BeiGene Announces Updated Results from Phase 1 Clinical Trial of Zanubrutinib in Patients with Waldenström’s Macroglobulinemia

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CAMBRIDGE, Mass. and BEIJING, China, Oct. 12, 2018 (GLOBE NEWSWIRE) -- 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 updated results from the Phase 1 clinical trial of its investigational BTK inhibitor zanubrutinib, in an oral presentation at the 10 International Workshop on Waldenström’s Macroglobulinemia (IWWM). The IWWM meeting is taking place in New York City from October 11-13, 2018.

“As we prepare our first U.S. New Drug Application (NDA) filing for zanubrutinib, which we expect to file in the first half of 2019 in patients with Waldenström’s Macroglobulinemia (WM), we are pleased to update data in patients with WM from the Phase 1 trial that will support our filing. With more than 70 patients with WM now treated, we continue to see a high rate of deep and durable responses across genotypes, including high rates of overall, major, and very good partial responses (VGPRs),” commented Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. “We believe that the maturing data across B-cell malignancies continue to support a multi-regional approval strategy for zanubrutinib, including the ongoing NDA review in China for zanubrutinib in patients with relapsed/refractory mantle cell lymphoma by The National Medical Products Administration. We are hopeful that zanubrutinib, if approved, will represent a valuable treatment option across the globe for patients with several forms of B-cell malignancy.”

A Phase 1 trial of zanubrutinib as a monotherapy in patients with different subtypes of B-cell malignancies, including WM, is being conducted in Australia, New Zealand, the United States, Italy, and South Korea. As of July 24, 2018, 77 patients with treatment-naïve or relapsed/refractory WM have been enrolled in the trial. Seventy-three patients were evaluable for efficacy in this analysis and the median follow-up time was 22.5 months (4.1-43.9). The median time to response (PR) was 85 days (55-749). At the time of the data cutoff, 62 patients remained on study treatment. Updated results included:

“We are encouraged that additional data on zanubrutinib in patients with WM confirms the initially reported experience, with consistent demonstration of robust activity and good tolerability. We are hopeful that zanubrutinib, if approved, could potentially provide an important new treatment option to patients with WM and other hematologic malignancies,” said Constantine Tam, M.D., Director of Hematology, St. Vincent’s Hospital and Consultant Hematologist, Peter MacCallum Cancer Center, in Australia.

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Globe Newswire: 11:00 GMT Friday 12th October 2018

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