---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-125870"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2023-12-14T23:59:59+00:00"
generated_at: "2026-06-07T12:57:05.195372+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Bicycle Therapeutics reports 38% ORR for BT8009, 39% ORR for BT5528 in mUC; plans Phase 2/3 trial in Q1 2024

## Summary
- BT8009 showed 38% ORR in 26 EV-naïve mUC patients; median duration of response 11.1 months; zero severe peripheral neuropathy.
- BT7480 demonstrated two unconfirmed partial responses in cervical cancer and three prolonged stable disease (≥7 months).
- BT5528 achieved 39% ORR in 18 mUC patients; median DOR 4 months; no bleeding events observed.
- Plans to initiate Phase 2/3 Duravelo-2 registrational trial for BT8009 in mUC in Q1 2024.
- Next-generation Bicycle conjugates in development; BRC imaging data expected in 2024.

## SEC filing metadata
- accession: 0001104659-23-125870
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2023-12-14T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1761612/000110465923125870/0001104659-23-125870-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465923125870/tm2332810d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-125870
- JSON: https://secwatch.observer/filing/0001104659-23-125870.json
- Plain text: https://secwatch.observer/filing/0001104659-23-125870.txt

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