Multiple presentations to showcase the
efficacy and safety of BRUKINSA® across a range of B-cell
malignancies
Company to present three-year data from
RATIONALE-306 study of TEVIMBRA® in advanced or metastatic
esophageal squamous cell carcinoma (ESCC)
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced it will share research outcomes
from its broad hematology and solid tumor portfolio at the American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May
31 - June 4, 2024.
“Our presentations at this year’s ASCO highlight the strength of
our growing oncology portfolio and our commitment to developing
treatments that address the unmet needs of patients with B-cell
malignancies and solid tumors,” Mehrdad Mobasher, M.D., M.P.H.,
Chief Medical Officer, Hematology at BeiGene. “The exciting data we
will share during ASCO showcase BRUKINSA’s uniquely differentiated
clinical profile and add to the growing body of evidence supporting
its role across the blood cancer treatment paradigm.”
BeiGene will share new data for BRUKINSA (zanubrutinib), which
add to the robust efficacy and safety evidence differentiating it
within the BTK class. Key highlights include:
- A network meta-analysis comparing the efficacy of BRUKINSA vs
acalabrutinib in patients with relapsed/refractory chronic
lymphocytic leukemia (CLL); and
- A post-hoc analysis from the Phase 3 ALPINE study of BRUKINSA
vs ibrutinib evaluating the risk of developing hypertension based
on the initiation and adjustment of antihypertensive
medications.
Reflecting BeiGene’s growing solid tumor development program,
TEVIMBRA (tislelizumab-jsgr) will be the subject of multiple
presentations – as a monotherapy, in combination with chemotherapy
agents, and as part of immunotherapy regimens across a range of
tumor types. Key highlights include:
- New data from the Phase 3 RATIONALE-306 study evaluating
TEVIMBRA plus chemotherapy in patients with advanced or metastatic
esophageal squamous cell carcinoma (ESCC); and
- Initial data from a first-in-human study evaluating HPK1
inhibitor BGB-15025 alone and in combination with TEVIMBRA.
“Our data at ASCO are a testament to the potential versatility
of TEVIMBRA across a range of tumor types, and we are excited by
the momentum of this critical pillar of our solid tumor development
program,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer,
Solid Tumors at BeiGene. “During the meeting, we look forward to
sharing a new analysis from our RATIONALE-306 study, which will
provide insights into the three-year efficacy and safety of
TEVIMBRA as a first-line treatment for ESCC.”
BeiGene Presentations During ASCO 2024
Abstract Title
Abstract #
Presentation Details
Lead Author
Hematology
Comparative efficacy of Bruton tyrosine
kinase inhibitors in the treatment of relapsed/refractory chronic
lymphocytic leukemia: a network meta-analysis (NMA)
7048
Session Type and Title:
Poster Session – Hematologic Malignancies—Lymphoma and Chronic
Lymphocytic Leukemia
Session Date and Time:
June 3 at 9:00 AM-12:00 PM CDT
M. Shadman
Real-world treatment patterns and outcomes
of zanubrutinib in chronic lymphocytic leukemia and small
lymphocytic lymphoma (CLL/SLL)
11158
Session Type and Title:
Poster Session – Quality Care/Health Services Research
Session Date and Time:
June 3 at 9:00 AM-12:00 PM CDT
M. Krackeler
Risk of hypertension in patients with
CLL/SLL who participated in ALPINE: a post hoc analysis
N/A
Online
D. Ramirez
Risk of new-onset hypertension in newly
diagnosed chronic lymphocytic leukemia (CLL) patients (pts) treated
with Bruton tyrosine kinase inhibitors (BTKi): A real-world data
study using the Symphony Health Solution database
N/A
Online
T. Kou
Real-world treatment switching and
sequencing to next line of therapy of zanubrutinib, acalabrutinib,
and ibrutinib in CLL/SLL
N/A
Online
J. Pinilla-Ibarz
Real-world adherence and healthcare
resource utilization of Bruton tyrosine kinase inhibitors (BTKi) in
mantle cell lymphoma
N/A
Online
B. Shah
Comparison of zanubrutinib (zanu) and
acalabrutinib (acala) in B-cell malignancies: an adverse event
(AE)-based analysis
N/A
Online
T. Munir
Clinical and financial burden of mental
health (MH) conditions in patients (pts) with low-grade non-Hodgkin
lymphoma (LG-NHL)
7072
Session Type and Title:
Poster Session – Hematologic Malignancies—Lymphoma and Chronic
Lymphocytic Leukemia
Session Date and Time:
June 3 at 9:00 AM-12:00 PM CDT
K. Yang
Real-world evaluation of treatment
pattern, time to next treatment (TTNT), healthcare resource
utilization (HCRU), and cost of care in follicular lymphoma
(FL)
N/A
Online
S. Gaballa
Real-world Bruton tyrosine kinase
inhibitor (BTKi) treatment patterns and outcomes among patients
with chronic lymphocytic leukemia or small lymphocytic lymphoma
(CLL/SLL) in US community oncology practices
N/A
Online
J. Hou
BGB-11417-203, an ongoing, phase 2 study
of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in
patients with Waldenstr�m macroglobulinemia
TPS7090
Session Type and Title:
Poster Session – Hematologic Malignancies—Lymphoma and Chronic
Lymphocytic Leukemia
Session Date and Time:
June 3 at 9:00 AM-12:00 PM CDT
H. Lee
CELESTIAL-TNCLL: An ongoing, open-label,
multiregional, phase 3 study of sonrotoclax (BGB-11417) +
zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN)
CLL
TPS7087
Session Type and Title:
Poster Session – Hematologic Malignancies—Lymphoma and Chronic
Lymphocytic Leukemia
Session Date and Time:
June 3 at 9:00 AM-12:00 PM CDT
M. Shadman
Solid Tumor/IO
Global, randomized, phase III study of
tislelizumab plus chemotherapy versus placebo plus chemotherapy as
first-line treatment for advanced/metastatic esophageal squamous
cell carcinoma (RATIONALE-306 update): minimum 3-year survival
follow-up
4032
Session Type and Title:
Poster Session – Gastrointestinal Cancer—Gastroesophageal,
Pancreatic, and Hepatobiliary
Session Date and Time:
June 1 at 1:30-4:30 PM CDT
H. Yoon
BGB-A317-212: A multicenter, open-label,
phase II study to evaluate the efficacy and safety of tislelizumab
in combination with lenvatinib in patients with selected solid
tumors
2610
Session Type and Title:
Poster Session – Developmental Therapeutics—Immunotherapy
Session Date and Time:
June 1 at 9:00 AM-12:00 PM CDT
L. Yufei
Preoperative (neoadjuvant) therapy with
tislelizumab for locally advanced colorectal cancer with high
microsatellite instability or deficient mismatch repair: an
open-label, single-arm, multicenter phase II study
3599
Session Type and Title:
Poster Session – Gastrointestinal Cancer—Colorectal and Anal
Session Date and Time:
June 1 at 1:30-4:30 PM CDT
K. Ding
Tislelizumab First-Line (1L)
Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy
on PRO-Based Symptom Endpoints Adjusting for Informative Missing
Data Bias: Results from RATIONALE 305
2605
Session Type and Title:
Poster Session – Developmental Therapeutics—Immunotherapy
Session Date and Time:
June 1 at 9:00 AM-12:00 PM CDT
D. Serrano
A first‑in‑human phase 1a dose‑escalation
study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in
combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients
(pts) with advanced solid tumors
2585
Session Type and Title:
Poster Session – Developmental Therapeutics—Immunotherapy
Session Date and Time:
June 1 at 9:00 AM-12:00 PM CDT
S. Deva
Long-term pooled safety analysis of
tislelizumab as monotherapy or in combination with chemotherapy in
patients with advanced cancers.
N/A
Online
C. Zhou
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.
Please see full U.S. Prescribing Information for BRUKINSA®
(zanubrutinib), including U.S. Patient Information or visit
www.brukinsa.com.
About TEVIMBRA® (tislelizumab-jsgr) Tislelizumab is a
uniquely designed humanized immunoglobulin G4 (IgG4)
anti-programmed cell death protein 1 (PD-1) monoclonal antibody
with high affinity and binding specificity against PD-1. It is
designed to minimize binding to Fc-gamma (Fcγ) receptors on
macrophages, helping to aid the body’s immune cells to detect and
fight tumors.
Please see full U.S. Prescribing Information for TEVIMBRA®
(tislelizumab-jsgr), including Medication Guide.
About Sonrotoclax (BGB11417) Sonrotoclax is an
investigational small molecule B-cell lymphoma 2 (BCL2) inhibitor.
It belongs to a class of BCL2 homology 3 (BH3) mimetics, and
preclinical and IND-enabling studies have demonstrated potent
activity and high selectivity of sonrotoclax against the
antiapoptotic protein BCL2. Sonrotoclax is more potent and
selective for BCL2 relative to BCLxL than venetoclax and shows the
potential to overcome common BCL2 resistance mutations.
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, 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 the strength and
future growth of BeiGene’s oncology portfolio; BeiGene’s ability to
develop treatments that address the unmet needs of patients with
B-cell malignancies and solid tumors; the versatility of
tislelizumab across tumor types; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240424524928/en/
Investor Contact: Liza Heapes +1 857-302-5663
ir@beigene.com
Media Contact: Kyle Blankenship +1 667-351-5176
media@beigene.com
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