Biopharmaceutical company BeiGene has begun dosing patients in its Phase II clinical trial of BGB-A317 in China for the treatment of classical Hodgkin lymphoma (cHL).
BGB-A317 is an investigational, humanised monoclonal antibody with high affinity and specificity to the PD-1 receptor, which is found to prevent the stimulation of T-cells.
The single-arm, multi-centre Phase II trial will evaluate the efficacy and safety of the product in patients with relapsed or refractory cHL.
BeiGene haematology chief medical officer Jane Huang said: “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-tumour activity observed in multiple tumour types.
"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 Phase II trial's primary endpoint is the overall response rate measured by the Lugano Classification, while secondary endpoints include safety, tolerability, progression-free survival, complete response rate, duration of response and time to response.
According to BeiGene's chairman and chief executive officer John Oyler, the firm intends to further initiate trials in other countries for obtaining their regulatory approval.
BeiGene is developing BGB-A317 as a monotherapy, as well as combination therapy to treat different cancer types.
With operations in mainland China, the US, Australia and Taiwan, BeiGene's portfolio includes oral small molecules and monoclonal antibodies for cancer treatment.
Image: Micrograph of Hodgkin lymphoma. Photo: courtesy of Nephron.