---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-128241"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2024-12-13T23:59:59+00:00"
generated_at: "2026-05-29T03:40:00.194586+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Bicycle Therapeutics Reports Positive Zelenectide Pevedotin Data in Multiple Cancers

## Summary
- Zelenectide pevedotin plus pembrolizumab showed 60% ORR in 22 first-line cisplatin-ineligible mUC patients.
- Breast cancer patients with NECTIN4 gene amplification had 62.5% ORR (5/8) vs. 14.3% in all evaluable patients.
- NSCLC patients with NECTIN4 gene amplification achieved 40.0% ORR (2/5); no responses in non-amplified patients.
- Company plans Phase 1/2 trials in NECTIN4-amplified breast, lung, and other cancers in 2025.
- Dose selection and topline data from Phase 2/3 Duravelo-2 trial expected in 2H 2025.

## SEC filing metadata
- accession: 0001104659-24-128241
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2024-12-13T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1761612/000110465924128241/0001104659-24-128241-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465924128241/tm2430827d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-128241
- JSON: https://secwatch.observer/filing/0001104659-24-128241.json
- Plain text: https://secwatch.observer/filing/0001104659-24-128241.txt

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