On February 19, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a global Phase 2 trial of zanubrutinib, an investigational inhibitor of Bruton’s tyrosine kinase (BTK), in patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL), which BeiGene refers to as the MAGNOLIA trial (Press release, BeiGene, FEB 19, 2019, View Source;p=RssLanding&cat=news&id=2388014 [SID1234533466]).
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Zanubrutinib was discovered by BeiGene scientists and is being developed globally as a monotherapy and in combination with other therapies to treat various hematologic malignancies. Zanubrutinib is being studied in several clinical trials as part of a broad development program and was granted Breakthrough Therapy designation for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and Fast Track designation for the treatment of patients with Waldenström macroglobulinemia (WM) by the U.S. Food and Drug Administration (FDA). BeiGene plans to submit an initial new drug application (NDA) to the FDA for zanubrutinib in 2019 or early 2020. In addition, BeiGene has submitted NDAs in China for R/R MCL and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), which have been accepted for review by the National Medical Products Administration (NMPA) and granted priority review.
"We are excited to initiate this Phase 2 trial following the preliminary results from our Phase 1 trial of zanubrutinib in patients with relapsed or refractory marginal zone lymphoma, in which seven objective responses in nine patients were reported. More than 1,300 patients worldwide have been treated with zanubrutinib, and we look forward to evaluating its potential in the MAGNOLIA trial for these patients who may find benefit with this novel BTK inhibitor," commented Jane Huang, M.D., Chief Medical Officer for Hematology at BeiGene.
The global, Phase 2, open-label, multi-center MAGNOLIA trial is expected to enroll approximately 65 patients with R/R MZL. The primary efficacy endpoint is overall response rate (ORR) determined by independent central review. Key secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), ORR by investigator assessment, and safety and tolerability.
For more information about the trial, patients and physicians should email BeiGene at [email protected].
About Marginal Zone Lymphoma
Marginal zone lymphoma is a group of indolent (slow growing) B-cell lymphomas that account for approximately 8% of all non-Hodgkin’s lymphoma (NHL) cases, according to the Lymphoma Research Foundation.1 The average age at diagnosis is 60 years, and it is slightly more common in women than in men.1 There are three types of MZL: extranodal marginal zone B-cell lymphoma or mucosa-associated lymphoid tissue (MALT), the most common type of MZL, which occurs outside the lymph nodes in places such as the stomach, small intestine, salivary gland, thyroid, eyes, and lungs; nodal marginal zone B-cell lymphoma, which occurs within the lymph nodes; and splenic marginal zone B-cell lymphoma, which occurs most often in the spleen and blood.
About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, currently the only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.
Zanubrutinib has been granted by the U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of patients with WM, and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy. The NDAs in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review.