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

BICYCLE THERAPEUTICS PLC

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.

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