BRUKINSA is the first and only BTK inhibitor
approved across five oncology indications and the first and only
approved in follicular lymphoma
Approval based on positive results from
ROSEWOOD trial showing BRUKINSA plus obinutuzumab achieved higher
overall response rate versus obinutuzumab alone
BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced that the U.S. Food and Drug
Administration (FDA) has granted accelerated approval to BRUKINSA®
(zanubrutinib) for the treatment of adult patients with relapsed or
refractory (R/R) follicular lymphoma (FL), in combination with the
anti-CD20 monoclonal antibody obinutuzumab, after two or more lines
of systemic therapy. The indication is approved under accelerated
approval based on response rate and durability of response, marking
BRUKINSA’s fifth indication in B-cell malignancies in the U.S.
“This accelerated approval of BRUKINSA represents an important
advancement, offering the first and only BTK inhibitor treatment
for follicular lymphoma patients in the U.S. who have either not
responded to initial therapies or have experienced relapse,” said
Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology
at BeiGene. “BRUKINSA is the only BTK inhibitor to date that shows
efficacy with this type of malignancy and now has the broadest
label, including five oncology indications, of any medication in
its class globally. This is a testament to BRUKINSA’s
differentiated clinical profile and our continued commitment to
bringing this much-needed treatment option to patients around the
world.”
BRUKINSA was approved for the treatment of R/R FL under the
FDA’s accelerated approval program based on the overall response
rate (ORR) from the ROSEWOOD trial (NCT03332017), as assessed by an
independent review committee (IRC). Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory MAHOGANY (NCT05100862) trial,
which is underway. The application for R/R FL was also granted Fast
Track Designation and Orphan Drug Designation by the FDA.
The ROSEWOOD trial is a global, randomized, open-label Phase 2
study of BRUKINSA plus obinutuzumab compared with obinutuzumab
alone in 217 patients with R/R FL who received at least two prior
lines of systemic therapy. In the study, the ORR by IRC was 69% in
the BRUKINSA plus obinutuzumab arm versus 46% in the obinutuzumab
arm (P=0.0012), with a median follow-up of approximately 20 months.
Responses were durable, with an 18-month landmark duration of
response (DOR) of 69% in the BRUKINSA combination arm.i
BRUKINSA plus obinutuzumab was generally well-tolerated, with
safety results consistent with previous studies of both medicines.i
Serious adverse reactions occurred in 35% of patients who received
BRUKINSA in combination with obinutuzumab. Adverse reactions led to
permanent discontinuation of BRUKINSA in 17% of patients.
Christopher Flowers, M.D., Division Head of Cancer Medicine and
Chair of the Department of Lymphoma/Myeloma, The University of
Texas MD Anderson Cancer Center commented, “Patients living with
follicular lymphoma often experience relapse or do not respond to
treatment and need options for treatment during the course of their
illness. The findings from the ROSEWOOD trial highlight the
significant clinical advantage of treating patients who experience
relapse or have refractory follicular lymphoma with zanubrutinib
plus obinutuzumab.”
“Follicular lymphoma can significantly impact patients' lives
and prove to be challenging, especially for those whose condition
has advanced despite undergoing prior treatment or experienced
relapse,” said the Follicular Lymphoma Foundation. “However, the
emergence of new treatment options which have been shown to be
effective and well-tolerated, including second generation BTK
inhibitors such as zanubrutinib in combination with existing
therapies, brings hope to those dealing with advanced follicular
lymphoma.”
In addition to R/R FL, BRUKINSA is also approved in the U.S. as
a treatment for adult patients with Waldenstr�m’s
macroglobulinemia; mantle cell lymphoma, who have received at least
one prior therapy, R/R marginal zone lymphoma, who have received at
least one anti-CD20-based regimen; and most recently chronic
lymphocytic leukemia or small lymphocytic lymphoma. BRUKINSA is the
first and only BTK inhibitor to demonstrate PFS superiority in a
head-to-head clinical trial versus ibrutinib in patients with R/R
CLL in the global Phase 3 ALPINE trial. In a recent presentation,
BRUKINSA showed sustained PFS benefit versus ibrutinib in a longer
term follow up. Durable PFS was observed across major subgroups,
including in the high-risk 17p deletion/TP53 mutated patient
population.
BRUKINSA is approved in 70 markets, including the U.S., EU,
Great Britain, Canada, Australia, China, South Korea and
Switzerland in selected indications, and it is under development
for additional indications globally. The global BRUKINSA
development program includes more than 5,000 subjects enrolled to
date in 29 countries and regions.
About Follicular Lymphoma
Follicular lymphoma (FL) is the second most common type of
non-Hodgkin lymphoma (NHL), accounting for 22% of all NHL cases.ii
Approximately 15,000 cases are diagnosed in the U.S. each year.iii
While FL remains incurable, people with the condition can live a
long time. The five-year survival rate is about 90%, and
approximately half of people diagnosed with FL can live with the
disease for nearly 20 years.iv
About BRUKINSA® (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine
kinase (BTK) designed to deliver complete and sustained inhibition
of the BTK protein by optimizing bioavailability, half-life, and
selectivity. With differentiated pharmacokinetics compared with
other approved BTK inhibitors, BRUKINSA has been demonstrated to
inhibit the proliferation of malignant B cells within a number of
disease-relevant tissues.
U.S. Indications and Important Safety Information for
BRUKINSA (zanubrutinib)
INDICATIONS
BRUKINSA is a kinase inhibitor indicated for the treatment of
adult patients with:
- Chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL).
- 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.
- Relapsed or refractory follicular lymphoma (FL), in combination
with obinutuzumab, after two or more lines of systemic
therapy.
The MCL, MZL and FL indications are approved under accelerated
approval based on overall response rate and durability of response.
Continued approval for these indications may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
IMPORTANT SAFETY
INFORMATION
Warnings and Precautions
Hemorrhage
Fatal and serious hemorrhage has occurred in patients with
hematological malignancies treated with BRUKINSA. Grade 3 or higher
hemorrhage including intracranial and gastrointestinal hemorrhage,
hematuria, and hemothorax was reported in 3.8% of patients treated
with BRUKINSA in clinical trials, with fatalities occurring in 0.2%
of patients. Bleeding of any grade, excluding purpura and
petechiae, occurred in 32% 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 before and after
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.
Grade 3 or higher infections occurred in 26% of patients, most
commonly pneumonia (7.9%), with fatal infections occurring in 3.2%
of patients. Infections due to hepatitis B virus (HBV) reactivation
have occurred.
Consider prophylaxis for herpes simplex virus, pneumocystis
jirovecii 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 (21%),
thrombocytopenia (8%) and anemia (8%) based on laboratory
measurements, developed in patients treated with BRUKINSA. Grade 4
neutropenia occurred in 10% of patients, and Grade 4
thrombocytopenia occurred in 2.5% 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. The most
frequent second primary malignancy was non-melanoma skin cancers
(8%), followed by other solid tumors in 7% of the patients
(including melanoma in 1% of patients) and hematologic malignancies
(0.7%). 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 4.4% patients treated with BRUKINSA, including Grade 3 or higher
cases in 1.9% 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 0.3% of
patients.
Monitor for signs and symptoms of 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, in patients who received BRUKINSA (N=1729) are
decreased neutrophil count (51%), decreased platelet count (41%),
upper respiratory tract infection (38%), hemorrhage (32%), and
musculoskeletal pain (31%).
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
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 including U.S.
Patient Information.
About BeiGene
BeiGene is a global oncology company that is discovering and
developing innovative 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
10,000 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 LinkedIn and
X (formerly known as Twitter).
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 ability and commitment to bring BRUKINSA to patients
around the world; the significance of the clinical advantages of
treating R/R FL patients with BRUKINSA plus obinutuzumab; BeiGene’s
advancement, anticipated clinical development, regulatory
submissions and commercialization of zanubrutinib, particularly as
a treatment for R/R FL; 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,
commercialization, and other services; BeiGene’s limited experience
in obtaining regulatory approvals and commercializing
pharmaceutical products; BeiGene’s ability to obtain additional
funding for operations and to complete the development of its drug
candidates and achieve and maintain profitability; and those risks
more fully discussed in the section entitled “Risk Factors” in
BeiGene’s most recent annual report on Form 10-K, 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
i Zinsani PL, et al. ROSEWOOD: A Phase II Randomized Study of
Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in
Patients With Relapsed or Refractory Follicular Lymphoma. J Clin
Oncol. 2023;41(33):5107-5117.
iiLeukemia & Lymphoma Society. Treatment for Indolent NHL
Subtypes. Accessed February 16, 2024. Available at:
https://www.lls.org/lymphoma/non-hodgkin-lymphoma/nhl-subtypes/treatment-indolent-nhl-subtypes.
iii Leukemia & Lymphoma Society. Follicular Lymphoma (FL).
Accessed February 16, 2024. Available at:
https://www.lls.org/research/follicular-lymphoma-fl#:~:text=FL%20has%20an%20annual%20incidence,having%20a%20higher%20survival%20rate.
iV Cleveland Clinic. Follicular Lymphoma. March 25, 2022.
Accessed February 16, 2024. Available at:
https://my.clevelandclinic.org/health/diseases/22606-follicular-lymphoma.
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