If approved, BRUKINSA would be the only BTK
inhibitor for CLL in the European Union to achieve superior
efficacy versus standard of care in head-to-head trials
With significantly lower rates of atrial
fibrillation/flutter compared to standard of care, BRUKINSA has
potential to offer a more tolerable treatment option for certain
patients
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company focused on developing innovative and
affordable oncology medicines to improve treatment outcomes and
access for patients worldwide, today announced that the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has issued a positive opinion recommending
approval of BRUKINSA® (zanubrutinib) for the treatment of
adult patients with chronic lymphocytic leukemia (CLL).
“BRUKINSA was designed to overcome limitations in efficacy and
safety of first-generation Bruton’s Tyrosine Kinase inhibitors
(BTKi). As a result, BRUKINSA became the only BTKi to demonstrate
superiority versus ibrutinib in the largest head-to-head BTKi study
in relapsed/refractory (R/R) CLL, in addition to demonstrating
superior Progression-Free Survival (PFS) against bendamustine plus
rituximab (BR) in treatment-naïve (TN) patients regardless of age,
co-morbidities, mutation, or risk status,” said Mehrdad Mobasher,
M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “This
recommendation demonstrates the focus and urgency with which we are
delivering on our mission to accelerate development and broaden
access to innovative medicines around the globe.”
The CHMP recommendation is based on two global head-to-head
Phase 3 clinical trials in which BRUKINSA demonstrated superior
efficacy: ALPINE (NCT03734016) comparing BRUKINSA to ibrutinib in
patients with R/R CLL and SEQUOIA (NCT03336333) comparing BRUKINSA
to BR in patients with TN CLL. These two studies enrolled patients
from a total of 17 countries, including the United States, China,
Australia, New Zealand, and multiple countries in Europe.
Prof. Clemens Wendtner, Head of Hematology and Oncology at
Munich Clinic, an academic teaching hospital of the University of
Munich, Germany, commented, “BTK inhibitors have proven to be
highly effective oral treatments for CLL; however, the burden of
adverse events and discontinuations have a negative impact on
patients’ prognosis. The findings from two large head-to-head Phase
3 trials of BRUKINSA in CLL demonstrated efficacy across lines of
therapy in addition to consistently low rates of atrial
fibrillation/flutter and discontinuation across trials. These
clinical trial data suggest BRUKINSA has the potential to become a
practice-changing treatment option for CLL.”
“We are proud of the rapid progress we have made over the past
year bringing BRUKINSA to the blood cancer community in Europe,”
noted Gerwin Winter, Senior Vice President, Head of Europe at
BeiGene. “With this recommendation, we are looking forward to the
opportunity to provide this important medicine to more people with
hematologic malignancies in the European Union.”
Following the CHMP positive opinion, the European Commission
will consider BeiGene’s Marketing Application, with a final
decision expected within 67 days of receipt of the CHMP opinion.
The decision will be applicable to all 27 member states of the
European Union (EU), plus Iceland and Norway. 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 chemo-immunotherapy. Last
month, CHMP issued a positive opinion recommending approval of
BRUKINSA for the treatment of 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, Ireland, Italy, Spain, and Switzerland, 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.i,ii,iii CLL is one of the most common types of leukemia,
accounting for about one-quarter of new cases of leukemia.iv In
Europe, the estimated incidence is 4.92/100,000 persons per
year.v,vi
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 4,500 subjects in 35 trials across 28 markets. To date,
BRUKINSA has received approvals covering more than 55 countries and
regions, including the United States, China, the EU, Switzerland,
Great Britain, Canada, Australia, 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 3,300 colleagues dedicated to advancing more than 100
clinical trials that have involved more than 16,000 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 licensed medicines
discovered and developed in our own labs: BTK inhibitor BRUKINSA®
in the U.S., China, the European Union, Switzerland, Great Britain,
Canada, Australia, 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.
References
i 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 ii 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. iii
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
iv 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. v 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. vi 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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