard first-line treatment for head and neck cancer, and the precedent showed that missing PFS does not doom a cancer drug.
BioNTech is hoping BNT113 follows the same pattern: miss PFS but succeed on OS.
