Ficerafusp alfa shows 31% three-year OS in HPV-negative HNSCC trial

Bicara's ficerafusp alfa plus pembrolizumab demonstrated approximately doubled overall survival compared to standard of care in first-line recurrent/metastatic HPV-negative head and neck cancer at three-year follow-up. The company is advancing the 1500mg weekly dose in its Phase 3 FORTIFI-HN01 pivotal study, with plans to initiate a new dosing regimen study in Q3 2026.