---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-101202"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2024-09-19T23:59:59+00:00"
generated_at: "2026-05-31T03:41:06.124269+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 positive ESMO 2024 data: 45% ORR for zelenectide pevedotin in mUC

## Summary
- Zelenectide pevedotin monotherapy in mUC: 45% ORR (38 evaluable patients), 11.1 months median duration of response.
- BT5528 in mUC: 45% ORR in 6.5 mg/m² Q2W expansion cohort; EphA2 expression correlates with response.
- Low treatment-related peripheral neuropathy: 28% with zelenectide, 19% with BT5528; no Grade ≥3 events.
- BT7480 in advanced solid tumors: favorable safety, 13 of 39 patients stable disease, 2 unconfirmed PRs in cervical cancer.
- Global Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC is enrolling.

## SEC filing metadata
- accession: 0001104659-24-101202
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2024-09-19T23:59:59+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/1761612/000110465924101202/0001104659-24-101202-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465924101202/tm2424162d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-101202
- JSON: https://secwatch.observer/filing/0001104659-24-101202.json
- Plain text: https://secwatch.observer/filing/0001104659-24-101202.txt

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