secwatch.observer — SEC 8-K summary
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Issuer:     Bicara Therapeutics Inc. (BCAX)
CIK:        0002023658
Form:       8-K
Filed at:   2026-05-21T21:04:36+00:00
Accession:  0001628280-26-037377
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2023658/000162828026037377/0001628280-26-037377-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2023658/000162828026037377/bcax-20260521.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-037377

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer