Bicara reports 31% 3-year OS with ficerafusp alfa + pembro in 1L R/M HPV-negative HNSCC

Bicara Therapeutics Inc.

Ficerafusp alfa 1500mg QW + pembrolizumab showed estimated 31% OS at 3 years, ~double retrospective standard of care OS (Vasiliadou et al. 2024).
CR rates matured to 13%, 25%, 30% across 750mg QW, 1500mg QW, 2000mg Q2W cohorts; deep responses (≥80% shrinkage) in 80% and 77% at higher doses.
Pooled analysis: deep responders had median DOR 31.6 months, median PFS 36.9 months (65% risk reduction), median OS not reached (63% risk reduction).
Company plans to initiate a loading-dose regimen study (2250mg Q3W) in Q3 2026 to support long-term administration.
Phase 3 FORTIFI-HN01 pivotal study ongoing; data presented at ASCO 2026.

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