Bicara’s Ficerafusp Alfa 2000mg Q2W Yields 48% ORR and 26% CR in R/M HNSCC
Bicara’s Phase 1b data show ficerafusp alfa 2000mg Q2W plus pembrolizumab in first-line HPV-negative R/M HNSCC achieved 48% confirmed ORR, 26% complete response rate and 77% of responders with ≥80% tumor shrinkage. The company will develop a loading dose plus three-week maintenance regimen pending regulatory alignment.
1. Phase 1b Expansion Cohort Results
In a cohort of 27 first-line HPV-negative R/M HNSCC patients, ficerafusp alfa 2000mg administered every two weeks with pembrolizumab produced a confirmed ORR of 48%, including a 26% complete response rate. Among responders, 77% achieved at least 80% tumor shrinkage, with a median time to response of 1.6 months and a safety profile consistent with known effects of the combination.
2. Dosing Strategy and Next Steps
Bicara plans to pursue a loading dose followed by a three-week maintenance schedule for ficerafusp alfa, aiming for regulatory alignment to support potential U.S. approval. The company continues to enroll patients in the Phase 3 FORTIFI-HN01 trial evaluating 1500mg weekly dosing in combination with pembrolizumab to confirm efficacy and safety in first-line R/M HNSCC.