BeiGene Initiates Pivotal Trial of PD-1 Antibody

BeiGene, Ltd. recently announced 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 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.

“It is estimated that the annual incidence of bladder cancer in China is between 55,000 and 80,000. 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, CEO, and Chairman.

“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,”added Amy Peterson, MD, 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.

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.

BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 400 employees in China, the US, and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, visit www.beigene.com.