Marks BRUKINSA’s second approved indication in
Australia, on the heels of its recent initial approval in
Waldenstr�m’s macroglobulinemia
To date, BRUKINSA is approved in mantle cell
lymphoma in nine countries
BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven
biotechnology company focused on developing innovative and
affordable medicines to improve treatment outcomes and access for
patients worldwide, today announced that BRUKINSA® (zanubrutinib)
has been approved in Australia for the treatment of adult patients
with mantle cell lymphoma (MCL) who have received at least one
prior therapy. On October 7, 2021, BRUKINSA received its initial
approval in Australia for the treatment of adult patients with
Waldenstr�m’s macroglobulinemia (WM) who have received at least one
prior therapy or in first line treatment for patients unsuitable
for chemo-immunotherapy.1
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Following registration of BRUKINSA with the Australian
Therapeutic Goods Administration (TGA) in both approved
indications, these patients will have immediate access to BRUKINSA
through the BeiGene sponsored post-approval, pre-reimbursement
access program.
“Mantle cell lymphoma is an uncommon form of non-Hodgkin
lymphoma that is generally considered incurable. While the majority
of patients respond well to their initial treatment, virtually all
will develop progressive lymphoma over time. Existing therapies for
patients with recurrent or refractory MCL are often ineffective or
have side effects that can lead to treatment discontinuation,” said
Professor Stephen Opat, Director of Clinical Haematology at Monash
Health and a principal investigator in the zanubrutinib clinical
program. “I’m encouraged that zanubrutinib – a highly selective BTK
inhibitor with promising clinical results from two trials in
relapsed or refractory MCL – will provide a new treatment option
for these patients living in Australia.”
“Australia has some of the highest rates of non-Hodgkin’s
lymphoma in the world, and these patients need options for
treatment beyond those that exist today,” said Sharon Winton, CEO,
Lymphoma Australia. “MCL patients will certainly welcome the news
that BeiGene is providing access to BRUKINSA by sponsoring a
pre-reimbursement program, as new therapies are critical,
especially to those diagnosed later in life when it may be
challenging to tolerate more aggressive types of treatment.”
BeiGene submitted for reimbursement of BRUKINSA to the
Australian Pharmaceutical Benefits Advisory Committee (PBAC), with
MCL recommended for listing in July 2021.
“BRUKINSA was designed to provide deep and durable responses
while reducing off-target side effects compared to first-generation
BTK inhibitors,” said Jane Huang, M.D., Chief Medical Officer,
Hematology at BeiGene. “Our early BRUKINSA clinical trials started
in Australia and coming off the heels of BRUKINSA’s TGA
registration for the treatment of WM, we are delighted to be able
to provide BRUKINSA to more Australians in need of new treatment
options.”
More than 6,000 people are diagnosed with non-Hodgkin’s lymphoma
(NHL) in Australia each year, making it the sixth most common
cancer in adults.2 MCL is a B-cell NHL that develops in the outer
edge of a lymph node called the mantle zone.3 MCL usually has a
poor prognosis, with a median survival of three to six years, and
is often diagnosed at a later stage of disease.3
The Australian registration for BRUKINSA in MCL is based on
efficacy results from two single-arm clinical trials. Across both
trials, as assessed by independent review committee (IRC) per 2014
Lugano Classification, BRUKINSA achieved an overall response rate
(ORR) of 83.7%, defined as the combined rate of complete responses
(CRs) and partial responses (PRs).
In the multicenter Phase 2 trial of zanubrutinib in patients
with relapsed or refractory (R/R) MCL BGB-3111-206 (NCT03206970),
with a median follow-up time of 18.4 months, the ORR was 83.7% (95%
CI: 74.2, 90.8), including 68.6% CRs (FDG-PET scan required) and
15.1% PRs; the median duration of response (DoR) was 19.5 months
(95% CI: 16.6, NE). In the global Phase 1/2 trial BGB-3111-AU-003
(NCT02343120), with a media follow-up time of 14.75 months, the ORR
was 84.4% (95% CI: 67.2, 94.7), including 25.0% CRs (FDG-PET scan
not required) and 59.4% PRs; the median DoR was 18.5 months (95%
CI: 12.6, NE).
Of the 118 patients with MCL who received at least one prior
therapy and received BRUKINSA treatment, 13.6% of patients
discontinued treatment due to adverse events in the trials, with
the most frequent being pneumonia (3.4%). Adverse events leading to
dose reduction occurred in 3.4% of patients, including hepatitis B,
neutropenia, allergic dermatitis, and peripheral sensory neuropathy
(in one patient each).
The overall safety profile of BRUKINSA is based on pooled data
from 779 patients with B-cell malignancies treated with BRUKINSA in
clinical trials. The most common adverse reactions (≥20%) with
BRUKINSA were neutropenia, thrombocytopenia, upper respiratory
tract infection, hemorrhage/hematoma, rash, bruising, anemia,
musculoskeletal pain, diarrhea, pneumonia, and cough. The most
common Grade 3 or higher adverse reactions (≥5%) were neutropenia,
thrombocytopenia, pneumonia, and anemia.
The recommended dose of BRUKINSA is either 160 mg twice daily or
320 mg once daily, taken orally with or without food. The dose may
be adjusted for adverse reactions and reduced for patients with
severe hepatic impairment and certain drug interactions.
About BRUKINSA® (zanubrutinib)
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
synthesised, BRUKINSA was specifically designed to deliver complete
and sustained inhibition of the BTK protein by optimising
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 approved in the following indications and
regions:
- For the treatment of mantle cell lymphoma (MCL) in adult
patients who have received at least one prior therapy (United
States, November 2019)*;
- For the treatment of MCL in adult patients who have received at
least one prior therapy (China, June 2020)**;
- For the treatment of chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL) in adult patients who have
received at least one prior therapy (China, June 2020)**;
- For the treatment of relapsed or refractory MCL (United Arab
Emirates, February 2021);
- For the treatment of Waldenstr�m’s macroglobulinemia (WM) in
adult patients (Canada, March 2021);
- Registered and reimbursed for the treatment of MCL in patients
who have received at least one prior therapy (Israel, April
2021);
- For the treatment of adult patients with WM who have received
at least one prior therapy (China, June 2021)**;
- For the treatment of MCL in adult patients who have received at
least one prior therapy (Canada, July 2021);
- For the treatment of MCL in adult patients who have received at
least one prior therapy (Chile, July 2021);
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Brazil, August 2021);
- For the treatment of adult patients with WM (United States,
August 2021);
- For the treatment of adult patients with marginal zone lymphoma
(MZL) who have received at least one anti-CD20-based regimen
(United States, September 2021)*;
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Singapore, October 2021);
- For the treatment of adult patients with WM who have received
at least one prior therapy, or in first line treatment for patients
unsuitable for chemo-immunotherapy (Australia, October 2021);
and
- For the treatment of adult patients with MCL who have received
at least one prior therapy (Australia, October 2021).
To date, more than 30 marketing authorization applications in
multiple indications have been submitted in the United States,
China, the European Union, and more than 20 other countries or
regions.
* This indication was approved under accelerated approval based
on overall response rate. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in a confirmatory trial.
** This indication was approved under conditional approval.
Complete approval for this indication may be contingent upon
results from ongoing randomized, controlled confirmatory clinical
trials.
IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA
(ZANUBRUTINIB)
Warnings and Precautions
Hemorrhage
Fatal and serious hemorrhagic events have 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 3.4% of patients treated with BRUKINSA monotherapy.
Hemorrhage events of any grade occurred in 35% of patients treated
with BRUKINSA monotherapy.
Bleeding events have occurred in patients with and without
concomitant antiplatelet or anticoagulation therapy.
Co-administration 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) and opportunistic infections have occurred in patients with
hematological malignancies treated with BRUKINSA monotherapy. Grade
3 or higher infections occurred in 27% of patients, most commonly
pneumonia. 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 (26%),
thrombocytopenia (11%) and anemia (8%) based on laboratory
measurements, developed in patients treated with BRUKINSA
monotherapy. Grade 4 neutropenia occurred in 13% of patients, and
Grade 4 thrombocytopenia occurred in 3.6% 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 14% of patients treated with BRUKINSA monotherapy. The
most frequent second primary malignancy was non-melanoma skin
cancer, reported in 8% of patients. Other second primary
malignancies included malignant solid tumors (4.0%), melanoma
(1.7%) and hematologic malignancies (1.2%). Advise patients to use
sun protection and monitor patients for the development of second
primary malignancies.
Cardiac Arrhythmias
Atrial fibrillation and atrial flutter were reported in 3.2% of
patients treated with BRUKINSA monotherapy. Patients with cardiac
risk factors, hypertension, and acute infections may be at
increased risk. Grade 3 or higher events were reported in 1.1% of
patients treated with BRUKINSA monotherapy. Monitor signs and
symptoms for atrial fibrillation and atrial flutter and manage as
appropriate.
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, including laboratory
abnormalities, in ≥ 30% of patients who received BRUKINSA (N = 847)
included decreased neutrophil count (54%), upper respiratory tract
infection (47%), decreased platelet count (41%), hemorrhage (35%),
decreased lymphocyte count (31%), rash (31%) 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 moderate or
strong CYP3A inducers.
Specific Populations
Hepatic Impairment: The recommended dose of BRUKINSA for
patients with severe hepatic impairment is 80 mg orally twice
daily.
Please see full U.S. Prescribing Information at
www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at
www.beigene.com/PDF/BRUKINSAUSPPI.pdf.
BeiGene Oncology
BeiGene is committed to advancing hematology, immuno-oncology
and targeted therapies in order to bring impactful and affordable
medicines to patients across the globe. We have a growing R&D
team of approximately 2,300 colleagues dedicated to advancing more
than 90 clinical trials involving more than 13,000 patients and
healthy subjects. Our expansive portfolio is directed by a
predominantly internalised clinical development team supporting
trials in more than 40 countries or regions. We currently market
three medicines discovered and developed in our labs: BTK inhibitor
BRUKINSA in the United States, China, Canada, and additional
international markets; and non-FC-gamma receptor binding anti-PD-1
antibody tislelizumab and PARP inhibitor pamiparib in China.
BeiGene has a high quality, innovative science and medicine
organisation and is a leader in China with a large oncology focused
commercial team.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialise a range of oncology medicines in China licensed from
Amgen and Bristol Myers Squibb. We also plan to address greater
areas of unmet need globally through our collaborations including
with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen,
and Zymeworks. BeiGene has also entered into a collaboration with
Novartis granting Novartis rights to develop, manufacture, and
commercialise tislelizumab in North America, Europe, and Japan.
About BeiGene
BeiGene is a global, science-driven biotechnology company
focused on developing innovative and affordable medicines to
improve treatment outcomes and access for patients worldwide. With
a broad portfolio of more than 40 clinical candidates, we are
expediting development of our diverse pipeline of novel
therapeutics through our own capabilities and collaborations. We
are committed to radically improving access to medicines for two
billion more people by 2030. BeiGene has a growing global team of
over 7,000 colleagues across five continents. To learn more about
BeiGene, please visit www.beigene.com.au 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
plans for development and commercialisation of BRUKINSA in
Australia, the APAC region and other markets, the potential
commercial opportunity for BRUKINSA, plans for making BRUKINSA
accessible to patients in Australia, the potential for BRUKINSA to
provide improved clinical benefits to patients, 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 commercialising
pharmaceutical products and its ability to obtain additional
funding for operations and to complete the development and
commercialisation of its drug candidates and achieve and maintain
profitability; the impact of the COVID-19 pandemic on the BeiGene’s
clinical development, regulatory, commercial, 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:
- BRUKINSA Australia Product Information. Available at
https://www.beigene.com.au/PDF/BRUKINSAAUPI.pdf. Accessed October
2021.
-
https://www.lymphoma.org.au/types-of-lymphoma/non-hodgkin-lymphoma.
Accessed August 2021.
-
https://www.lls.org/sites/default/files/2021-05/FS4_MCL_Facts_Rev.pdf.
Accessed August 2021.
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BeiGene Corporate Contacts Investor Contact
Gabrielle Zhou +86 10-5895-8058 ir@beigene.com Media Contact
Vivian Ni +1 857-302-7596 media@beigene.com
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