BeiGene has started two new global pivotal clinical trials of its investigational candidate BGB-3111, a potent and selective small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK).

A new Phase II trial is designed to assess the combination of BGB-3111 and Gazyva (obinutuzumab) for the treatment of relapsed or refractory follicular lymphoma (FL).

In patients with treatment-naïve chronic lymphocytic leukaemia / small lymphocytic lymphoma (CLL/SLL), a new Phase III trial will compare BGB-3111 to bendamustine and rituximab (BR).

BeiGene founder, chairman and CEO John Oyler said: “The initiation of two additional pivotal trials expands our global registration-directed clinical development of BGB-3111 to additional indications, including patients with follicular lymphoma, a common B cell malignancy for which BTK inhibitors are not yet approved.

“We look forward to continuing the development of BGB-3111 as a potentially best-in-class BTK inhibitor for patients worldwide who suffer from haematological malignancies.”

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“We look forward to continuing the development of BGB-3111 as a potentially best-in-class BTK inhibitor for patients worldwide who suffer from haematological malignancies.”

Planned to enrol around 210 subjects in North America, Europe, Australia, and New Zealand, the Phase II trial will monitor overall response rate (ORR) as the primary endpoint.

The Phase III trial will measure progression-free survival (PFS) as the primary endpoint, with ORR, duration of response (DOR), overall survival (OS) and patient-reported outcomes being the secondary endpoints.

Being conducted in North America, Europe, Australia, New Zealand and Asia, the trial is set to recruit approximately 420 patients.

Additionally, BeiGene has announced the conclusion of enrolment in a separate Phase II trial of BGB-3111 being conducted in China for treating mantle cell lymphoma (MCL) patients.