Bicycle Therapeutics aligns with FDA on Phase 2/3 registrational trial for BT8009 in metastatic bladder cancer

BICYCLE THERAPEUTICS PLC

FDA alignment reached on Duravelo-2 trial design; trial to begin Q1 2024.
Potential accelerated approval based on ORR, with PFS to confirm benefit.
Cohort 1: BT8009 + pembrolizumab in untreated metastatic bladder cancer.
Cohort 2: BT8009 monotherapy and combo in previously treated patients.
Discussions ongoing for confirmatory trial design in second-line-plus setting.

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