By Fineline Cube China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) demonstrated superior progression-free survival (PFS) in the Phase III ALPINE study compared to Johnson & Johnson’s Imbruvica (ibrutinib). The 12-month PFS rate for Brukinsa was 94.9%, compared to 84% for Imbruvica. Additionally, Brukinsa was well tolerated, with safety consistent with previous reports. Previously, BeiGene reported a superior overall response rate (ORR) for Brukinsa over ibrutinib based on data from the same ALPINE study in April 2022.
Study Design and Results
The randomized, global Phase III ALPINE study assessed the effects of Brukinsa compared to ibrutinib in previously treated patients with relapsed or refractory (r/r) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). A total of 652 patients were enrolled in the study, with 60% from Europe, 17% from the United States, 14% from China, and 9% from New Zealand and Australia. Patients were randomly divided into two groups and treated with either Brukinsa (160mg, oral, twice daily) or ibrutinib (420mg, oral, once daily) until disease progression or unacceptable toxicity. The primary endpoint was the overall response rate (ORR), while key secondary endpoints included PFS and the incidence of atrial fibrillation or atrial flutter. Other secondary endpoints included duration of remission (DoR), overall survival (OS), and the incidence of adverse events.
Regulatory and Market Presence
Brukinsa was first approved in the United States in November 2019 for the treatment of mantle cell lymphoma (MCL) in previously treated adult patients. In China, Brukinsa was approved for both MCL and for previously treated adults with CLL or SLL in June 2020. The drug is currently undergoing 35 clinical studies in 28 markets globally, targeting multiple B-cell malignant tumors either as monotherapy or in combination with other therapies.
Competitive Landscape
Ibrutinib, an oral BTK inhibitor co-developed by Cilag GmbH International (a Janssen Pharmaceuticals subsidiary) and Pharmacyclics LLC (an AbbVie company), was first approved in the US in 2014 and gained market approval in China in 2017. The drug is currently available for use in CLL/SLL, MCL, Waldenström’s macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic graft versus host disease (cGVHD).
Future Outlook
The superior results from the Phase III ALPINE study underscore Brukinsa’s potential as a leading BTK inhibitor. BeiGene’s commitment to advancing innovative treatments for B-cell malignancies positions the company to further expand its market presence and improve patient outcomes.-Fineline Info & Tech