---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-037377"
form_type: "8-K"
ticker: "BCAX"
cik: "0002023658"
company_name: "Bicara Therapeutics Inc."
filed_at: "2026-05-21T21:04:36+00:00"
generated_at: "2026-05-21T21:09:40.259380+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001628280-26-037377
- form_type: 8-K
- ticker: BCAX
- cik: 0002023658
- company_name: Bicara Therapeutics Inc.
- filed_at: 2026-05-21T21:04:36+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2023658/000162828026037377/0001628280-26-037377-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2023658/000162828026037377/bcax-20260521.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-037377
- JSON: https://secwatch.observer/filing/0001628280-26-037377.json
- Plain text: https://secwatch.observer/filing/0001628280-26-037377.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.