BeiGene (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has issued a positive opinion recommending approval
for tislelizumab as monotherapy for the treatment of adult patients
with unresectable, locally advanced or metastatic esophageal
squamous cell carcinoma (ESCC) after prior platinum-based
chemotherapy.
“Tislelizumab is the first medicine to come from BeiGene’s
immuno-oncology research program and our team partnered with
patients, caregivers, and clinical researchers across the world to
generate the evidence supporting this CHMP recommendation,” said
Lai Wang, Ph.D., Global Head of R&D at BeiGene. “We continue to
make progress in our mission to bring the highest quality therapies
to more people around the world and look forward to working with
Novartis and health authorities on regulatory filings for
tislelizumab.”
The Marketing Authorization Application (MAA) for ESCC is based
on results from BeiGene’s RATIONALE 302, a global, randomized,
open-label, Phase 3 study (NCT03430843) to investigate the efficacy
and safety of tislelizumab when compared with investigator’s choice
chemotherapy as a second-line treatment for patients with
unresectable, locally advanced or metastatic ESCC. The study
enrolled 513 patients from 132 research sites in 11 countries in
Asia, Europe, and North America. The study met its primary endpoint
with a statistically significant and clinically meaningful survival
benefit for tislelizumab compared with chemotherapy (HR 0.70 [95%CI
0.57 - 0.85]; one-sided P=.0001; median overall survival 8.6 vs 6.3
months). The safety profile for tislelizumab was consistent with
previous trials.i The MAA included safety data for 1,972 patients
who received tislelizumab monotherapy in seven clinical trials.
Tislelizumab is not currently authorized for use in Europe.
About ESCCii Globally, esophageal cancer (EC) is the
sixth most common cause of cancer-related deaths and ESCC is the
most common histologic subtype, accounting for more than 85% of
ECs. An estimated 957,000 new EC cases are projected in 2040, an
increase of nearly 60% from 2020 that underscores the need for
additional effective treatments.
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.
In 2021, BeiGene and Novartis announced a collaboration
agreement to jointly develop tislelizumab in the United States,
Canada, Mexico, member countries of the European Union, United
Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and
Japan. Under the agreement Novartis is responsible for regulatory
submission and has the right to commercialize in these licensed
countries following regulatory approval.
The EMA is reviewing a MAA for tislelizumab as a treatment for
locally advanced or metastatic non-small cell lung cancer (NSCLC)
after prior chemotherapy, and in combination with chemotherapy for
previously untreated locally advanced or metastatic NSCLC.
Regulatory submissions for tislelizumab are also under review by
authorities in the U.S., U.K., Australia, China, New Zealand,
Brazil, Korea, Switzerland and Indonesia.
More than 12,000 patients from across the world have
participated in the tislelizumab development program that
encompasses 21 registration-enabling clinical trials in more than
30 countries and regions. To date, BeiGene has announced positive
readouts from 10 Phase 3 pivotal studies across multiple tumor
types and disease settings such as NSCLC, Small Cell Lung Cancer,
Gastric Cancer, ESCC, Hepatocellular Cancer, and Nasopharyngeal
Cancer. More information on the clinical trial program for
tislelizumab can be found at:
https://www.beigene.com/en-us/science-and-product-portfolio/pipeline.
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 9,400 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 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 progress
to expand the highest quality therapies to more people around the
world; the future development, regulatory filing and approval of
tislelizumab; 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, 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; 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 Shen, L., Kato, K., Kim, S. B., Ajani, J. A., Zhao, K., He,
Z., ... & Van Cutsem, E. (2022). Tislelizumab versus
chemotherapy as second-line treatment for advanced or metastatic
esophageal squamous cell carcinoma (RATIONALE-302): A randomized
phase III study. Journal of Clinical Oncology, 40(26), 3065-3076.
DOI: 10.1200/JCO.21.01926 ii Morgan, E., Soerjomataram, I., Rumgay,
H., Coleman, H. G., Thrift, A. P., Vignat, J., ... & Arnold, M.
(2022). The global landscape of esophageal squamous cell carcinoma
and esophageal adenocarcinoma incidence and mortality in 2020 and
projections to 2040: new estimates from GLOBOCAN 2020.
Gastroenterology, 163(3), 649-658.
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version on businesswire.com: https://www.businesswire.com/news/home/20230721581393/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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