Bicara’s Ficerafusp Alfa and Pembrolizumab Achieve 31% Three-Year Survival, 30% CR
At three-year median follow-up, Bicara’s ficerafusp alfa 1500mg weekly plus pembrolizumab achieved an estimated 31% overall survival, roughly doubling rates versus retrospective standard-of-care data. Complete response rates matured to 25% at 1500mg QW and 30% at 2000mg Q2W, with deep responses (>80% shrinkage) in over 75% of patients.
1. Extended Three-Year Survival Data
At median follow-up of three years, the 1500mg weekly ficerafusp alfa plus pembrolizumab cohort showed an estimated 31% overall survival, approximately double that seen in retrospective standard-of-care analyses. All three dose cohorts exhibited durable long-term outcomes in overall survival, progression-free survival, and duration of response with no new safety signals.
2. Response Rates and Durability
Complete response rates continued to mature, reaching 13% at 750mg QW, 25% at 1500mg QW, and 30% at 2000mg Q2W. Deep responses of at least 80% tumor shrinkage were achieved by 47% to 80% of patients across dose cohorts, driving increased durability and translating into extended PFS and DOR.
3. Mechanism and Next Steps
Ficerafusp alfa employs EGFR targeting combined with TGF-β ligand trapping to enhance tumor penetration and immune activation, underpinning its differentiated efficacy. The company is advancing a Phase 3 pivotal FORTIFI-HN01 study at 1500mg QW and plans a 12-week loading dose plus 2250mg maintenance regimen study in Q3 2026, with a conference call scheduled for May 22.