Brukinsa demonstrates superior overall response rate versus ibrutinib in final response analysis of ALPINE trial.

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 United States (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%).

BeiGene has submitted results from the ALPINE trial in support of marketing authorization applications for Brukinsa in CLL in the U.S., EU and other markets around the world. In February 2022, BeiGene announced that the FDA and European Medicines Agency (EMA) have accepted supplemental new drug applications for Brukinsa in CLL. In the U.S., the Prescription Drug User Fee Act (PDUFA) target action date is October 22, 2022.

Interim results from the ALPINE trial representing a 12-month study follow-up were presented at the 26th European Hematology Association 2021 (EHA2021) Virtual Congress in June 2021 and showed Brukinsa demonstrated superiority in ORR versus ibrutinib, per investigator assessment.