Two global Phase 3 trials in adults with
CLL demonstrated superior efficacy for BRUKINSA in
first line and relapsed/refractory settings
TORONTO, May 30, 2023
/CNW/ - BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) (SSE:
688235), a global biotechnology company, announced today that
BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase (BTK)
inhibitor, has been granted a Notice of Compliance from Health
Canada for the treatment of adult patients with chronic lymphocytic
leukemia (CLL).
This is the fourth Canadian approval for BRUKINSA, following
authorizations for: adult patients with Waldenström's
macroglobulinemia; adult patients who have received at least one
prior therapy for the treatment of mantle cell lymphoma; and adult
patients with relapsed or refractory marginal zone
lymphoma.1
The latest Health Canada approval of BRUKINSA for CLL is based
on positive efficacy results and a favourable safety profile from
two global Phase 3, randomized, open-label, multicentre clinical
trials: SEQUOIA (NCT03336333), comparing single agent zanubrutinib
against the chemotherapy agent, 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.1
Typically diagnosed among individuals in their early 70s, CLL is
a slow-growing, incurable blood cancer and is the most common
leukemia in adults.2
"Because CLL is a chronic disease with many patients often
living with multiple health conditions, access to effective
treatment options with safe and favourable 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 also
delivered superior efficacy vs 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
these patients."
In the SEQUOIA trial, which examined those with previously
untreated CLL, zanubrutinib achieved its primary endpoint,
demonstrating a statistically significant improvement in
progression free survival (PFS) compared to BR, at median follow-up
of approximately 26.2 months.1
Zanubrutinib met its primary endpoint in the interim ALPINE
analysis demonstrating a superior overall response rate (ORR) of
78.3% vs. 62.5% (95% CI and p-value) compared to ibrutinib at 12
months.1 Moreover, the incidence of atrial
fibrillation and flutter of any grade in the interim ALPINE
analysis was substantially lower with zanubrutinib vs. ibrutinib
(2% vs 8%).1
Considered the largest head-to-head study of BTK inhibitors in
R/R CLL, the final ALPINE trial data was 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
"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."
If anyone knows the importance of community when you receive a
cancer diagnosis it would be Jamie
Campbell. The veteran Toronto Blue Jays commentator and host
of Blue Jays Central on Sportsnet was diagnosed with CLL two years
ago and began treatment last year. "The fans and my baseball family
really got behind me and lifted me up when I needed it most and
they still are," says Campbell. "And though the mental "hug" you
get from family and friends helps with managing the disease, it's
just as important to have choices when it comes to treatment
options because patients have different needs and are at different
stages of their disease."
"BeiGene Canada is proud of our company's ongoing focus and
commitment to researching and developing innovative oncology
therapies," says Peter Brenders,
General Manager, BeiGene Canada. "The development of treatments
like zanubrutinib reflects BeiGene's dedication to finding better
ways to improve the lives of cancer patients and their
families."
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. When most of the cancer
cells are found in the blood stream and the bone marrow, it is
called CLL.
About BRUKINSA
(zanubrutinib)
BRUKINSA blocks a specific protein in the body that helps cancer
cells live and grow. This protein is called "Bruton's Tyrosine
Kinase". By blocking this protein, BRUKINSA may help kill and
reduce the number of cancer cells and slow the spread of the
cancer.
BRUKINSA 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
protein is continuously synthesized, BRUKINSA was specifically
designed by BeiGene to deliver complete 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 several disease
relevant tissues and is indicated in Canada for the treatment of adult patients
with: Waldenström's macroglobulinemia; mantle cell lymphoma who
have received at least one prior therapy; marginal zone lymphoma
who have received at least one prior anti-CD20-based therapy; and,
CLL.
For adult patients with CLL, BRUKINSA is dosed as two 80 mg
capsules taken orally twice a day (twelve hours apart) OR four 80
mg capsules taken once a day.
About BeiGene Canada
Headquartered in Toronto, Ontario, BeiGene Canada is the country
affiliate of global biotechnology company BeiGene, specialized in
the discovery and development of novel, affordable and accessible
oncology medications. With a highly experienced and dedicated
Canadian leadership team headed by pharmaceutical
executive Peter Brenders, BeiGene Canada is committed to
delivering new cancer therapies to the Canadian oncology community,
including patients, caregivers, clinicians, and investigators. For
more information about BeiGene Canada please
visit www.beigene.ca.
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.
About myBeiGene®
Patient Support Program
The myBeiGene® patient support program is designed to
support patients, caregivers, and healthcare providers with access
to BRUKINSA. It goes beyond financial assistance support to provide
patients and caregivers with education about their disease and
treatment with BRUKINSA, as well provide practical and emotional
support by connecting them to third-party resources that can
address their individual needs. Oncology Case Managers are
available Monday through Friday from 8 a.m.
to 8 p.m. Eastern Time at 1-833-234-4366.
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 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 SAFETY
INFORMATION
Indications & Clinical Use:
BRUKINSA (zanubrutinib) is indicated:
- for the treatment of adult patients with Waldenström's
macroglobulinemia;
- for the treatment of adult patients with mantle cell lymphoma
who have received at least one prior therapy;
- for the treatment of adult patients with marginal zone lymphoma
who have received at least one prior anti-CD20-based therapy;
and,
- for the treatment of adult patients with CLL.
Pediatrics (<18 years of age): No safety and
efficacy data are available; therefore, Health Canada has not
authorized an indication for pediatric use.
Geriatrics (>65 years of age): No clinically
relevant differences in safety or efficacy were observed between
patients ≥65 years and those younger than 65 years.
Contraindications:
BRUKINSA is contraindicated in patients who are hypersensitive
to zanubrutinib or to any ingredient in the formulation, including
any non-medicinal ingredient, or component of the container.
Most Serious Warnings and
Precautions:
Healthcare professional supervision
required: Treatment with BRUKINSA should be initiated and
supervised by a Qualified Healthcare Practitioner experienced in
the use of anticancer therapies.
Serious hemorrhage: (see the BRUKINSA Product
Monograph, WARNINGS AND PRECAUTIONS, Hemorrhage).
Other Relevant Warnings and
Precautions:
Second primary malignancies: Monitor patients for
skin cancer and advise patients to use sun protection.
Atrial fibrillation and flutter: Monitor for signs
and symptoms of atrial fibrillation and atrial flutter and manage
as appropriate.
Driving and operating machinery: Fatigue, dizziness,
and asthenia have been reported in some patients taking BRUKINSA
and should be considered when assessing a patient's ability to
drive or operate machines.
Cytopenias: Monitor complete blood counts regularly
during treatment.
Infections: Monitor patients for signs and symptoms
of infection and treat appropriately. Consider prophylaxis
according to standard of care in patients who are at increased risk
for infections.
Tumour lysis syndrome: Monitor patients closely and treat
as appropriate.
Peri-operative considerations: Consider the
benefit-risk of withholding BRUKINSA for 3 to 7 days pre- and
post-surgery depending upon the type of surgery and the risk of
bleeding.
Fertility: No data on the effects of BRUKINSA on
fertility in humans are available.
Teratogenic risk: Advise women of the potential
hazard to a fetus and to avoid becoming pregnant during treatment
and for at least 1 week after the last dose of BRUKINSA. Advise men
to avoid fathering a child while receiving BRUKINSA and for at
least 3 months following the last dose of BRUKINSA.
Breastfeeding: Advise lactating women not to
breastfeed during treatment with BRUKINSA and for at least two
weeks following the last dose.
Interstitial lung disease (ILD): Monitor patients
for signs and symptoms of ILD.
Hemorrhage: Patients should be monitored for signs
of bleeding.
For More Information:
Please consult the BRUKINSA Product Monograph at
BRUKINSA.ca/PM for important information relating to adverse
reactions, drug interactions, and dosing information, which have
not been discussed in this piece.
The Product Monograph is also available by calling
1-877-828-5598.
References
___________________________
1 BRUKINSA
(zanubrutinib) Canada Product Monograph. May 23, 2023. Available
at: https://pdf.hres.ca/dpd_pm/00070886.PDF
|
2 Lymphoma
Canada www.lymphoma.ca/lymphoma/cll-sll/about-cll-sll/
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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.
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SOURCE BeiGene Canada