secwatch.observer — SEC 8-K summary
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Issuer:     BICYCLE THERAPEUTICS PLC (BCYC)
CIK:        0001761612
Form:       8-K
Filed at:   2024-12-13T23:59:59+00:00
Accession:  0001104659-24-128241
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud

Bicycle Therapeutics Reports Positive Zelenectide Pevedotin Data in Multiple Cancers
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1761612/000110465924128241/0001104659-24-128241-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1761612/000110465924128241/tm2430827d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-128241

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer