CHMP recommends approval of BRUKINSA for the
treatment of relapsed or refractory marginal zone lymphoma
If approved, BRUKINSA will be the first and
only approved Bruton’s Tyrosine Kinase (BTK) inhibitor for marginal
zone lymphoma in Europe
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 marginal zone lymphoma (MZL) who have received
at least one prior anti-CD20-based therapy.
“There are currently no BTK inhibitors approved for MZL in
Europe and with this positive opinion, we are one step closer to
bringing forward a chemotherapy-free treatment option for this rare
blood cancer. We look forward to a decision from the European
Commission in the coming months,” said Mehrdad Mobasher, M.D.,
M.P.H., Chief Medical Officer, Hematology at BeiGene. “We have
undertaken a broad development program to evaluate BRUKINSA as a
potential treatment for various B-cell malignancies in over 4,500
patients, which continues to generate evidence to support BRUKINSA
as an effective and well-tolerated treatment option for blood
cancer patients around the world.”
The CHMP recommendation is based on positive results from the
Phase 2, open-label, multicenter, single-arm MAGNOLIA trial
(NCT03846427) in 66 patients with relapsed or refractory (R/R) MZL
who received at least one anti-CD20-based regimen. In the study,
the overall response rate (ORR) was 68% (95% CI: 55.6, 79.1) with
26% of patients achieving complete response (CR) and 42% achieving
partial response (PR). The median time to response was 2.8 months
(range: 1.7 to 11.1 months) and ORRs for MZL subtypes extranodal,
nodal, splenic, and unknown were 64%, 76%, 67%, and 50%,
respectively.
BRUKINSA demonstrated favorable and well-defined tolerability
consistent with its known safety profile. The most common (≥30%)
adverse reactions, including laboratory abnormalities, in the
pooled safety population of 847 patients were decreased neutrophil
count, upper respiratory tract infection, decreased platelet count,
and hemorrhage. The observed cardiac safety profile was consistent
with previous BRUKINSA studies, with low rates of atrial
fibrillation (3%) and atrial flutter (0.4%). BRUKINSA was
well-tolerated, as demonstrated by low rates of discontinuation due
to adverse events (6%).
Pier Luigi Zinzani, MD., PhD., Full Professor of Haematology at
the Institute of Haematology “Seràgnoli”, University of Bologna,
Italy commented, “Marginal zone lymphoma encompasses a number of
subtypes. As a highly selective BTK inhibitor, the clinical trial
data for BRUKINSA showed deep and sustained overall responses
regardless of subtype, along with a well-established safety
profile. If approved, BRUKINSA has the potential to deliver
meaningful outcomes for MZL patients in Europe who otherwise have
no approved treatment options.”
“This opinion is an important milestone as we work to bring a
BTK inhibitor for the first time to European MZL patients,” notes
Gerwin Winter, Senior Vice President, Head of Europe at BeiGene.
“We look forward to combining our global scale and local expertise
to deliver innovative medicines to patients across Europe.”
Following the CHMP positive opinion, the European Commission
will consider BeiGene’s Marketing Application, with a final
decision expected within 67 days 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 Waldenstr�m’s
macroglobulinemia (WM) who have received at least one prior therapy
or for the first-line treatment of patients unsuitable for
chemo-immunotherapy.
BeiGene has obtained reimbursement for BRUKINSA for the
treatment of Waldenstr�m’s macroglobulinemia in Austria, Belgium,
Denmark, England and Wales, Germany, Ireland, Spain, and
Switzerland while additional EU countries are currently going
through the reimbursement process.
About Marginal Zone Lymphoma MZL is a group of
ultra-rare, slow growing B-cell malignancies that begin in the
marginal zones of lymph tissue.i Epidemiological data from Europe
is limited, but the incidence rate of MZL is estimated to range
between 20 and 30 per million per year.ii,iii,iv There are three
different subtypes of MZL: extranodal marginal zone B-cell
lymphoma, or mucosa-associated lymphoid tissue (MALT), which is
most common; nodal marginal zone B-cell lymphoma which develops in
the lymph nodes and is rare; and splenic marginal zone B-cell
lymphoma which develops in the spleen, bone marrow, or both, and is
the rarest form of the disease.v
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. Because new BTK is continuously
synthesized, 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 more than 20 approvals covering more than 50
countries and regions, including the United States, China, the EU,
Great Britain, Canada, Australia, and additional international
markets. Currently, more than 40 additional regulatory submissions
are in review around the world.
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 mono- 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, and additional international
markets; and the non-FC-gamma receptor binding anti-PD-1 antibody,
tislelizumab, as well as the 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 with 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-PD1 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 8,500 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 MZL, 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.
i Annals of Oncology, Marginal Zone Lymphomas: ESMO Clinical
Practice Guidelines for diagnosis, treatment and follow-up, January
6, 2020. ii Cerhan, J.R. and T.M. Habermann, Epidemiology of
Marginal Zone Lymphoma. Ann Lymphoma, 2021. iii Smith, A., et al.,
Lymphoma incidence, survival and prevalence 2004-2014: sub-type
analyses from the UK's Haematological Malignancy Research Network.
Br J Cancer, 2015. 112(9): p. 1575-84. iv Maynadie, M., et al.,
Splenic Marginal Zone Lymphoma: French Registries Population-Based
Treatment and Survival Analyses (2002-2014). Blood, 2020. 136. v
Leukemia & Lymphoma Society, Marginal Zone Lymphoma. Available
at: https://www.lls.org/research/marginal-zone-lymphoma-mzl.
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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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