China’s BeiGene says a Phase 2 clinical trial testing the company’s new PD-1 antibody, BGB-A317, in patients with relapsed or refractory classical Hodgkin lymphoma has dosed its first patient. Professor Jun Zhu of Peking University Cancer Hospital will lead the study.
“We are dedicated to developing BGB-A317 broadly in China, where no immune checkpoint inhibitors are currently approved despite the considerable unmet need in patients with the country’s most prevalent cancers,” BeiGene’s founder and CEO, John V. Oyler, said in a press release. He added that “we also plan to initiate studies to enable regulatory approval of BGB-A317 in multiple geographies outside of China.”
BGB-A317 is a monoclonal antibody that targets the PD-1 molecule, a cell surface receptor that prevents T-cells from recognizing and killing cancer cells. While other approved therapies like Opdivo (nivolumab) and Keytruda (pembrolizumab) also target this receptor, BGB-A317 has a unique binding signature, and shows high affinity and superior target specificity.
The newly started Phase 2 trial is a single-arm, multi-center study assessing the safety and efficacy of BGB-A317 in classical Hodgkin lymphoma patients who have failed to respond or whose illness has worsened following prior treatment regimens.
The trial’s primary objective is to determine the overall response rate, deemed as the proportion of patients who achieved either a partial or a complete response after treatment. Secondary measures include progression-free survival, time to response and duration of response, as well as safety and tolerability.
“BGB-A317 has been administered to over 400 patients globally, and we have presented clinical data at international conferences demonstrating that this agent is well-tolerated with anti-tumor activity observed in multiple tumor types,” said Dr. Jane E. Huang, BeiGene’s chief medical officer. “We are pursuing the approval of our PD-1 antibody for patients with relapsed or refractory Hodgkin lymphoma in China because of the urgent unmet medical need and significant activity observed with this class of agents in this setting.”
The company is currently developing BGB-A317 as a monotherapy and in combination with other therapies for various cancer types.
One of its Phase 1b trials is testing the safety and anti-tumor activity of BGB-A317 in combination with the company’s PARP inhibitor, BGB-290, in patients with advanced solid tumors (NCT02660034).
BeiGene announced April 21 it will release preliminary data from this trial at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, which takes place June 2-6 in Chicago. Dr. Michael Friedlander will present the poster, “A Phase 1b Study of the Anti-PD-1 Monoclonal Antibody BGB-A317 (A317) in Combination with the PARP Inhibitor BGB-290 (290) in Advanced Solid Tumors.”