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, today announced 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.
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.
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