New network meta-analysis demonstrates
favorable progression-free survival for patients treated with
BRUKINSA vs other BTKi's
Analysis of Kaiser Permanente database shows
BRUKINSA effective and generally well tolerated, including in
patients switching to BRUKINSA from ibrutinib
ALPINE post hoc analysis shows less frequent
initiation of new antihypertensives or a new class of
antihypertensives in patients treated with BRUKINSA vs.
ibrutinib
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced the presentation of new analyses
for BRUKINSA® (zanubrutinib) at the American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago, May 31 - June 4, 2024.
The presentations highlight analyses of the efficacy and safety of
BRUKINSA compared to other Bruton’s tyrosine kinase inhibitors
(BTKis) used to treat chronic lymphocytic leukemia (CLL) and small
lymphocytic lymphoma (SLL).
“At this year’s ASCO, multiple presentations continue to add to
our extensive body of evidence demonstrating BRUKINSA’s uniquely
differentiated clinical profile,” Mehrdad Mobasher, M.D., M.P.H.,
Chief Medical Officer, Hematology at BeiGene. “These new analyses,
which highlight improved PFS and response rates and a low usage of
antihypertensive medicines, provide valuable insights for
oncologists to consider when making treatment decisions for their
patients with CLL and SLL.”
BRUKINSA Survival and Response Rates for CLL vs.
Acalabrutinib and other BTKis in a Network Meta-Analysis
A network meta-analysis evaluated the relative efficacy of
available treatments for patients with high-risk
relapsed/refractory (R/R) CLL using data from three randomized
controlled clinical trials: ALPINE, ELEVATE-RR and ASCEND. The
analysis found a statistically significant improvement in PFS for
BRUKINSA over acalabrutinib in high-risk patients and a trend
toward improvement in overall survival (OS), overall response (ORR)
and complete response (CR). BRUKINSA led to statistically
significant improvements in PFS, as well as a trend toward
improvement in OS, vs. ibrutinib and bendamustine +
rituximab/idelalisib + rituximab (BR/IR).
“Given the lack of head-to-head trials comparing BTK inhibitors
in high-risk R/R CLL patients, we undertook a network meta-analysis
to estimate the relative efficacy of available treatments,” said
Mazyar Shadman, M.D. M.P.H, Associate Professor and Innovators
Network Endowed Chair, Assistant Medical Director, Cellular
Immunotherapy, Fred Hutch Cancer Center and University of
Washington. “We found zanubrutinib to be the most efficacious BTKi
for patients with high-risk R/R CLL, offering significantly delayed
disease progression and favorable response compared with the other
BTKi treatments in the analysis, including acalabrutinib.”
Network meta-analyses are intended to be hypothesis-generating,
and do not establish superior efficacy or safety of one drug over
another. Results should be viewed in the context of analysis
limitations and available randomized clinical trial data.
- This poster will be presented Monday, June 3, from 9 a.m. –
noon CT (Abstract #7048).
BRUKINSA Effective and Generally Well-Tolerated for Patients
with CLL/SLL Regardless of Prior Ibrutinib Use
A retrospective analysis assessed treatment patterns,
treatment-emergent adverse events (TEAEs), treatment-limiting
adverse events (TLAEs) and treatment-related mortality among
patients with CLL/SLL treated at Kaiser Permanente Northern
California. Among 281 patients who received BRUKINSA, 190 switched
from ibrutinib and 91 received only BRUKINSA, with a median follow
up of 24.4 and 8.2 months, respectively. Similar TEAE rates were
seen with both BTKi therapies, with lower TLAE rates with BRUKINSA.
Cardiac TLAE and non-TLAE rates overall were higher with ibrutinib
than BRUKINSA, and the rates decreased after switching to BRUKINSA.
There were no reports of treatment-related deaths.
- This poster will be presented Monday, June 3, from 9 a.m. –
noon CT (Abstract #11158).
ALPINE Post Hoc Analysis Shows Less Frequent Initiation of
Anti-hypertensive Medications in Patients Treated with BRUKINSA vs.
Ibrutinib
A post-hoc analysis of the ALPINE clinical trial data evaluated
the risk of developing hypertension based on initiation of
anti-hypertensive medications among patients with CLL/SLL treated
with BRUKINSA vs. ibrutinib. The analysis found that initiation of
new anti-hypertensives or a new class of anti-hypertensives
occurred less frequently in the BRUKINSA arm vs. the ibrutinib arm.
In addition, initiation of anti-hypertensives occurred sooner for
patients treated with ibrutinib vs. BRUKINSA. Data from this
analysis provide important insights when evaluating the overall
safety profile of individual BTKi treatments.
- This abstract is available online (Abstract #e19016).
During the meeting, BeiGene will also sponsor a virtual panel
discussion featuring perspectives from leading hematology/oncology
experts as they discuss the BTKi treatment evolution, and the
considerations healthcare providers and patients should weigh when
choosing treatment for CLL. The panel, titled “Exploring the
landscape of next-generation BTK inhibitors in blood cancers” will
take place during the Endpoints at #ASCO24 event on June 4 at 12:35
– 1:05 p.m. ET (register here).
For additional information about BeiGene’s presence at the 2024
ASCO Annual Meeting, please visit our meeting hub in our
newsroom.
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.
To learn more about BeiGene, please visit www.beigene.com and
follow us on LinkedIn, X (formerly known as Twitter), and
Facebook.
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 BRUKINSA’s
differentiated clinical profile; the efficacy of zanubrutinib for
patients with high-risk R/R CLL compared to other BTKi treatments;
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 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.
To access BeiGene media resources, please visit our News
& Media site.
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version on businesswire.com: https://www.businesswire.com/news/home/20240524702722/en/
Investor: Liza Heapes +1 857-302-5663 ir@beigene.com
Media: Kyle Blankenship +1 667-351-5176
media@beigene.com
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