Bicara Therapeutics presents ficerafusp alfa Phase 1b data in HPV-negative head and neck cancer
BCAX•Ficerafusp alfa combined with pembrolizumab showed a 54% confirmed response rate and median overall survival of 21.3 months in Phase 1b testing. Bicara said its FORTIFI-HN01 trial is substantially enrolled and is targeting a mid-2027 interim analysis.
1. Phase 1b results
In Phase 1b testing, ficerafusp alfa at 1,500 mg weekly with pembrolizumab showed a 54% confirmed response rate, median overall survival of 21.3 months, median response duration of 21.7 months and median progression-free survival of 9.9 months. The combination showed no new safety signals, and no treatment-related deaths were reported.
2. Trial progress
Bicara Therapeutics said its FORTIFI-HN01 trial is substantially enrolled and is targeting a mid-2027 interim analysis that could support potential U.S. approval of ficerafusp alfa. The drug is being studied in first-line recurrent or metastatic HPV-negative head and neck cancer.
