CAMBRIDGE, Mass. & BASEL, Switzerland & BEIJING–(BUSINESS WIRE)–BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company that develops and markets oncology medicines, today announced that the UK Institute for Health Technology Assessment, the National Institute for Health and Care Excellence (NICE), has published a Final Assessment Document (FAD) recommending BRUKINSA (zanubrutinib) for the treatment of Waldenström’s macroglobulinemia (WM) in adults who have received at least one treatment, only if bendamustine plus rituximab is also suitable.
This NICE decision makes BRUKINSA the first and only WM treatment to be recommended for routine use in England and Wales. The NICE Committee recognized the great unmet need for an effective and well-tolerated treatment for WM”where current chemoimmunotherapy options can cause serious adverse effects and the need for frequent hospital visits”.I
WM is a rare form of B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin’s lymphoma. There are around 4,000 people living with WM in the UK. ii
“BRUKINSA is a highly selective inhibitor of BTK,” said Dr Shirley D’Sa, Consultant Hematologist and Clinical Lead at University College London Hospitals Center for WM and Associated Disorders. “NICE’s positive recommendation for zanubrutinib gives eligible patients in England and Wales access to an important new treatment option that may offer better outcomes compared to the current standard of care.
In its review, NICE concluded that zanubrutinib could be considered “a step change” in disease management, as clinical evidence suggests that people with WM may live longer and have better health. life with zanubrutinib compared to standard care. The NICE recommendation states that BRUKINSA is considered cost-effective at a threshold of £20,000-30,000 per quality-adjusted life year (QALY).I
“I am very pleased that NICE has agreed that BRUKINSA is a valid treatment option for eligible WM patients in England and Wales, enabling these patients to be among the first patients in Europe to have access to BRUKINSA,” commented Dr Robert Mulrooney, BeiGene General Manager, UK and Ireland. “BeiGene’s mission is to provide affordable access to our innovative medicines and we look forward to working with NICE and the UK National Health Service to create new treatment options for UK patients with blood cancers.
About Waldenstrom’s Macroglobulinemia
WM is a rare B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin’s lymphoma.iii The disease usually affects older people and is mainly found in the bone marrow, although the lymph nodes and spleen may be involved.iv Typically, patients present between the ages of 60 and 70. For reasons that are unclear, WM is almost twice as common in men as in women and is more common in Caucasians than in other ethnic groups.v Waldenström’s macroglobulinemia is a rare cancer seen in about three to five people per million per year.iv
BRUKINSA (zanubrutinib) is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor discovered by BeiGene scientists that is currently being evaluated globally in an extensive clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Since novel BTK is continuously synthesized, BRUKINSA was specifically designed to provide targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life and selectivity. With differentiated pharmacokinetics compared to other licensed BTK inhibitors, BRUKINSA has been shown to inhibit malignant B cell proliferation in a number of disease-relevant tissues.
BeiGene is committed to advancing best-in-class and first-in-class clinical candidates internally or with like-minded partners to develop effective and affordable medicines for patients worldwide. We have a growing R&D and medical affairs team of approximately 3,300 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our broad portfolio is primarily driven by our internal colleagues who support clinical trials in over 45 countries and regions. Hematology-oncology and targeted therapies for solid tumors and immuno-oncology are key focus areas for the Company, with monotherapies and combination therapies being priorities in our research and development. BeiGene currently has three licensed drugs discovered and developed in our own laboratories: BTK inhibitor BRUKINSA® in the United States, China, European Union, Great Britain, Canada, Australia and other other international markets; and tislelizumab, an anti-PD-1 antibody that binds to the non-FC-gamma receptor, as well as pamiparib, a PARP inhibitor, in China.
BeiGene also partners with innovative companies that share our goal of developing therapies to meet global health needs. We market a range of oncology drugs in China under license from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address larger areas of unmet need globally through our other collaborations, including with Mirati Therapeutics, Seagen and Zymeworks.
In January 2021, BeiGene and Novartis announced a collaboration granting Novartis the rights to co-develop, manufacture and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe and Japan. Building on this productive collaboration, including a Biologics License Application (BLA) under review by the U.S. Food and Drug Administration (FDA), BeiGene and Novartis announced an option, collaboration and license in December 2021 for ociperlimab, a TIGIT inhibitor from BeiGene, which is in phase 3 development. Novartis and BeiGene have also entered into a strategic commercial agreement whereby BeiGene will promote five approved Novartis Oncology products in designated regions of China.
BeiGene is a global biotechnology company that develops and commercializes innovative and affordable oncology medicines to improve treatment outcomes and access to many more patients worldwide. With a broad portfolio, we are accelerating the development of our diverse pipeline of novel therapies through our in-house capabilities and collaborations. We are committed to radically improving access to medicines for many more patients who need them. Our growing global team of over 8,500 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, USA; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
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 of zanubrutinib to treat patients with WM, the advancement, the reimbursement and commercialization of zanubrutinib, and the plans, commitments, aspirations and goals under the headings “BeiGene Oncology” and “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements due to various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results of its drug candidates, which may not warrant 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 drugs and drug candidates, if approved; BeiGene’s ability to obtain and maintain intellectual property protection for its drugs 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 financing for operations and to complete the development and commercialization of its drug candidates and to achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, business, manufacturing and other operations, as well as the risks discussed in more detail in the section titled “Risk Factors” in BeiGene’s most recent quarterly report. BeiGene on Form 10-Q as well as discussions of potential risks, uncertainties and other important factors in BeiGene’s subsequent filings with the United States Securities and Exchange Commission. All information contained in this press release speaks as of the date of this press release, and BeiGene assumes no obligation to update such information except as required by law.
I National Institute for Health and Care Excellence. Final Evaluation Document – Zanubrutinib for the Treatment of Waldenström’s Macroglobulinemia [ID1427]. September 2022
ii Waldenström’s Macroglobulinemia UK Charity. Available at https://wmuk.org.uk
iii Buske, C, et al. Treatment and outcome patterns in European patients with Waldenström’s macroglobulinemia: a large retrospective observational chart review. The Lancet Hematology 2018; 5: e0299-309.
iv Lymphoma Research Foundation. Get the facts: Waldenström’s macroglobulinemia. Accessed March 2022. Available at https://lymphoma.org/wp-content/uploads/2021/12/LRF-Waldenstrom-Macroglobulinemia_Factsheet.pdf