BeiGene has begun dosing in a Phase II clinical trial of its investigational drug candidate BGB-3111 for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in China.
BGB-3111 is a potent and highly selective, investigational, small-molecule BTK inhibitor.
The single-arm, open-label, multi-centre Phase II trial will evaluate the efficacy and safety of BGB-3111 in patients with relapsed or refractory CLL / SLL.
BeiGene chairman and chief executive officer John Oyler said: “We are pleased to announce the start of the second pivotal clinical trial of BGB-3111 in China.
"With this trial, we hope to demonstrate BGB-3111’s efficacy and safety in Chinese patients with CLL / SLL and build upon the promising data we presented at last year’s ASH annual meeting from the global Phase I trial of BGB-3111 in patients with CLL / SLL."
The primary endpoint of the trial is the objective response rate, defined as achievement of either a partial response or complete response at any time on study drug.
The trial will also demonstrate secondary endpoints such as progression-free survival, duration of response, time to response, safety and tolerability.
BGB-3111 is being further studied in a Phase II trial in Chinese patients with relapsed or refractory mantle cell lymphoma (MCL) and a global Phase III clinical trial to treat patients with Waldenström’s Macroglobulinemia compared to ibrutinib.
With operations in China, the US, Australia and Taiwan, BeiGene primarily develops molecularly targeted and immuno-oncology cancer therapeutics.
Image: Small Lymphocytic Lymphoma. Photo: courtesy of Ed Uthman/Wikipedia.