Clinical TrialMay 21, 2026, 05:11 PM
Bicara Ficerafusp Alfa Doubles 3-Year OS in HNSCC to 31%
AI Summary
Bicara Therapeutics announced positive three-year follow-up data from its Phase 1/1b study of ficerafusp alfa plus pembrolizumab in first-line recurrent/metastatic HPV-negative HNSCC. The 1500mg weekly dose demonstrated an estimated 31% overall survival at three years, approximately doubling the survival rate compared to standard of care. The data showed deep, durable responses driven by TGF-β inhibition and a well-tolerated safety profile, reinforcing its potential as a best-in-class therapy. The company is advancing to a Phase 3 study and plans a new dosing regimen study in Q3 2026.
Key Highlights
- Ficerafusp alfa + pembrolizumab showed an estimated 31% overall survival at 3 years for 1500mg QW dose.
- This OS rate approximately doubles that observed in retrospective analysis of standard of care pembrolizumab.
- Complete response rates matured to 13% (750mg QW), 25% (1500mg QW), and 30% (2000mg Q2W).
- Deep responses (≥80% tumor shrinkage) were achieved by 80% of responders in the 1500mg QW cohort.
- Pooled analysis showed deep responders had a median DOR of 31.6 months and median PFS of 36.9 months.
- Deep responders also showed a 63% reduction in the risk of death, with median OS not reached.
- Company plans to initiate a new 2250mg Q3W maintenance dose study in Q3 2026.
- Data will be presented at the 2026 ASCO Annual Meeting.
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