BeiGene has started dosing patients in a global Phase III clinical trial to evaluate zanubrutinib for the treatment of relapsed / refractory chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
Zanubrutinib (BGB-3111) is an investigational, oral, small-molecule Bruton’s tyrosine kinase inhibitor.
The new Phase III trial will compare twice daily 160mg zanubrutinib with once daily 420mg ibrutinib in around 400 patients with relapsed / refractory CLL or SLL.
Chinese biopharmaceutical company BeiGene is conducting the study at nearly 150 sites in the US, China, Europe, Australia and New Zealand.
The trial’s primary endpoint is overall response rate, while the key secondary endpoints include progression-free survival, safety, duration of response, patient-reported outcomes and overall survival.
BeiGene Hematology chief medical officer Jane Huang said: "We continue to be encouraged by data on zanubrutinib in various B-cell malignancies and are excited to further expand the development programme for zanubrutinib in CLL and SLL with this Phase III trial, which represents the second Phase III study directly comparing zanubrutinib to ibrutinib."
The drug candidate is currently undergoing assessment in multiple trials as a monotherapy and combination therapy for different B-cell malignancies.
A Phase III trial for Waldenström macroglobulinemia (WM) is comparing zanubrutinib to ibrutinib, while a separate Phase III trial is investigating the drug candidate in previously untreated CLL patients.
In addition, a pivotal Phase II trial is being performed in combination with gazyva (obinutuzumab) for relapsed / refractory follicular lymphoma, along with another Phase II trial in patients with WM.