BeiGene (BGNE) Phase 2 Clinical Trial of Zanubrutinib in Patients with COVID-19-Related Pulmonary Distress Did Not Meet Co-primary Efficacy Endpoints

April 8, 2021 7:03 AM EDT

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BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the Phase 2 trial evaluating BRUKINSA® (zanubrutinib) in patients hospitalized with respiratory symptoms of COVID-19, requiring supplemental oxygen without mechanical ventilation, did not meet the co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen as compared to placebo. There were no new or additional safety signals for zanubrutinib identified in the trial.

“I am proud of the work by our teams at BeiGene and our research partners to further the understanding of the potential for BTK-inhibition against COVID-19-related respiratory distress. While the outcome of this Phase 2 trial is disappointing, I am heartened by the speed at which we mobilized to launch a clinical trial to explore if zanubrutinib might be able to help in the global fight against COVID-19,” said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. “Our mission has been to explore ways we can help patients around the world, supported by scientific rigor and well-designed and executed trials like this.”

BeiGene expects to submit these data for scientific presentation or publication in the future.

About the BGB-3111-219 Trial of Zanubrutinib for Patients with COVID-19

BeiGene initiated patient enrollment in a Phase 2 trial in the U.S. evaluating zanubrutinib for the treatment of patients with COVID-19-related pulmonary distress (NCT04382586) in May 2020.

The trial enrolled 67 patients with COVID-19 disease who either required supplemental oxygen or mechanical ventilation. The trial was designed to assess quickly whether treatment with zanubrutinib could help hospitalized patients with COVID-19-related pulmonary distress. Non-mechanically ventilated patients were randomized to receive oral zanubrutinib at 320 mg once daily for 28 days plus supportive care, or placebo plus supportive care. An additional cohort of four patients on mechanical ventilation received zanubrutinib plus supportive care. The trial’s co-primary endpoints were respiratory failure-free survival rate at day 28 and reduction in days on oxygen in the randomized cohort.

About BRUKINSA® (zanubrutinib)

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), discovered by BeiGene scientists. It 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.

About BeiGene

BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 5,400+ employees around the world are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology medicines: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market additional oncology products in China licensed from Amgen Inc.; Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company; and EUSA Pharma; and have entered a collaboration with Novartis Pharma AG for Novartis to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan. To learn more about BeiGene, please visit and follow us on Twitter at @BeiGeneUSA.

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