U.S. label update includes superior
progression-free survival results from the Phase 3 ALPINE
head-to-head trial of BRUKINSA versus IMBRUVICA® (ibrutinib) in
Relapsed or Refractory CLL
ALPINE is the only Phase 3 Bruton’s tyrosine
kinase (BTK) inhibitor trial to demonstrate superiority versus
IMBRUVICA
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced the U.S. Food and Drug
Administration (FDA) has approved a label update for BRUKINSA®
(zanubrutinib) to include superior progression-free survival (PFS)
results from the Phase 3 ALPINE trial comparing BRUKINSA against
IMBRUVICA® (ibrutinib) in previously treated patients with relapsed
or refractory (R/R) chronic lymphocytic leukemia (CLL).
“The ALPINE trial is the first and only study to demonstrate PFS
superiority in a head-to-head comparison versus ibrutinib in CLL,”
said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer,
Hematology at BeiGene. “BRUKINSA was approved in the U.S. for CLL
at the beginning of 2023, and we submitted additional data from the
ALPINE PFS analysis supporting it as the BTK inhibitor of choice in
CLL, solidifying it as an important treatment option for patients.
When making treatment decisions, it is critical that physicians and
patients understand the totality of data supporting BRUKINSA’s
robust efficacy and differentiated safety in CLL.”
The updated label is based on a prespecified analysis of the
ALPINE trial, which demonstrated superior efficacy and a favorable
cardiac safety profile for BRUKINSA versus ibrutinib in patients
with R/R CLL and was presented in a late-breaking session at the
64th Annual American Society for Hematology (ASH) Meeting and
Exposition and published simultaneously in The New England Journal
of Medicine. The updated label includes data at a median follow-up
of 31 months, in which BRUKINSA demonstrated superior PFS compared
with ibrutinib in patients with R/R CLL (HR: 0.65 [95% CI,
0.49-0.86] P=.0024, for both investigator and independent review
committee). Additionally, BRUKINSA demonstrated a favorable cardiac
safety profile with significantly lower rates of atrial
fibrillation/flutter (5.2% vs. 13.3%) and zero deaths due to
cardiac disorders with BRUKINSA versus six with ibrutinib (0% vs.
1.9%).
Please see Important Safety Information below.
At the recent 65th Annual ASH Meeting and Exposition, BeiGene
presented extended follow-up data from the ALPINE trial at a median
follow-up of 39 months. The data demonstrate that BRUKINSA
continues to show sustained PFS benefit versus ibrutinib (HR: 0.68
[95% CI, 0.53-0.86] P=0.0011) among R/R CLL patients receiving more
than three years of treatment, with durable PFS benefits observed
across subgroups, including patients with 17p deletion or TP53
mutation (HR: 0.52 [95% CI, 0.33-0.83] P=0.0047). PFS benefit is
consistent across multiple sensitivity analyses, demonstrating that
PFS advantage with BRUKINSA was primarily driven by efficacy and
not tolerability. The overall safety and tolerability profile was
consistent with previous ALPINE analyses, including persistently
lower rates of cardiovascular events reported with BRUKINSA. The
most commonly reported treatment emergent adverse events (≥20%)
with BRUKINSA were COVID-19-related, neutropenia, hypertension, and
upper respiratory tract infection.
BRUKINSA is approved in more than 65 countries, including the
U.S., China, EU, Great Britain, Canada, Australia, South Korea, and
Switzerland, in selected indications and under development for
additional indications globally. In the U.S., BRUKINSA is approved
for the treatment of adult patients with CLL or small lymphocytic
lymphoma, Waldenstr�m’s macroglobulinemia, mantle cell lymphoma who
have received at least one prior therapy, and relapsed or
refractory marginal zone lymphoma who have received at least one
anti-CD20-based regimen. The global BRUKINSA development program
includes more than 5,000 subjects enrolled to date in 29 countries
and regions.
About Chronic Lymphocytic Leukemia (CLL) A
life-threatening cancer of adults, CLL is a type of mature B-cell
malignancy in which abnormal leukemic B lymphocytes (a type of
white blood cells) arise from the bone marrow and flood peripheral
blood, bone marrow, and lymphoid tissues.i,ii CLL is the most
common type of leukemia in adults, accounting for about one-quarter
of new cases of leukemia.ii,iii Approximately 18,740 new cases of
CLL will be diagnosed in the United States in 2023.iii
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
The MCL and MZL indications are approved under accelerated
approval based on overall response rate. 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
monotherapy. Grade 3 or higher hemorrhage, including intracranial
and gastrointestinal hemorrhage, hematuria and hemothorax have been
reported in 3.6% of patients treated with BRUKINSA monotherapy in
clinical trials, with fatalities occurring in 0.3% of patients.
Bleeding of any grade, excluding purpura and petechiae, occurred in
30% 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 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 infections) and opportunistic
infections have occurred in patients with hematological
malignancies treated with BRUKINSA monotherapy. Grade 3 or higher
infections occurred in 24% of patients, most commonly pneumonia
(11%), with fatal infections occurring in 2.9% of patients.
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
(22%), thrombocytopenia (8%) and anemia (7%) based on laboratory
measurements, developed in patients treated with BRUKINSA
monotherapy. Grade 4 neutropenia occurred in 11% of patients, and
Grade 4 thrombocytopenia occurred in 2.8% 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
(5%), melanoma (1.2%), and hematologic malignancies (0.5%). 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 3.7% of 1550 patients treated with
BRUKINSA monotherapy, including Grade 3 or higher cases in 1.7% 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 0.2% 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 In this pooled safety population, the
most common adverse reactions, including laboratory abnormalities,
in ≥30% of patients who received BRUKINSA (N=1550) included
decreased neutrophil count (42%), upper respiratory tract infection
(39%), decreased platelet count (34%), hemorrhage (30%), 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 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 and
U.S. Patient Information.
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 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 whether BRUKINSA is
the BTK inhibitor of choice in CLL and its importance as a
treatment option for patients; the efficacy and safety profile of
BRUKINSA for patients with CLL; 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 and its 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.
IMBRUVICA® is a registered trademark of Pharmacyclics LLC and
Janssen Biotech, Inc.
i National Cancer Institute. Chronic
Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed
November 2023.
https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq.
ii American Cancer Society. What is
Chronic Lymphocytic Leukemia? Updated May 10, 2018. Accessed
November 2023.
https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html.
iii American Cancer Society. Key
Statistics for Chronic Lymphocytic Leukemia. Updated January 12,
2023. Accessed November 2023.
https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/key-statistics.html.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231222742110/en/
Investor: Liza Heapes +1 857-302-5663 ir@beigene.com
Media: Kyle Blankenship +1 667-351-5176
media@beigene.com
BeiGene (NASDAQ:BGNE)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
BeiGene (NASDAQ:BGNE)
Gráfica de Acción Histórica
De May 2023 a May 2024