A phase 1/1b clinical trial has shown promising results for ficerafusp alfa (BCA101) combined with pembrolizumab (Keytruda) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Ficerafusp alfa is a first-in-class antibody that blocks both EGFR and TGF-β, two pathways linked to treatment resistance.
The strongest benefit was seen in patients with HPV-negative tumors, a group that typically has poor outcomes. Among 28 evaluable HPV-negative patients, the combination achieved a 54% response rate, including complete responses in 21% of patients. Responses were often rapid, with more than half appearing by the first scan, and many patients experienced major tumor shrinkage. Median overall survival reached 21.3 months, while median progression-free survival was 9.9 months.
The treatment was generally manageable. Common side effects included skin rash, fatigue, and itching, while severe treatment-related side effects occurred in 45% of patients. No treatment-related deaths were reported.
These encouraging findings have led to the launch of the phase 2/3 FORTIFI-HN01 trial, which will compare the combination directly against pembrolizumab alone in patients with PD-L1–positive, HPV-negative head and neck cancer.