BRUKINSA is the only Bruton’s Tyrosine Kinase
(BTK) inhibitor to achieve superiority over IMBRUVICA®
(ibrutinib) in relapsed/refractory CLL.
BRUKINSA also showed superiority to
chemoimmunotherapy in treatment naive CLL.
BRUKINSA had a favorable safety profile,
including lower rates of atrial fibrillation/flutter compared with
IMBRUVICA.
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced that the European Commission
(EC) has approved BRUKINSA® (zanubrutinib) for the treatment
of adult patients with treatment-naïve (TN) or relapsed/refractory
(R/R) CLL.
“This approval represents an important milestone for CLL
patients and their physicians who now have a new chemotherapy-free
treatment option, and an alternative to current BTKi treatment
options,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical
Officer, Hematology at BeiGene. “Given that BRUKINSA has
demonstrated consistent benefit across patient subgroups,
regardless of risk status, we believe BRUKINSA could now be the
preferred treatment option for newly diagnosed and
relapsed/refractory CLL patients.”
The EC approval is based on positive results from two Phase 3
clinical trials: SEQUOIA (NCT03336333), in patients with previously
untreated CLL, and ALPINE (NCT03734016), in patients with R/R CLL.
In these two trials, BRUKINSA demonstrated superior efficacy versus
either bendamustine plus rituximab (B+R) or ibrutinib in first-line
or R/R CLL, respectively. BRUKINSA is the only BTKi to achieve
superiority versus ibrutinib in R/R CLL, as assessed by independent
review committee, with an overall response rate (ORR) of 80.4% vs
72.9% (p=0.0264).i Additionally, more BRUKINSA patients than
ibrutinib patients had a sustained response at 1 year with rates of
90% vs 78%.i The adverse events within the two trials were
consistent with the overall safety profile of BRUKINSA. Subsequent
to the regulatory submission, BeiGene announced topline results of
the final PFS analysis of the head-to-head ALPINE trial, in which
BRUKINSA demonstrated superior PFS compared with ibrutinib in
patients with R/R CLL.
Prof. Clemens Wendtner, Head of Hematology and Oncology at
Munich Clinic, an academic teaching hospital of the University of
Munich, Germany, commented, “BRUKINSA has demonstrated clinically
meaningful improvements as a next-generation BTKi over the first
generation BTKi, and is proven to be significantly more effective
and tolerable. Ensuring medicines are safe and tolerable for this
patient population is critical, given the long-term treatment
needed for CLL. Combined with the flexible dosing options, this
approval offers a practice-changing option for patients with CLL,
one of the most common types of leukemia in adults.”
“We’re pleased with the significant progress we’ve made to date
bringing BRUKINSA to patients with hematological malignancies
globally,” noted Gerwin Winter, Senior Vice President, Head of
Europe at BeiGene. “With this notable approval, we welcome the
opportunity to expand BeiGene’s presence in Europe and provide this
innovative treatment option to CLL patients across the region.”
BRUKINSA is currently approved in the EU for the treatment of
adult patients with WM who have received at least one prior therapy
or as the first-line treatment for patients unsuitable for
chemoimmunotherapy and adult patients with MZL who have received at
least one prior anti-CD20-based therapy.
In Europe, BeiGene has now obtained reimbursement for BRUKINSA
for the treatment of WM in Austria, Belgium, Denmark, England and
Wales, Germany, Iceland, Ireland, Italy, Luxembourg, Scotland,
Spain, Switzerland, and The Netherlands, while additional EU
countries are currently going through the reimbursement
process.
About Chronic Lymphocytic Leukemia (CLL)
A slow-growing, life-threatening and incurable cancer of adults,
CLL is a type of mature B-cell malignancy in which abnormal
leukemic B lymphocytes (a type of white blood cells) arise from the
bone marrow and flood peripheral blood, bone marrow, and lymphoid
tissues.ii-iv CLL is one of the most common types of leukemia,
accounting for about one-quarter of new cases of leukemia.v In
Europe, the estimated incidence is 4.92/100,000 persons per
year.vi,vii
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 25 countries and
regions. To date, BRUKINSA is approved in 58 markets, including the
United States, China, the European Union Great Britain, Canada,
Australia, South Korea, Switzerland, and additional international
markets.
BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class
clinical candidates internally or with like-minded partners to
develop impactful and affordable medicines for patients across the
globe. We have a growing R&D and medical affairs team of
approximately 3,500 colleagues dedicated to advancing more than 100
clinical trials that have involved more than 20,000 subjects. Our
expansive portfolio is directed predominantly by our internal
colleagues supporting clinical trials in more than 45 countries and
regions. Hematology-oncology, and solid tumor targeted therapies,
and immuno-oncology are key focus areas for the Company, with both
monotherapies and combination therapies prioritized in our research
and development. BeiGene currently has three approved medicines
discovered and developed in our own labs: BTK inhibitor BRUKINSA®
in the U.S., China, the European Union, Great Britain, Canada,
Australia, South Korea, Switzerland, and additional international
markets; and the non-FC-gamma receptor binding anti-PD-1 antibody
tislelizumab as well as the poly adenosine diphosphate-ribose
polymerase (PARP) inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialize a range of oncology medicines in China licensed from
Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also
plan to address greater areas of unmet need globally through our
other collaborations including Mirati Therapeutics, Seagen, and
Zymeworks.
In January 2021 BeiGene and Novartis announced a collaboration
granting Novartis rights to co-develop, manufacture, and
commercialize BeiGene’s anti-PD-1 antibody tislelizumab in North
America, Europe, and Japan. Building upon this productive
collaboration, BeiGene and Novartis announced an option,
collaboration, and license agreement in December 2021 for BeiGene’s
TIGIT inhibitor ociperlimab that is in Phase 3 development.
Novartis and BeiGene also entered into a strategic commercial
agreement through which BeiGene will promote five approved Novartis
oncology products across designated regions of China.
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 in the European
Union and other markets, the potential commercial opportunity for
BRUKINSA, and BeiGene’s 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 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.
IMBRUVICA® is a registered trademark of Pharmacyclics LLC and
Janssen Biotech, Inc.
References
i BRUKINSA® (zanubrutinib). Summary of product characteristics;
2022. ii National Cancer Institute. Surveillance, Epidemiology, and
End Results Program. Cancer Stat Facts: Leukemia —Chronic
Lymphocytic Leukemia (CLL). Accessed October 4,2021.
https://seer.cancer.gov/statfacts/html/clyl.html iii Aster JC,
Freedman A. Non-Hodgkin lymphomas and chronic lymphocytic
leukemias. In: Aster JC, Bunn HF (eds.). Pathophysiology of Blood
Disorders. 2nd ed. McGraw-Hill Education; 2017:chap 22. iv American
Cancer Society. What is chronic lymphocytic leukemia? Updated May
10, 2018. Accessed December 6, 2020.
https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html
v Yao Y, Lin X, Li F, Jin J, Wang H. The global burden and
attributable risk factors of chronic lymphocytic leukemia in 204
countries and territories from 1990 to 2019: analysis based on the
global burden of disease study 2019. Biomed Eng Online. 2022 Jan
11;21(1):4. doi: 10.1186/s12938-021-00973-6. PMID: 35016695; PMCID:
PMC8753864. vi Miranda-Filho, A., et al., Epidemiological patterns
of leukaemia in 184 countries: a population-based study. The Lancet
Haematology, 2018. 5(1): p. e14-e24. vii Sant, M., et al.,
Incidence of hematologic malignancies in Europe by morphologic
subtype: results of the HAEMACARE project. Blood, 2010. 116(19): p.
3724-34.
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Investor Contact Kevin Mannix +1 240-410-0129 ir@beigene.com
Media Contact Maryline Iva +41 616 852 090 media@beigene.com
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