BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global
biotechnology company focused on developing and commercializing
innovative medicines worldwide, today announced that clinical
results and subgroup analyses from the Company’s robust lung cancer
program will be presented at the European Society for Medical
Oncology (ESMO) Congress 2021.
“We continue to make meaningful progress with our deep
immuno-oncology portfolio, including our lung cancer program of
seven Phase 3 trials in NSCLC. Driven by growing clinical insights,
we are working to accelerate the development of tislelizumab in
novel combinations in lung cancer, including with our internally
discovered potent investigational anti-TIGIT antibody ociperlimab
and therapeutic agents from collaborations, such as sitravatinib,”
commented Yong (Ben) Ben, M.D., Chief Medical Officer,
Immuno-Oncology at BeiGene. “In addition, our scientists are
exploring new modalities for potential combinations with
tislelizumab in lung cancer and other solid tumors, and with the
ongoing Novartis collaboration, tislelizumab can be leveraged with
their oncology pipeline for more combination opportunities. We plan
to work to realize the therapeutic potential of this differentiated
checkpoint inhibitor through combinations in various tumor types
for patients worldwide.”
To learn more about BeiGene’s research and development and
activities around ESMO, please visit
https://beigenemedical.eu/.
Broad Lung Cancer Program Focused on Tislelizumab Combination
Treatments
BeiGene is pursuing diverse mechanisms of action in combination
with tislelizumab to complement targeting of the PD-1 pathway for
potentially improved clinical outcomes or to overcome resistance
associated with disease progression.
In NSCLC, many patients who have achieved a response to
front-line anti-PD-1 antibody treatment eventually relapse due to
resistance. Through its collaboration with Mirati Therapeutics,
BeiGene is investigating the combination of tislelizumab and
sitravatinib, a spectrum-selective tyrosine kinase inhibitor
potentially capable of reversing immunosuppressive tumor
microenvironment to overcome immune resistance. BeiGene is
conducting a Phase 3 trial of this novel combination in NSCLC, and
clinical results from an ongoing Phase 1b trial in patients with
metastatic NSCLC, both naïve and refractory or resistance to
anti-PD-(L)1 treatment, will be presented at ESMO Congress
2021.
Another novel combination of tislelizumab that BeiGene is
investigating in lung cancer is with ociperlimab, a potent,
Fc-intact investigational anti-TIGIT-antibody in Phase 3 clinical
development. TIGIT is a co-inhibitory immune checkpoint receptor
expressed on multiple immune cells and has recently emerged as a
new therapeutic target that in collaboration with PD-1 has the
potential to further suppress antitumor immune response.
Tislelizumab’s broad combination portfolio in lung cancer also
includes PI3K-delta inhibitor BGB-10188, anti-TIM-3 antibody
BGB-A425, and chemotherapy.
Growing NSCLC Program Driven by Scientific Excellence and
Clinical Insights
To address the prevalence of NSCLC worldwide and the clinical
unmet need despite treatment progress in recent years, BeiGene is
currently evaluating tislelizumab in a comprehensive NSCLC program
of more than 10 clinical trials covering disease settings from
early to late lines.
To gain key insights into how different patient characteristics
can impact treatment outcomes, BeiGene’s immuno-oncology team
reviews clinical results from NSCLC trials by geography, disease
stage, smoking status, and using biomarkers.
Subgroup analyses on BeiGene’s RATIONALE 307 trial recently
presented at the 2021 World Conference on Lung Cancer (WCLC) showed
that tislelizumab in combination with chemotherapy provided
consistent survival benefits in treatment-naïve patients with
squamous NSCLC, regardless of PD-L1 expression, blood tumor
mutation burden (TMB), tissue TMB, and disease stage (IIIB or
IV).
At the ESMO Congress 2021, additional analyses on smokers vs.
nonsmokers in the two Phase 3 clinical trials in first-line NSCLC,
RATIONALE 304 and RATIONALE 307 will be reported.
In addition, the Company is exploring tislelizumab’s potential
as an early treatment option, with an ongoing global Phase 3 trial
RATIONALE 315 in neoadjuvant or adjuvant settings.
BeiGene’s ePoster Presentations at ESMO Congress 2021
Abstract #
Title
Lead Author
3649
Sitravatinib + tislelizumab in patients with anti-PD-(L)1
refractory/resistant metastatic NSCLC
Bo Gao, M.D., Ph.D. Blacktown Cancer and Hematology Centre
(Australia)
3457
Sitravatinib + tislelizumab in patients with metastatic
NSCLC
Qing Zhou, M.D., Ph.D. Guangdong Lung Cancer Institute
(China)
2562
Effects of tislelizumab monotherapy on health-related quality of
life in patients with previously treated unresectable HCC
Zhenggang Ren, M.D., Ph.D. Zhongshan Hospital (China)
3786
RATIONALE 304: Tislelizumab plus chemotherapy vs chemotherapy
alone as first-line treatment for non-squamous NSCLC in patients
who are smokers vs non-smokers
Shun Lu, M.D. Shanghai Lung Cancer Center (China)
4053
Tislelizumab plus chemotherapy vs chemotherapy alone as
first-line treatment for advanced squamous NSCLC in patients who
were smokers vs non-smokers
Xinmin Yu, M.D. Zhejiang Cancer Hospital (China)
1587
Association between use of antibiotics and clinical outcomes
with tislelizumab monotherapy
Zhenggang Ren, M.D., Ph.D. Zhongshan Hospital (China)
BeiGene Oncology
BeiGene is committed to advancing best and first-in-class
clinical candidates internally or with like-minded partners to
develop impactful and affordable medicines for patients across the
globe. We have a growing R&D team of approximately 2,300
colleagues dedicated to advancing more than 90 clinical trials
involving more than 13,000 patients and healthy volunteers. Our
expansive portfolio is directed by a predominantly internalized
clinical development team supporting trials in more than 40
countries. Hematology-oncology and solid tumor targeted therapies
and immuno-oncology are key focus areas for the Company, with both
mono- and combination therapies prioritized in our research and
development. We currently market three medicines discovered and
developed in our labs: BTK inhibitor BRUKINSA in the United States,
China, Canada, and additional international markets; and
non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and
PARP inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialize a range of oncology medicines in China licensed from
Amgen and Bristol Myers Squibb. We also plan to address greater
areas of unmet need globally through our collaborations including
with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen,
and Zymeworks. BeiGene has also entered into a collaboration with
Novartis granting Novartis rights to develop, manufacture, and
commercialize tislelizumab in North America, Europe, and Japan.
About BeiGene
BeiGene is a global, science-driven biotechnology company
focused on developing innovative and affordable medicines to
improve treatment outcomes and access for patients worldwide. With
a broad portfolio of more than 40 clinical candidates, we are
expediting development of our diverse pipeline of novel
therapeutics through our own capabilities and collaborations. We
are committed to radically improving access to medicines for two
billion more people by 2030. BeiGene has a growing global team of
over 7,000 colleagues across five continents. To learn more about
BeiGene, please visit www.beigene.com and follow us on
Twitter at @BeiGeneGlobal.
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 plan for the advancement, and anticipated clinical
development, regulatory milestones and commercialization of
tislelizumab and other drug candidates, and BeiGene’s plans,
commitments, aspirations, and goals under the headings “BeiGene
Oncology” and “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 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 and
commercialization of its drug candidates and achieve and maintain
profitability; the impact of the COVID-19 pandemic on the BeiGene’s
clinical development, regulatory, commercial, and other operations,
as well as 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.
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BeiGene
Investor Contact Gabrielle Zhou +86 10-5895-8058 or +1
857-302-5189 ir@beigene.com
Media Contact Liza Heapes or Vivian Ni +1 857-302-5663 or
+1 857-302-7596 media@beigen.com
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