other material
confidence high
sentiment positive
materiality 0.80
Bicycle Therapeutics reports positive Duravelo-2 mUC data with lower toxicity vs SOC
BICYCLE THERAPEUTICS PLC
- Zelenectide + pembrolizumab: 58% confirmed ORR (15/26) at optimal dose in first-line mUC; 62% with later response.
- Low adverse events: peripheral neuropathy 33%, skin reactions 17%, no Grade 4/5; only 1 discontinuation due to AE.
- Updated Duravelo-1: median PFS 13.0 months in cisplatin-ineligible patients on zelenectide + pembrolizumab.
- Further Phase 2 Duravelo-2 data from randomized trial expected in 2H 2026.