BeiGene’s BTKi is approved in more than 65
markets globally
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, announced today that BRUKINSA
(zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi), has
been approved by Health Canada for the treatment of adult patients
with chronic lymphocytic leukemia (CLL).
“BRUKINSA now has four approved indications in Canada,
demonstrating our commitment to bring this innovative BTKi
treatment option to more patients across the world,” said Mehrdad
Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at
BeiGene. “Our bold development program for BRUKINSA in CLL provided
evidence for superior efficacy in the first-line and
relapsed/refractory treatment settings, positioning BRUKINSA to
become the BTKi of choice.”
Typically diagnosed among individuals in their early 70s, CLL is
a slow-growing, incurable blood cancer and is the most common
leukemia in adults.1
“Because CLL is a chronic disease with many patients often
living with multiple health conditions, access to effective
treatment options with safe and favorable tolerability profiles is
critical,” says Dr. Christine Chen, MMEd, MD, FRCPC, Clinician
Investigator, Princess Margaret Cancer Centre. “That is why the
approval of zanubrutinib is seen as a clinical home run - not only
did it demonstrate a significant clinical benefit in the first line
CLL setting but it delivered superior efficacy versus ibrutinib in
patients with relapsed or refractory disease and did so with less
toxicity. And because most CLL patients are ultimately treated on
and off for years, zanubrutinib may represent a safer and more
effective option for patients with CLL.”
The Health Canada approval of BRUKINSA for CLL is based on
positive efficacy results and a favorable safety profile from two
global Phase 3, randomized, open-label, multicenter clinical
trials: SEQUOIA (NCT03336333), comparing zanubrutinib against
bendamustine plus rituximab (BR) in patients with previously
untreated CLL, and ALPINE (NCT03734016), comparing zanubrutinib
against ibrutinib in patients with relapsed or refractory (R/R)
CLL.2
Considered the largest head-to-head study of BTK inhibitors in
R/R CLL, the final ALPINE trial data were presented in a
late-breaking session at the 64th American Society of Hematology
Annual Meeting in December 2022 and simultaneously reported in The
New England Journal of Medicine.3,4 SEQUOIA trial results were
published in The Lancet Oncology in August 2022.5
“CLL Canada applauds continued innovation when it comes to
addressing the needs of Canadians who live with CLL. The approval
of zanubrutinib represents a significant advance for patients who
can benefit from an additional treatment option,” says Raymond
Vles, Board Chair, CLL Canada. “More importantly, becoming informed
and connecting with the CLL patient community will enable people
with CLL to discuss with their doctor the treatment and dosing
options that will work best for them and their lifestyle.”
About CLL2 CLL is a type of blood cancer. Over 2,200
people in Canada are diagnosed with CLL each year. CLL is more
common in men and occurs mainly in people over 60, with the average
age of diagnosis in the early 70s.
About BRUKINSA (zanubrutinib) BRUKINSA is a
small-molecule inhibitor of Bruton’s tyrosine kinase 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 4,900 subjects in 35 trials across 29 markets. To date,
BRUKINSA is approved in more than 65 markets around the world,
including the United States, China, the European Union, Great
Britain, Canada, Australia, South Korea, and Switzerland.
About BeiGene BeiGene is a global biotechnology company
that is discovering and developing innovative oncology treatments
that are more affordable and accessible to cancer 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 9,400 colleagues spans five
continents, with administrative offices in Basel; Beijing; and
Cambridge, U.S. 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 and to
become the BTKi of choice; the potential for BRUKINSA to be a safer
and more effective treatment option for patients; the future
development, regulatory filing and approval, commercialization, and
market access of BRUKINSA; and BeiGene’s plans, commitments,
aspirations, and goals under the heading “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.
IMPORTANT U.S. SAFETY
INFORMATION Warnings and
Precautions
Hemorrhage
Fatal and serious hemorrhage has occurred in patients with
hematological malignancies treated with BRUKINSA monotherapy. Grade
3 or higher hemorrhage, including intracranial and gastrointestinal
hemorrhage, hematuria and hemothorax have been reported in 3.6% of
patients treated with BRUKINSA monotherapy in clinical trials, with
fatalities occurring in 0.3% of patients. Bleeding of any grade,
excluding purpura and petechiae, occurred in 30% of patients.
Bleeding has occurred in patients with and without concomitant
antiplatelet or anticoagulation therapy. Coadministration of
BRUKINSA with antiplatelet or anticoagulant medications may further
increase the risk of hemorrhage.
Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA
if intracranial hemorrhage of any grade occurs. Consider the
benefit-risk of withholding BRUKINSA for 3-7 days pre- and
post-surgery depending upon the type of surgery and the risk of
bleeding.
Infections
Fatal and serious infections (including bacterial, viral, or
fungal infections) and opportunistic infections have occurred in
patients with hematological malignancies treated with BRUKINSA
monotherapy. Grade 3 or higher infections occurred in 24% of
patients, most commonly pneumonia (11%), with fatal infections
occurring in 2.9% of patients. Infections due to hepatitis B virus
(HBV) reactivation have occurred.
Consider prophylaxis for herpes simplex virus, pneumocystis
jiroveci pneumonia, and other infections according to standard of
care in patients who are at increased risk for infections. Monitor
and evaluate patients for fever or other signs and symptoms of
infection and treat appropriately.
Cytopenias
Grade 3 or 4 cytopenias, including neutropenia (22%),
thrombocytopenia (8%) and anemia (7%) based on laboratory
measurements, developed in patients treated with BRUKINSA
monotherapy. Grade 4 neutropenia occurred in 11% of patients, and
Grade 4 thrombocytopenia occurred in 2.8% of patients.
Monitor complete blood counts regularly during treatment and
interrupt treatment, reduce the dose, or discontinue treatment as
warranted. Treat using growth factor or transfusions, as
needed.
Second Primary Malignancies
Second primary malignancies, including non-skin carcinoma, have
occurred in 13% of patients treated with BRUKINSA monotherapy. The
most frequent second primary malignancy was non-melanoma skin
cancer reported in 7% of patients. Other second primary
malignancies included malignant solid tumors (5%), melanoma (1.2%),
and hematologic malignancies (0.5%). Advise patients to use sun
protection and monitor patients for the development of second
primary malignancies.
Cardiac Arrhythmias
Serious cardiac arrhythmias have occurred in patients treated
with BRUKINSA. Atrial fibrillation and atrial flutter were reported
in 3.7% of 1550 patients treated with BRUKINSA monotherapy,
including Grade 3 or higher cases in 1.7% of patients. Patients
with cardiac risk factors, hypertension and acute infections may be
at increased risk. Grade 3 or higher ventricular arrhythmias were
reported in 0.2% of patients.
Monitor for signs and symptoms for cardiac arrhythmias (e.g.
palpitations, dizziness, syncope, dyspnea, chest discomfort),
manage appropriately, and consider the risks and benefits of
continued BRUKINSA treatment.
Embryo-Fetal Toxicity
Based on findings in animals, BRUKINSA can cause fetal harm when
administered to a pregnant woman. Administration of zanubrutinib to
pregnant rats during the period of organogenesis caused
embryo-fetal toxicity, including malformations at exposures that
were 5 times higher than those reported in patients at the
recommended dose of 160 mg twice daily. Advise women to avoid
becoming pregnant while taking BRUKINSA and for 1 week after the
last dose. Advise men to avoid fathering a child during treatment
and for 1 week after the last dose. If this drug is used during
pregnancy, or if the patient becomes pregnant while taking this
drug, the patient should be apprised of the potential hazard to a
fetus.
Adverse Reactions
The most common adverse reactions (≥30%), including laboratory
abnormalities, included decreased neutrophil count (42%), upper
respiratory tract infection (39%), decreased platelet count (34%),
hemorrhage (30%), and musculoskeletal pain (30%).
Drug Interactions
CYP3A Inhibitors: When BRUKINSA is co-administered with a
strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily.
For coadministration with a moderate CYP3A inhibitor, reduce
BRUKINSA dose to 80 mg twice daily.
CYP3A Inducers: Avoid coadministration with strong or
moderate CYP3A inducers. Dose adjustment may be recommended with
moderate CYP3A inducers.
Specific Populations
Lactation: Advise not to breastfeed.
Hepatic Impairment: The recommended dose of BRUKINSA for
patients with severe hepatic impairment is 80 mg orally twice
daily.
U.S. INDICATIONS
BRUKINSA is indicated for the treatment of adult patients
with:
- Waldenstr�m’s macroglobulinemia (WM).
- Mantle cell lymphoma (MCL) who have received at least one prior
therapy.
- Relapsed or refractory marginal zone lymphoma (MZL) who have
received at least one anti-CD20-based regimen.
- Chronic lymphocytic leukemia (CLL) or small lymphocytic
leukemia (SLL).
The MCL and MZL indications are approved under accelerated
approval based on overall response rate. Continued approval for
these indications may be contingent upon verification and
description of clinical benefit in confirmatory trials.
For more information on BRUKINSA in
Canada
Please consult the BRUKINSA Product Monograph. The Product
Monograph is also available by calling 1-877-828-5598.
References _____________________________________ 1Lymphoma
Canada www.lymphoma.ca/lymphoma/cll-sll/about-cll-sll/
2BRUKINSA (zanubrutinib) Canada Product Monograph. May 23, 2023.
Available at: https://pdf.hres.ca/dpd_pm/00070886.PDF 3 Brown JR,
Eichhorst, B, Hillmen, P., et al. (2022) Zanubrutinib or Ibrutinib
in Relapsed/Refractory Chronic Lymphocytic Leukemia. New England
Journal of Medicine. Doi:10.1056/NEJMoa2211582 4 Brown JR,
Eichhorst, B. Hillmen P, et al.; Zanubrutinib Demonstrates Superior
Progression-Free Survival (PFS) Compared with Ibrutinib for
Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia and
Small Lymphocytic Lymphoma (r/R CLL/SLL): Results from Final
Analysis of ALPINE Randomized Phase 3 Study. Blood.2022:
140(Supplement 2): LBA-6.doi.1182/blood-2022-171538. 5 Tam CS,
Brown JR, Kahl BS, et al. (2022). Zanubrutinib versus bendamustine
and rituximab in untreated chronic lymphocytic leukaemia and small
lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3
trial. The Lancet Oncology, 23(8), 1031-1043. DOI:
https://doi.org/10.1016/S1470-2045(22)00293-5.
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Investor Contact Kevin Mannix 1-240-410-0129
ir@beigene.com
Media Contact Kyle Blankenship 1-667-351-5176
media@beigene.com
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