Bicara Therapeutics presented preliminary data from a Phase 1b expansion cohort evaluating 750 mg of ficerafusp alfa weekly in combination with pembrolizumab for head and neck squamous cell carcinoma (HNSCC).
Data showed consistent overall response rate and safety profile comparable to higher doses, indicating potential for deeper tumor responses and durable outcomes.
Higher dose of ficerafusp alfa demonstrated greater TGF-β inhibition and immune activation leading to more profound clinical responses.
Optimal Dose Declaration
Declaration of optimal dose for pivotal FORTIFI-HN01 study expected in Q1 2026.
Biological Dose Optimization
Plans to determine the optimal biologic dose for FORTIFI-HN01 trial in the first quarter of 2026.
Safety and Efficacy
750mg ficerafusp alfa in combination with pembrolizumab demonstrated a 57% confirmed overall response rate with 29% deep responses.
- The presentation marks an important advancement in dose optimization strategy for treating R/M HNSCC.
- Data suggests that increased TGF-β inhibition with higher doses drives more durable outcomes for patients.
- Bicara Therapeutics is on track to accelerate approval in the FORTIFI-HN01 pivotal trial based on promising interim response rates.
The findings from the Phase 1b expansion cohort underscore the potential of ficerafusp alfa in combination therapy for HNSCC, paving the way for further advancements in cancer treatment.