5-year follow-up from SEQUOIA study
demonstrated treatment with BRUKINSA reduced the risk of
progression or death by 71% compared to bendamustine-rituximab in
patients with treatment-naïve CLL, further solidifying its position
as the leader in new patient starts in both frontline and
relapsed/refractory (R/R) CLL with the broadest label of any BTK
inhibitor
At a median follow-up of 1.5 years, promising
data from the 320 mg expansion cohort of phase 1/1b study shows no
progression in patients with treatment-naïve CLL treated with
sonrotoclax, a next-generation BCL2 inhibitor, in combination with
BRUKINSA highlighting the potential of this fixed-duration,
oral-only combination as a best-in-disease option
Data for BTK degrader BGB-16673 from phase 1/2
study highlight its potential in both treatment-resistant CLL and
other B-cell malignancies representing high unmet needs
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company that plans to change its name to BeOne Medicines
Ltd., today announced the presentation of new clinical data at the
66th American Society of Hematology (ASH) Annual Meeting and
Exposition, underscoring its leadership in chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL) through continued
clinical success with BRUKINSA® (zanubrutinib) and promising
advancements in its pipeline assets.
“The breadth of data we’re presenting at ASH underscores
BRUKINSA’s role as a best-in-class treatment for CLL and highlights
BeiGene’s leadership in advancing the treatment landscape for
B-cell malignancies,” said Mehrdad Mobasher, M.D., M.P.H., Chief
Medical Officer, Hematology at BeiGene. “BRUKINSA shows tremendous
promise for patients as a monotherapy and as a backbone for
best-in-class combinations. The combination of BRUKINSA and our
investigational BCL2 inhibitor, sonrotoclax, demonstrated
significant potential as a first-line therapy in CLL, with a 99%
overall response rate, best uMRD rate of 92%, and was generally
well-tolerated at a median follow-up of 19.4 months; this
combination is expected to offer better efficacy than a fixed-dose
V-O regimen. Additionally, our investigational BTK degrader could
become a first-in-class treatment option for patients with CLL and
other BTK-driven B-cell malignancies based on the results of data
presented at ASH. BeiGene is primed to shape the future of CLL
treatment and aims to meet the needs of CLL patients globally.”
Long-term follow-up results from the ongoing Phase 3 SEQUOIA
study presented during ASH, which were simultaneously published in
the Journal of Clinical Oncology, reaffirm BRUKINSA’s durable
efficacy and differentiated safety profile across diverse CLL
patient populations, including those with high-risk features.
Additional findings spotlight the promising potential of BeiGene’s
BTK-targeted chimeric degradation activation compound (CDAC),
BGB-16673, which has shown rapid and deep responses in B-cell
malignancies in phase 1/2 clinical trials. BeiGene is also
developing a next-generation BCL2 inhibitor, sonrotoclax, aiming to
improve the safety profile and feasibility of use for this class of
drugs and deliver deeper and more durable responses. Together,
these advancements reflect BeiGene’s comprehensive approach to
addressing the complexities of CLL and its commitment to reshaping
the treatment landscape for B-cell malignancies.
With a median follow-up of 61.2 months, data from the SEQUOIA
study of patients with treatment-naïve CLL/SLL demonstrated that
treatment with BRUKINSA reduced the risk of progression or death by
71% (HR, 0.29; 95% CI, 0.21-0.40; P<.0001*) compared to
bendamustine-rituximab (BR). At 54 months, 80.1% of patients who
received BRUKINSA remained progression-free (95% CI, 74.3, 84.7)
while only 44.6% of patients who received BR remained
progression-free (95% CI, 37.6, 51.3). At 60 months, PFS rates were
75.8% (95% CI, 69.0, 81.3) and 40.1% (95% CI, 32.7, 47.3) for
BRUKINSA and BR, respectively. Notably, for patients in the study
with unmutated IGHV, a prognostic biomarker that indicates a
patient’s CLL may be more aggressive, treatment with BRUKINSA
reduced the risk of progression or death by 79% compared to BR (HR,
0.21; 95% CI, 0.14-0.33; P<.0001*). The safety profile of
BRUKINSA was consistent with the results of prior studies, and no
new safety signals were identified. Grade ≥3 treatment-emergent
adverse events of interest (AEIs) with BRUKINSA and BR included
infection (30.0% and 22.5%, respectively), neutropenia (12.5%;
51.1%), bleeding (7.5%; 1.8%), thrombocytopenia (2.5%; 8.4%), and
anemia (0.8%; 2.6%). Rates of atrial fibrillation were 7.1% with
BRUKINSA and 3.5% with BR. The rate of discontinuation due to AEs
was 20% in the BRUKINSA arm; 13% of patients discontinued BR early
due AEs.(Abstract 3249)
“The long-term follow-up of SEQUOIA confirms the sustained
efficacy of zanubrutinib over chemotherapy, regardless of IGHV
status, in patients with treatment-naïve CLL,” said Mazyar Shadman,
M.D. M.P.H., Associate Professor and Innovators Network Endowed
Chair, Medical Director, Cellular Immunotherapy and the Bezos
Family Immunotherapy Clinic at Fred Hutch Cancer Center. He also
holds the Innovators Network Endowed Chair at Fred Hutch and is
Associate Professor at Fred Hutch and University of Washington.
“Notably, there is a deepening of responses, with a complete
remission/complete remission with incomplete count recovery rate in
the range of 20%, which, based on cross-trial comparison is higher
than a typical BTK inhibitor used as monotherapy. Additionally, the
incidence of adverse events of interest, such as atrial
fibrillation and hypertension, appears comparable to the background
risk of this patient population.”
In addition to BRUKINSA, BeiGene is advancing a robust pipeline
to address the needs of CLL patients, including:
- Sonrotoclax (BCL2 Inhibitor): Presented data from the
Phase 1/1b study (NCT04277637) demonstrated sonrotoclax, in
combination with BRUKINSA, was generally well-tolerated and no
cases of tumor lysis syndrome (TLS) were reported in patients with
treatment-naïve CLL/SLL. Grade ≥3 treatment-emergent adverse events
(TEAEs) occurred in 49.6% of patients, with the most common (≥20%)
being neutropenia (24% in 160mg cohort; 23% in 320mg cohort). With
a median follow-up of 19.4 months (0.4–33.3 months), the
combination achieved a 99% overall response rate (ORR), including
in patients with high-risk features (51% had unmutated IGHV, 20%
had TP53 mutation, and 9% had del(17p)). High and early rates of
undetectable minimal residual disease (uMRD) were seen by week 24
of combination therapy, with responses continuing to deepen with
time through week 48. Best uMRD rate was achieved in 92% of
patients (n=112). At a median follow-up of over a year and a half,
no progression has been observed in the 320 mg dose cohort. These
data support continued evaluation of this combination in the
ongoing registrational Phase 3 fixed-duration CELESTIAL-TNCLL study
(NCT06073821) (Abstract 1012)
- BGB-16673 (BTK CDAC): Data from the Phase 1/2
CaDAnCe-101 CLL study (NCT05006716) demonstrated that treatment
with BGB-16673 was generally well tolerated in this heavily
pretreated population of patients. Promising antitumor activity was
observed in patients with high-risk features, including in patients
with BTK inhibitor-resistant mutations and those previously exposed
to covalent BTK inhibitors, noncovalent BTK inhibitors, and BCL2
inhibitors. No atrial fibrillation was observed in either the
CLL/SLL or WM cohorts.
- From the cohort of CLL/SLL patients, BGB-16673 demonstrated an
ORR of 94% at the 200mg dose. Furthermore, amongst all doses
delivered, 2 patients achieved a complete remission/complete
remission with incomplete count recovery (CR/CRi). Grade ≥3 TEAEs
were reported in 57% of patients. The most common grade ≥3 TEAEs
(≥10%) were neutropenia/neutrophil count decreased (20%) and
pneumonia (10%). (Abstract 885)
- From the cohort of Waldenstr�m's macroglobulinemia patients,
BGB-16673 demonstrated a 93% disease control rate (DCR) and 26%
very good partial response (VGPR). Grade ≥3 TEAEs were reported in
45% of patients. The most common grade ≥3 TEAE (≥20%) was
neutropenia/neutrophil count decreased. (Abstract 860)
For additional information about BeiGene’s presence at ASH 2024,
please visit our meeting hub: congress.beigene.com.
The Company recently announced its intent to change its name to
BeOne Medicines, reaffirming its commitment to develop innovative
medicines to eliminate cancer by partnering with the global
community to serve as many patients as possible.
*P-value was one-sided and descriptive.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is a life-threatening cancer
of adults. It 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.1,2 CLL is the most common type of leukemia in
adults, accounting for about one-third of new cases.2,3
Approximately 20,700 new cases of CLL will be diagnosed in the U.S.
in 2024.3
About Sonrotoclax (BGB-11417)
Sonrotoclax is designed to block the B-cell lymphoma 2 (BCL2)
protein, which helps cancer cells survive. It is part of a group of
drugs called BH3 mimetics, which mimic natural cell death signals.
Studies in the lab and during early drug development have shown
that sonrotoclax is a potent and specific inhibitor of BCL2 with a
short half-life and no accumulation. Sonrotoclax has shown
promising clinical activity across a range of B-cell malignancies,
and more than 1,300 patients have been enrolled to date across the
global development program. The U.S. Food and Drug Administration
(FDA) granted sonrotoclax Fast Track Designation for the treatment
of patients with mantle cell lymphoma (MCL) and Waldenstr�m
macroglobulinemia (WM).
About BGB‑16673
BGB‑16673 is an orally available, brain-penetrating Bruton’s
tyrosine kinase (BTK) targeting chimeric degradation activation
compound (CDAC) designed to promote the degradation, or breakdown,
of both wildtype and mutant forms of BTK, including those that
commonly result in resistance to BTK inhibitors in patients who
experience progressive disease. BGB-16673 is the most advanced BTK
degrader in the clinic, with more than 350 patients treated to date
across the global clinical development program. The U.S. Food and
Drug Administration (FDA) granted Fast Track Designation to
BGB-16673 for the treatment of adult patients with relapsed or
refractory (R/R) chronic lymphocytic leukemia or small lymphocytic
lymphoma (CLL/SLL) who have been previously treated with at least
two prior lines of therapy, including BTK inhibitor (BTKi) and
B-cell lymphoma 2 (BCL2) inhibitor, and adult patients with R/R
mantle cell lymphoma (MCL).
About BRUKINSA® (zanubrutinib)
BRUKINSA is an orally available, 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.
BRUKINSA has the broadest label globally of any BTK inhibitor
and is the only BTK inhibitor to provide the flexibility of once or
twice daily dosing. The global BRUKINSA clinical development
program includes about 6,000 patients enrolled in 30 countries and
regions across more than 35 trials. BRUKINSA is approved in more
than 70 markets, and more than 100,000 patients have been treated
globally.
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.
Hepatotoxicity, Including Drug-Induced Liver Injury
Hepatotoxicity, including severe, life-threatening, and
potentially fatal cases of drug-induced liver injury (DILI), has
occurred in patients treated with Bruton tyrosine kinase
inhibitors, including BRUKINSA.
Evaluate bilirubin and transaminases at baseline and throughout
treatment with BRUKINSA. For patients who develop abnormal liver
tests after BRUKINSA, monitor more frequently for liver test
abnormalities and clinical signs and symptoms of hepatic toxicity.
If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI,
discontinue BRUKINSA.
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, which plans to change its name to BeOne Medicines, 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 nearly
11,000 colleagues spans five continents. To learn more about
BeiGene, please visit www.beigene.com and follow us on LinkedIn, X
(formerly known as Twitter), Facebook and Instagram.
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 leadership in advancing the treatment landscape for
B-cell malignancies and ability to shape the future of CLL
treatment; the success of BeiGene’s BTK degrader in treating
patients; BeiGene’s ability to meet the global needs of CLL
patients; 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.
________________________ 1 National Cancer Institute. Chronic
Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed
November 2024.
https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq. 2
American Cancer Society. What is Chronic Lymphocytic Leukemia?
Updated May 10, 2018. Accessed November 2024.
https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html.
3 American Cancer Society. Key Statistics for Chronic Lymphocytic
Leukemia. Updated July 1, 2024. Accessed November 2024.
https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/key-statistics.html.
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Investor Contact: Liza Heapes +1 857-302-5663
ir@beigene.com
Media Contact: Kim Bencker +1 610-256-8932
media@beigene.com
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