secwatch.observer — SEC 8-K summary
======================================

Issuer:     BICYCLE THERAPEUTICS PLC (BCYC)
CIK:        0001761612
Form:       8-K
Filed at:   2023-02-14T23:59:59+00:00
Accession:  0001104659-23-021008
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1761612/000110465923021008/0001104659-23-021008-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1761612/000110465923021008/tm236546d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-021008

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