BeiGene, Ltd., a biopharmaceutical company, has announced the commencement of a global Phase 2 trial for zanubrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, targeting patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL). This trial, referred to as the MAGNOLIA trial, follows promising preliminary results from a Phase 1 trial, where seven out of nine patients showed objective responses.
Zanubrutinib, discovered by BeiGene scientists, is part of a broad development program evaluating its use both as a monotherapy and in combination with other therapies for various hematologic malignancies. The drug has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA) for specific conditions, including mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM).
The MAGNOLIA trial is an open-label, multi-center study expected to enroll around 65 patients globally. The primary endpoint is the overall response rate (ORR), with secondary endpoints including progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety and tolerability.
Marginal zone lymphoma, a group of indolent B-cell lymphomas, represents about 8% of all non-Hodgkin’s lymphoma cases. It is slightly more prevalent in women and typically diagnosed around the age of 60. The disease manifests in three forms: extranodal marginal zone B-cell lymphoma, nodal marginal zone B-cell lymphoma, and splenic marginal zone B-cell lymphoma.
BeiGene is also advancing zanubrutinib through several other clinical trials globally, including a Phase 3 trial in WM comparing it to ibrutinib, and pivotal Phase 2 trials in China for MCL and CLL/SLL. The company plans to submit a new drug application (NDA) for zanubrutinib to the FDA in 2019 or early 2020, following the acceptance of NDAs in China for R/R MCL and R/R CLL/SLL by the National Medical Products Administration (NMPA).
For more information on the MAGNOLIA trial, patients and physicians are encouraged to contact BeiGene at clinicaltrials@beigene.com.
