Results from a phase 1/1b study suggest that combining pembrolizumab (Keytruda) with ficerafusp alfa (BCA101) may improve outcomes for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), particularly those with HPV-negative disease. Ficerafusp alfa is a novel antibody designed to block both EGFR and TGF-β, two pathways linked to treatment resistance.
Among 28 evaluable patients with HPV-negative tumors, the combination achieved a 54% objective response rate, including a 21% complete response rate. Responses were often rapid and durable, with a median response duration of 21.7 months. Median progression-free survival was 9.9 months, and median overall survival reached 21.3 months.
In the smaller HPV-positive group, the response rate was 27%, with a median overall survival of 16.4 months.
The treatment showed a manageable safety profile. Common side effects included skin rash, fatigue, and itching. Severe treatment-related side effects occurred in 45% of patients, but no treatment-related deaths were reported.
Based on these encouraging results, a global phase 2/3 trial is now underway to compare the combination directly with pembrolizumab alone in patients with HPV-negative disease.