BeiGene Highlights Progress in Hematology at EHA2021 Virtual Congress - Seite 2

• ALPINE trial in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) – in the recently announced positive interim results, BRUKINSA demonstrated superiority in objective response rate (ORR) per investigator assessment and non-inferiority in ORR per both investigator assessment and independent review committee (IRC). Data pertaining to progression-free survival (PFS), a secondary endpoint of the trial, were immature at the data cutoff for the interim analysis; however, the descriptive summaries of PFS showed an early trend favoring BRUKINSA. In addition, BRUKINSA demonstrated a statistically significant lower risk of atrial fibrillation or flutter compared to ibrutinib, and the overall safety profile of BRUKINSA was consistent with the previously seen profile in its clinical development program; and
• ASPEN trial in Waldenström’s macroglobulinemia (WM) – in the results presented at last year’s ASCO and EHA meetings, BRUKINSA demonstrated clinically meaningful improvements in safety and tolerability, including a lower risk of atrial fibrillation or flutter, and a favorable combined complete and very good partial response rate compared to ibrutinib.

In addition to the head-to-head trials demonstrating BRUKINSA’s clinical profile compared to ibrutinib, BRUKINSA is being evaluated in an ongoing Phase 2 trial in patients with previously treated B-cell malignancies who were intolerant to ibrutinib and/or acalabrutinib. Results from this trial at a prior data cutoff were presented in a poster at the 62nd ASH Annual Meeting in December 2020, including that most intolerable adverse events patients experienced on other BTK inhibitors did not recur with BRUKINSA treatment, and that the vast majority of patients who were evaluable for response at the time of data cutoff maintained or improved their responses on BRUKINSA. Updated results from this trial will be presented at EHA2021.

In June 2020, BRUKINSA received its first approvals in China in both R/R CLL and R/R mantle cell lymphoma (MCL). Long-term follow-up data from the clinical trials supporting these two approvals will be presented at EHA2021. From results in the accepted abstracts, BRUKINSA demonstrated deep and durable responses across all subgroups in these trials, including high-risk patients, with a median follow-up over 33 months. No new safety signals were identified.