Clinical-stage biopharmaceutical firm BeiGene has begun dosing in its Phase II clinical trial of BGB-3111 for the treatment of patients with mantle-cell lymphoma (MCL) in China.
BGB-3111 is a potent and highly selective, investigational, small-molecule inhibitor of Bruton’s Tyrosine Kinase (BTK) and blocks the signalling responsible for growth inhibition and cell death in malignant B-cells.
It is being developed as a monotherapy, as well as in combination with other therapies to treat lymphomas.
The single-arm, open-label, multi-centre Phase II trial will evaluate the efficacy and safety of the drug in patients with relapsed or refractory MCL.
BeiGene founder, chief executive officer and chairman John Oyler said: “We are pleased to announce the beginning of the first pivotal clinical trial of BGB-3111 in China.
"BGB-3111 has been under clinical investigation since August 2014, and more than 300 patients with various B-cell malignancies have been treated with BGB-3111 in Australia, New Zealand, the US, Korea and China.”
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's secondary endpoints will measure progression free survival, duration of response, time to response, safety and tolerability.
BGB-3111 is also being studied in a global Phase III trial in comparison with ibrutinib for the treatment of Waldenström’s Macroglobulinemia patients.
Ibrutinib is the only BTK inhibitor currently approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
A Phase I study indicated a higher exposure of BGB-3111 against BTK than ibrutinib, along with sustained 24-hour occupancy in both the blood and the lymph node.
Image: Lymph node with mantle-cell lymphoma. Photo: courtesy of Gabriel Caponetti/Wikipedia.