On July 5, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported 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 (Press release, BeiGene, JUL 5, 2017, View Source [SID1234519762]). The trial will evaluate BGB-A317 in Chinese patients with previously treated, PD-L1-positive, locally advanced or metastatic UC. BGB-A317 is also being evaluated in a pivotal trial in China in patients with relapsed or refractory classical Hodgkin lymphoma. Schedule your 30 min Free 1stOncology Demo! "It is estimated that the annual incidence of bladder cancer in China is between 55,000 and 80,0001,2. Chemotherapy-refractory bladder cancer patients in China have very limited treatment options and poor outcomes. This patient population is just one example of the unmet need for innovative cancer therapies, including PD-1 inhibitors. For this reason, we are committed to developing BGB-A317 broadly and look forward to initiating additional registrational trials of this agent in China," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.
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"This trial will examine BGB-A317’s efficacy and safety in patients with PD-L1-expressing bladder cancer, who we believe may be more likely to benefit from a PD-1 inhibitor. We plan to expand the development program for BGB-A317 in China and other geographies, both as monotherapy and in combination," commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology.
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 (RECIST V1.1), 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. Professor Dingwei Ye of the Fudan University Shanghai Cancer Center is the lead principal investigator of the trial.
About BGB-A317
BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1, and we believe it is differentiated from the currently approved PD-1 antibodies, as the ability to bind to Fc gamma receptors has been specifically engineered out. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.