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BeiGene Announces Acceptance and Priority Review by Health Canada of New Drug Submission for BRUKINSA® (zanubrutinib) in Waldenström’s Macroglobulinemia

CAMBRIDGE, Mass. & BEIJING–(BUSINESS WIRE)–BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that its New Drug Submission (NDS) for BRUKINSA® (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) has been accepted by Health Canada and granted priority review status.

“We believe that BRUKINSA’s safety advantages over ibrutinib as demonstrated in our head-to-head ASPEN trial, including reduced risk for certain cardiovascular issues, may help it become a preferred treatment option for patients with WM in Canada and around the world.”

“Following our recent submissions for WM in Europe and Australia, we are pleased to continue advancing the global registration of BRUKINSA with this new filing in Canada. BRUKINSA has approvals in the U.S. and China and is being developed with the goal of making it accessible to patients around the world who can benefit from it. For patients with WM, BRUKINSA has demonstrated efficacy and clinically meaningful improvements in safety and tolerability,” said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. “We believe that BRUKINSA’s safety advantages over ibrutinib as demonstrated in our head-to-head ASPEN trial, including reduced risk for certain cardiovascular issues, may help it become a preferred treatment option for patients with WM in Canada and around the world.”

Clinical data in the Canadian NDS include data from the Phase 3 randomized, open-label, multicenter ASPEN clinical trial (NCT03053440) that evaluated zanubrutinib versus ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM, which were presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program and the 25th European Hematology Association (EHA) Congress. In that study, zanubrutinib demonstrated more frequent VGPRs (28.4% vs.19.2% in overall population), although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met. Zanubrutinib also demonstrated advantages in safety and tolerability compared to ibrutinib. The safety package in the NDS includes pooled safety data from 779 patients with B-cell malignancies treated with BRUKINSA in six clinical trials.

About Waldenström’s Macroglobulinemia (WM)

WM is a rare lymphoma representing approximately 1% of all non-Hodgkin lymphomas and typically progresses slowly after diagnosis.i In Canada and the United States, the incidence rate of WM is about five cases per million people per year.ii

About the Zanubrutinib Clinical Trial Program

Clinical trials of zanubrutinib include:

  • Fully-enrolled Phase 3 ASPEN clinical trial in patients with Waldenström’s macroglobulinemia (WM) comparing zanubrutinib to ibrutinib (NCT03053440), currently the only approved BTK inhibitor for WM;
  • Phase 3 SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab in patients with treatment-naive (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (NCT03336333);
  • Phase 3 ALPINE trial comparing zanubrutinib to ibrutinib in patients with relapsed/refractory (R/R) CLL/SLL (NCT03734016);
  • Phase 3 MANGROVE trial comparing zanubrutinib and rituximab to bendamustine and rituximab in patients with untreated mantle cell lymphoma (MCL) (NCT04002297);
  • Phase 2 MAGNOLIA trial in patients with R/R marginal zone lymphoma (MZL) (NCT03846427);
  • Phase 2 ROSEWOOD trial (NCT03332017) in China comparing obinutuzumab and zanubrutinib vs obinutuzumab alone in treating patients with R/R FL;
  • Phase 2 trial (NCT04382586) in the U.S. comparing zanubrutinib plus supportive care to placebo plus supportive care for the treatment of patients with COVID-19 disease and pulmonary distress;
  • Phase 2 trial (NCT04116437) in the U.S. in patients with previously treated B-cell lymphoma intolerant of prior treatment with ibrutinib and/or acalabrutinib;
  • Phase 2 trial (NCT03332173) in China in patients with R/R WM; and
  • Completed Phase 2 trials in China in patients with R/R MCL (NCT03206970) and R/R CLL/SLL (NCT03206918).

About BRUKINSA® (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), discovered by BeiGene scientists, that is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

BRUKINSA was approved by the U.S. FDA in November 2019 to treat adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

BRUKINSA was approved in China in June 2020 for the treatment of MCL in adult patients who have received at least one prior therapy and the treatment of CLL/SLL in adult patients who have received at least one prior therapy.

BRUKINSA is not approved outside of the United States and China.

 

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