secwatch / observer

8-K filed May 21, 2026, 5:04 PM ET ticker BCAX CIK 0002023658

other material confidence high sentiment positive materiality 0.80

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.

item 8.01 item 9.01

Machine-readable event card

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
discovered_at: 2026-05-21T21:06:00.213115+00:00
generated_at: 2026-05-21T21:09:40.259380+00:00
sec_items: ["8.01", "9.01"]
event_type: other_material
sentiment: positive
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: high
secwatch_canonical_url: https://secwatch.observer/filing/0001628280-26-037377
json_url: https://secwatch.observer/filing/0001628280-26-037377.json
markdown_url: https://secwatch.observer/filing/0001628280-26-037377.md
text_url: https://secwatch.observer/filing/0001628280-26-037377.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/2023658/000162828026037377/0001628280-26-037377-index.htm
edgar_primary_document_url: https://www.sec.gov/Archives/edgar/data/2023658/000162828026037377/bcax-20260521.htm
generated_by_model: deepseek-v4-flash:cloud@v2
review_status: machine_generated
human_reviewed: false
corrected: false
correction_note: null
correction_timestamp: null
superseded_by: null

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