BeiGene Announces Positive Topline Results from Phase 3 SEQUOIA Trial Comparing BRUKINSA (Zanubrutinib) to Bendamustine Plus Rituximab in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia - Seite 2

Cohort 2, representing high-risk patients treated with BRUKINSA monotherapy, was previously presented at the American Society for Hematology (ASH) Annual Meeting in December 2020. This cohort of patients with del(17p) achieved significant efficacy with an 18-month PFS of 90.6%, as assessed by investigator.

BeiGene plans to consult with global regulatory authorities on next steps and present these data at an upcoming major medical conference.

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults, with a global incidence of approximately 114,000 new cases in 2017.^1,2 CLL affects white blood cells or lymphocytes in the bone marrow.¹ Proliferation of cancer cells (leukemia) in the marrow result in reduced ability to fight infection and spread into the blood, which affects other parts of the body including the lymph nodes, liver and spleen.^1,3 The BTK pathway is a known route that signals malignant B cells and contributes to the onset of CLL.⁴ Small lymphocytic lymphoma (SLL) is a non-Hodgkin’s lymphoma affecting the B-lymphocytes of the immune system, which shares many similarities to CLL but with cancer cells found mostly in lymph nodes.⁵

About BRUKINSA

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 clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is approved in the following indications and regions:

• For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;
• For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;
• For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;
• For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021);
• For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021);
• Registered and reimbursed for the treatment of MCL in patients who have received at least one prior therapy (Israel, April 2021);
• For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)**; and
• For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021).

To date, more than 30 marketing authorization applications in multiple indications have been submitted covering the United States, the European Union, and more than 20 other countries or regions.