China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced plans to present the final progression-free survival (PFS) superiority analysis results of the Phase III ALPINE study for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) at the annual American Society of Hematology (ASH) meeting. The study assessed the efficacy of Brukinsa compared with Johnson & Johnson’s Imbruvica (ibrutinib) in patients with relapsed or refractory (r/r) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Study Results
In the final PFS analysis, Brukinsa achieved superior efficacy results compared with Imbruvica (HR: 0.65 [95% CI, 0.49-0.86], P=0.0024). This superiority was consistent across main predefined subgroups, including patients with different IGHV statuses and those with del (17p)/TP53 mutations. During the nearly 30-month follow-up period, Brukinsa demonstrated more stable safety and tolerance, with lower incidences of treatment discontinuation due to adverse events (16.2% vs. 22.8%) and disease progression (7.3% vs. 12.9%). Safety indicators related to cardiac function also favored Brukinsa, with a lower incidence of atrial fibrillation/atrial flutter (5.2% vs. 13.3%).
Drug Profile and Approvals
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 received approval in June 2020 for both MCL and CLL/SLL. The drug is currently undergoing 35 clinical studies in 28 markets globally, exploring its use in multiple B-cell malignancies 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 in China in 2017. It is currently approved for use in CLL/SLL, MCL, Waldenström’s macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic graft versus host disease (cGVHD).-Fineline Info & Tech
