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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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."
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe 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.
