BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) a global biotechnology company, today announced that the results of the final progression free survival (PFS) analysis of the ALPINE trial will be presented at a late-breaking oral presentation session at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans.
ALPINE is a global Phase 3 trial comparing BRUKINSA (zanubrutinib) with IMBRUVICA (ibrutinib) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). The results will be presented at 10:15 am CST during the late-breaking abstract session on Tuesday, December 13, 2022 in the Ernest N. Morial Convention Center, Hall E.
In this final PFS analysis, BRUKINSA achieved superior PFS compared with ibrutinib, as assessed by both Independent Review Committee (IRC) and investigator (HR: 0.65 [95% CI, 0.49-0.86] p =.0024, for both investigator and IRC). The PFS results favored zanubrutinib consistently across major pre-defined subgroups including IGHV status and patients with del(17p)/TP53, regardless of IRC or investigator assessment.
BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy over ibrutinib in any treatment setting; The ALPINE trial results demonstrate superiority for both PFS and ORR versus ibrutinib in relapsed or refractory CLL/SLL,' said Mehrdad Mobasher, M.D., M.P.H. Chief Medical Officer, Hematology at BeiGene. 'With nearly 30 months of follow up in this trial, we have seen a very consistent safety and tolerability profile for BRUKINSA and look forward to sharing detailed results from this analysis at ASH.'
CLL is one of the most common types of leukemia, accounting for about one-quarter of new cases of leukemiai The condition is characterized by consecutive relapses, with response to therapy ultimately determining clinical benefit, including survival.
At this pre-defined response analysis with a median follow up of 29.6 months, BRUKINSA was generally well-tolerated with a safety profile consistent with previous reports. Overall discontinuation rates were lower with BRUKINSA (26.3%) compared to ibrutinib (41.2%), as well as discontinuations due to adverse events (16.2 vs 22.8%) or progressive disease (7.3 vs 12.9%).
Cardiac safety measures at this analysis favored BRUKINSA compared with ibrutinib: the rate of atrial fibrillation/flutter in the BRUKINSA arm remained low (5.2%) compared with ibrutinib (13.3%) and there were zero grade 5 adverse events due to cardiac disorders with BRUKINSA versus six in the ibrutinib arm.
Investor Events
Sunday, December 11, 2022 - BeiGene will host an ancillary event in New Orleans at 8:00 pm CST for investors and analysts attending ASH. BeiGene senior management will review highlights of the presented data, and special guests will join them for a Q&A panel.
Tuesday, December 13, 2022 - BeiGene will host a webcast following the ALPINE late-breaker presentation at 2:00 pm CST. BeiGene senior management along with invited medical experts will review the presented data and join for a Q&A panel.
Tuesday, December 13, 2022 - BeiGene will host a webcast in Chinese at 6:00 pm CST / December 14, 2022 8:00 am China time to capture Company presentations at ASH. BeiGene senior management will review highlights of the presented data.
These events can be accessed live from the investors section of BeiGene's website at http://ir.beigene.com, http://hkexir.beigene.com or https://sseir.beigene.com. Archived replays will be posted for 90 days following the events.
About BRUKINSA
BRUKINSA is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.
BRUKINSA is supported by a broad clinical program which includes more than 4,700 subjects in 35 trials in more than 30 countries and regions. To date, BRUKINSA is approved in 60 markets, including the United States, China, the European Union Great Britain, Canada, Australia, South Korea, Switzerland, and additional international markets.
About BeiGene
BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 9,000 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S. and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential for BRUKINSA to provide clinical benefit to patients with CLL, the future development, regulatory filing and approval, commercialization, and market access of BRUKINSA for CLL, the potential commercial opportunity for BRUKINSA, and BeiGene's plans, commitments, aspirations, and goals under the heading and 'About BeiGene.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, and other services; BeiGene's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability and the impact of the COVID-19 pandemic on BeiGene's clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled 'Risk Factors' in BeiGene's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.
Contact:
Kevin Mannix
Tel: +1 240-410-0129
Email: ir@beigene.com
BEIGENE, LTD. 
