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BeiGene initiates trial of PD-1 antibody BGB-A317 in China in patients with UC

Published 07/05/2017, 07:39 AM
© Reuters.  BeiGene initiates trial of PD-1 antibody BGB-A317 in China in patients with UC
BGNE
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  • BeiGene (NASDAQ:BGNE) announces that the first patient was dosed in a pivotal clinical trial in China of BGB-A317, an investigational anti-PD-1 antibody, in patients with urothelial cancer (UC), more commonly known as bladder cancer.
  • The Phase II single-arm, multi-center trial is designed to investigate the efficacy and safety of BGB-A317 in patients with previously treated, PD-L1-positive, locally advanced or metastatic UC.
  • The trial’s primary endpoint is the overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors Version 1.1, as assessed by independent review. Secondary endpoints include ORR as assessed by investigators, duration of response, disease control rate, progression-free survival, overall survival, safety, and tolerability.
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