Added support for use of Brukinsa in relapsed or refractory CLL/SLL

China-based biotech BeiGene (HKEX: 06160) has announced results from the Phase III ALPINE trial showing BTK inhibitor Brukinsa (zanubrutinib) demonstrated superiority versus ibrutinib in overall response rate (ORR) as assessed by an Independent Review Committee (IRC) in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

After achieving superiority in the primary endpoint of investigator-assessed overall response rate at the interim analysis, in this final response analysis, Brukinsa met the primary endpoint of superiority over ibrutinib in ORR as determined by IRC, with a response rate of 80.4% versus 72.9% (2-sided p=0.0264). ORR is defined as the combined rate of complete responses (CR) and partial responses (PR). A total of 652 patients were enrolled in the ALPINE trial across Europe (60%), the USA (17%), China (14%), New Zealand and Australia (9%) and were followed for a median of 24.2 months. The next planned analysis of ALPINE data will be the PFS final analysis.

Brukinsa was generally well tolerated with safety results consistent with previous studies. A prespecified safety analysis showed the rate of atrial fibrillation or flutter continued to be lower in the Brukinsa arm. The rate of atrial fibrillation or flutter at 24.2 months of median follow-up was 4.6% (n=15) in the Brukinsa arm and 12.0% (n=39) in the ibrutinib arm. Among 324 patients in each arm, 13.0% (n=42) of patients who received Brukinsa discontinued treatment due to adverse events compared to 17.6% (n=57) of patients who received ibrutinib. The most commonly reported grade 3 or higher adverse events for Brukinsa versus ibrutinib, respectively, were neutropenia (14.2% vs 13.9%), hypertension (12.7% vs 10.2%), pneumonia (4% vs 7.4%), neutrophil count decreased (4.3% vs 4.0%), COVID-19 pneumonia (4.3% vs 3.1%).