---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-021008"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2023-02-14T23:59:59+00:00"
generated_at: "2026-06-19T14:14:49.314763+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Bicycle Therapeutics announces Phase I BT8009 results: 50% ORR in urothelial cancer, well tolerated

## Summary
- 50% overall response rate (ORR) and 75% clinical benefit rate in urothelial cancer at 5 mg/m2; one complete response.
- Median duration of response estimated ~14 months; two of four responders remain on therapy as of Jan 2023.
- Confirmed partial responses in NSCLC and breast cancer patients, both Nectin-4 positive.
- Well tolerated: low rates of skin rash, neuropathy, pneumonitis; no Grade 3+ related events at 5 mg/m2.
- BT8009 advancing into dose expansion (up to 66 patients) and combination trial with pembrolizumab planned.

## SEC filing metadata
- accession: 0001104659-23-021008
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2023-02-14T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1761612/000110465923021008/0001104659-23-021008-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465923021008/tm236546d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-021008
- JSON: https://secwatch.observer/filing/0001104659-23-021008.json
- Plain text: https://secwatch.observer/filing/0001104659-23-021008.txt

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