Submission seeks marketing authorization for
first-line use in combination with chemotherapy in advanced
esophageal squamous cell carcinoma
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company focused on developing and commercializing
innovative and affordable oncology medicines to improve treatment
outcomes and access for patients worldwide, today announced that
the Center for Drug Evaluation (CDE) of the China National Medical
Products Administration (NMPA) has accepted a supplemental
biologics license application (sBLA) for tislelizumab in
combination with chemotherapy as first-line treatment in patients
with unresectable locally advanced, recurrent or metastatic
esophageal squamous cell carcinoma (ESCC).
Esophageal cancers are classified based on the type of cells
involved and ESCC is the most common subtype, accounting for more
than 85% of esophageal cancers worldwidei,ii. In China, esophageal
cancer is the fourth leading cause of death due to malignancy and
remains a significant threat to public health with 246,000 new
diagnoses reported in 2015iii.
“Our global clinical development program for tislelizumab
encompasses more than 20 registration-enabling trials and we are
pleased that our robust clinical data for tislelizumab are
contributing to advancing the treatment landscape for solid tumors
in China,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene.
“We look forward to working with NMPA on this submission and to
progressing global regulatory submissions based on the clinically
meaningful overall survival benefit seen in the RATIONALE 306
trial.”
The sBLA is supported by data from an interim analysis of the
RATIONALE 306 (NCT03783442) global clinical trial that enrolled 649
patients from research centers across Asia-Pacific, Europe, and
North America. RATIONALE 306 results were presented as a
late-breaking oral presentation at the 2022 European Society for
Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer
in June.
Tislelizumab is approved by the China NMPA as a treatment for
nine indications, including approval for use in patients with
locally advanced or metastatic ESCC who have disease progression or
are intolerant to first-line standard chemotherapy. Tislelizumab is
not approved for use outside of China.
About Tislelizumab Tislelizumab is a humanized IgG4
anti-PD-1 monoclonal antibody specifically designed to minimize
binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid
the body’s immune cells to detect and fight tumors. In pre-clinical
studies, binding to Fcγ receptors on macrophages has been shown to
compromise the anti-tumor activity of PD-1 antibodies through
activation of antibody-dependent macrophage-mediated killing of T
effector cells.
Tislelizumab is the first investigational medicine from
BeiGene’s immuno-oncology biologics program and is being evaluated
in solid tumor and hematologic malignancies, as monotherapy and in
combination.
The global tislelizumab clinical development program includes
more than 11,000 subjects enrolled to-date in 30 countries and
regions. More information on the tislelizumab development program,
including clinical trials and regulatory submissions, can be found
on the Tislelizumab Fact Sheet in our corporate press kit.
About RATIONALE 306 RATIONALE 306 (NCT03783442) is a
randomized, placebo-controlled, double-blind, global Phase 3 study
to evaluate the efficacy and safety of tislelizumab in combination
with chemotherapy as a first-line treatment in patients with
advanced or metastatic ESCC. The primary endpoint of the trial is
overall survival (OS). Secondary endpoints include progression free
survival, overall response rate, duration of response per RECIST
v1.1, and OS in patients with PD-L1 score ≥ 10%, as well as
health-related quality of life measures and safety.
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 and
medical affairs team of approximately 3,300 colleagues dedicated to
advancing more than 100 clinical trials that have involved more
than 16,000 subjects. Our expansive portfolio is directed
predominantly by our internal colleagues supporting clinical trials
in more than 45 countries and regions. 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. BeiGene currently has
three approved medicines discovered and developed in our own labs:
BTK inhibitor BRUKINSA® in the U.S., China, the European Union,
Great Britain, Canada, Australia, and additional international
markets; and the non-FC-gamma receptor binding anti-PD-1 antibody,
tislelizumab, as well as the 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, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also
plan to address greater areas of unmet need globally through our
other collaborations including with Mirati Therapeutics, Seagen,
and Zymeworks.
In January 2021, BeiGene and Novartis announced a collaboration
granting Novartis rights to co-develop, manufacture, and
commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North
America, Europe, and Japan. Building upon this productive
collaboration, BeiGene and Novartis announced an option,
collaboration, and license agreement in December 2021 for BeiGene’s
TIGIT inhibitor, ociperlimab, that is in Phase 3 development.
Novartis and BeiGene also entered into a strategic commercial
agreement through which BeiGene will promote five approved Novartis
Oncology products across designated regions of China.
About BeiGene BeiGene is a global biotechnology company
that is developing and commercializing innovative and affordable
oncology medicines to improve treatment outcomes and access for far
more 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 8,500 colleagues
spans five continents, with administrative offices in Beijing,
China; Cambridge, U.S.; and Basel, Switzerland. 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 the potential for
tislelizumab to treat patients with advanced or metastatic ESCC,
plans for regulatory approvals for tislelizumab in ESCC, BeiGene's
advancement of anticipated clinical development, regulatory
milestones and commercialization of tislelizumab, 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 of its drug
candidates and achieve and maintain profitability; and the impact
of the COVID-19 pandemic on BeiGene’s clinical development,
regulatory, commercial, manufacturing, 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.
i Wang QL, et al. Clin Epidemiol 2018;10:717–728; ii Huang FL,
Yu SJ. Asian J Surg 2018;41:210–215; iii Guidelines for Diagnosis
and Treatment of Esophageal Cancer of the National Health
Commission of China (2022 Edition)
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version on businesswire.com: https://www.businesswire.com/news/home/20220823005212/en/
Investor: Kevin Mannix +1 240-410-0129 ir@beigene.com
Media: Kathleen Cuca +1 551 222 6790
media@beigene.com
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