This marks the second FDA approval for BRUKINSA
and its third approval in Waldenstr�m’s macroglobulinemia
globally
The approval is based on Phase 3 ASPEN trial
comparing BRUKINSA against ibrutinib
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global
biotechnology company focused on developing and commercializing
innovative medicines worldwide, today announced that BRUKINSA®
(zanubrutinib) has received approval from the U.S. Food and Drug
Administration (FDA) for the treatment of adult patients with
Waldenstr�m’s macroglobulinemia (WM).
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“We are delighted by today’s FDA approval for BRUKINSA in its
second indication, offering a new treatment option with
demonstrated efficacy and safety benefits for patients with
Waldenstr�m’s macroglobulinemia. As shown in the ASPEN trial,
BRUKINSA can improve treatment outcomes for these patients and
potentially make a positive impact on their lives,” commented Jane
Huang, M.D., Chief Medical Officer, Hematology at BeiGene.
Dr. Huang continued, “With 11 regulatory approvals in under two
years, including two in the U.S., BRUKINSA is demonstrating its
growing utility as a treatment option for B-cell malignancies and
expanding its footprint to potentially benefit more patients
worldwide. We will continue to evaluate BRUKINSA in its broad
global clinical program and look forward to additional clinical
evidence to establish its position as a potentially best-in-class
medicine.”
“The ASPEN trial provided compelling evidence that BRUKINSA is a
highly active BTK inhibitor in Waldenstr�m’s macroglobulinemia, and
compared to the first-generation BTK inhibitor, showed improved
tolerability across a number of clinically important side effects.
The approval of BRUKINSA provides an important new option for
targeted therapy in Waldenstr�m’s macroglobulinemia,” said Steven
Treon, M.D., Ph.D., Director of the Bing Center for Waldenstr�m’s
Macroglobulinemia Research at the Dana-Farber Cancer Institute and
Professor of Medicine at Harvard Medical School.
“The approval of BRUKINSA in Waldenstr�m’s macroglobulinemia,
which is the second therapy approved specifically for the treatment
of this rare type of lymphoma, is positive news for patients.
Expanded treatment options offer new hope for those living with
this disease and can potentially improve patient experience,
especially oral therapies that can be given as a single agent,”
said Pete DeNardis, Chair of the Board at the International
Waldenstr�m’s Macroglobulinemia Foundation (IWMF).
The FDA’s approval of BRUKINSA in WM is primarily based on
efficacy results from the multicenter, open-label Phase 3 ASPEN
trial (NCT03053440) comparing BRUKINSA to ibrutinib in patients
with WM. A total of 201 patients with a MYD88 mutation (MYD88MUT)
were enrolled in the randomized Cohort 1.
The primary efficacy endpoint of the ASPEN trial was very good
partial response (VGPR) rate in the overall intention-to-treat
(ITT) population as assessed by independent review committee (IRC).
Based on the modified Sixth International Workshop on Waldenstr�m’s
Macroglobulinemia (IWWM-6) response criteria (Treon 2015), the VGPR
rate was 28% with BRUKINSA, compared to 19% with ibrutinib; based
on the IWWM-6 response criteria (Owen et al 2013), the VGPR rate
was 16% with BRUKINSA, compared to 7% with ibrutinib.
In the FDA-approved label, the major efficacy outcome is defined
as response rate of partial response (PR) or better as assessed by
IRC. Based on either IWWM-6 response criteria, the response rate
was 78% with BRUKINSA (95% CI: 68, 85), compared to 78% with
ibrutinib (95% CI: 68, 86), and the event-free duration of response
(DoR) at 12 months was 94% with BRUKINSA (95% CI: 86, 98), compared
to 88% with ibrutinib (95% CI: 77, 94).
The most common (≥20%) adverse reactions based on the pooled
safety population of 779 patients were decreased neutrophil count,
upper respiratory tract infection, decreased platelet count, rash,
hemorrhage, musculoskeletal pain, decreased hemoglobin, bruising,
diarrhea, pneumonia, and cough.
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
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 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 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 adult patients with MCL who have received
at least one previous therapy (Brazil, August 2021); and
- For the treatment of adult patients with WM (United States,
August 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 3.0% 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 28% of patients treated with
BRUKINSA monotherapy. The most common Grade 3 or higher infection
was 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 (28%),
thrombocytopenia (11%) and anemia (7%) based on laboratory
measurements, were reported in patients treated with BRUKINSA
monotherapy. Grade 4 neutropenia occurred in 13% of patients, and
Grade 4 thrombocytopenia occurred in 4% 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 (4%), melanoma (1.4%),
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 have occurred in 2.8% 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 0.8% 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 ≥20% of patients who received BRUKINSA (N = 779)
were decreased neutrophil count (56%), upper respiratory tract
infection (49%), decreased platelet count (44%), rash (35%),
hemorrhage (35%), musculoskeletal pain (30%), decreased hemoglobin
(28%), bruising (25%), diarrhea (23%), pneumonia (22%), and cough
(21%).
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
https://www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient
Information at
https://www.beigene.com/PDF/BRUKINSAUSPPI.pdf.
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 team of approximately 2,300
colleagues dedicated to advancing more than 90 clinical trials
involving more than 13,000 patients and healthy volunteers. Our
expansive portfolio is directed by a predominantly internalized
clinical development team supporting trials in more than 40
countries. 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. 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 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 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
commercialize 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 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
BeiGene's plan for the advancement, and anticipated clinical
development, regulatory milestones and commercialization of
BRUKINSA, 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 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; 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.
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BeiGene Contacts Investor Contact Gabrielle Zhou
+86 10-5895-8058 or +1 857-302-5189 ir@beigene.com
Media Contact Liza Heapes or Vivian Ni +1 857-302-5663 or
+1 857-302-7596 media@beigene.com
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