Bicara Therapeutics selected 1500 mg of ficerafusp alfa as the optimal dose for the treatment of 1L HPV-negative R/M HNSCC in Phase 3 FORTIFI-HN01 pivotal study.
Anticipates achieving substantial enrollment in FORTIFI-HN01 in 2026 to enable interim analysis in mid-2027.
Plans to read out data from multiple expansion cohorts in 2026 to further characterize ficerafusp alfa's profile.
Optimal Dose Selection
1500 mg of ficerafusp alfa chosen for Phase 3 of the FORTIFI-HN01 pivotal study.
Commercial Launch Preparation
Focus on successful commercial launch in HPV-negative HNSCC market with potential blockbuster status for ficerafusp alfa.
Strategic Development Plan
Substantial enrollment target by end of 2026 for interim analysis in mid-2027 for FORTIFI-HN01.
Biological Rationale
Ficerafusp alfa's bifunctional design aims to improve tumor accessibility and enhance immune activity in tumors.
- Ficerafusp alfa has the potential to address the unmet need in the growing HPV-negative R/M HNSCC market.
- Clinical data shows promising outcomes with significant improvement in overall survival and response duration compared to standard care and other EGFR-targeting agents.
Bicara Therapeutics is positioned for growth in 2026 driven by the progress of ficerafusp alfa and strategic commercial preparations.