BeiGene Announces First Presentation of the Phase 3 ALPINE Trial Comparing BRUKINSA (Zanubrutinib) to Ibrutinib in Chronic Lymphocytic Leukemia to Be Featured in Presidential Symposium at EHA2021

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that results from the interim analysis of the Phase 3 ALPINE trial comparing BRUKINSA (zanubrutinib) to ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will be reported in an oral presentation as part of the Presidential Symposium at the 26^th European Hematology Association 2021 (EHA2021) Virtual Congress. The abstract has also been selected by the Scientific Program Committee to be highlighted in the EHA2021 Virtual Press Briefing.

“The positive topline results from the Phase 3 ALPINE trial interim analysis suggest that BRUKINSA could improve clinical benefit for patients with CLL, compared to the first-generation BTK inhibitor,” said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. “BRUKINSA was designed to optimize selectivity and deliver sustained BTK inhibition, and we hope our bold approach in its clinical development, including two head-to-head trials, can provide additional evidence to support its potential as a best-in-class BTK inhibitor. We look forward to the first presentation of these data in the Presidential Symposium at EHA.”

Results from the interim analysis were based on 415 enrolled patients in the trial, including 207 on BRUKINSA treatment and 208 on ibrutinib treatment. As previously announced, the ALPINE trial met its primary endpoint, with BRUKINSA demonstrating non-inferiority in objective response rate (ORR) per investigator assessment and independent review committee (IRC), and superiority in ORR per investigator assessment. The trial also met a pre-specified secondary endpoint related to safety, with BRUKINSA demonstrating a statistically significant lower risk of atrial fibrillation or flutter, compared to ibrutinib.

More details on the ALPINE trial results will be provided by Peter Hillmen, MBChB, Ph.D., Professor of Experimental Haematology at University of Leeds and trial investigator, in an oral presentation (abstract code: LB1900) at EHA2021 on Friday, June 11 at 5:15 p.m. CEST (11:15 a.m. ET), as part of the Presidential Symposium.

BeiGene EHA2021 Investor Conference Call and Webcast Information

BeiGene will host an investor and analyst conference call and webcast to discuss results from the interim analysis of the ALPINE trial and other data presented at EHA2021 on Friday, June 11 at 12:00 p.m. (noon) ET.