Global biotechnology company BeiGene has commenced dosing patients in a new Phase II trial of its investigational anti-PD-1 antibody, BGB-A317, in patients with urothelial cancer (UC), more commonly known as bladder cancer, in China.
The single-arm, multi-centre trial seeks 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 includes the overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST V1.1), as assessed by independent review.
Secondary endpoints of the study will feature ORR as assessed by investigators, duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability.
BeiGenefounder, CEO and chairman John Oyler said: “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.”
China’s Fudan University Shanghai Cancer Centre professor Dingwei Ye is the lead principal investigator of the new Phase II trial.
BeiGene Immuno-Oncology chief medical officer Amy Peterson said: “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 programme for BGB-A317 in China and other geographies, both as monotherapy and in combination.”
In addition, BGB-A317 is currently being evaluated in a trial in China in patients with relapsed or refractory classical Hodgkin lymphoma.