European Commission approves TEVIMBRA for
previously treated advanced or metastatic esophageal squamous cell
carcinoma (ESCC)
U.S. FDA accepts Biologics License Application
in first-line advanced ESCC
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced that the European Commission
(EC) has approved TEVIMBRA® (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. Additionally, the U.S. Food and Drug
Administration (FDA) accepted for review a Biologics License
Application (BLA) for tislelizumab as a first-line treatment for
patients with unresectable, recurrent, locally advanced, or
metastatic ESCC.
“We are excited to announce the European Commission approval and
the FDA filing acceptance for tislelizumab, having recently
regained full global rights to this important medicine. These are
significant milestones for people with advanced or metastatic ESCC,
as tislelizumab has been shown to deliver clinically meaningful
survival benefit as monotherapy and in combination with
chemotherapy in patients worldwide,” said Mark Lanasa, M.D., Ph.D.,
Chief Medical Officer, Solid Tumors at BeiGene. “We are proud to
bring this therapy to European patients and potentially to American
patients and will continue to focus on ensuring that we develop
tislelizumab to its full potential to address unmet clinical needs
around the world.”
BeiGene has launched more than 20 potentially
registration-enabling trials with TEVIMBRA, of which 10 Phase 3
randomized trials and four Phase 2 trials have already had positive
readouts. Through these trials, TEVIMBRA has demonstrated its
ability to safely deliver clinically meaningful improvements in
survival benefits and quality of life for hundreds of thousands of
cancer patients across a range of tumor types – in many cases,
regardless of PD-L1 status – both as a monotherapy and in
combination with other regimens. More than 750,000 patients have
been prescribed TEVIMBRA to-date.
“TEVIMBRA is the cornerstone of BeiGene’s solid tumor portfolio.
We believe having full control of the development and
commercialization of TEVIMBRA will allow us to rapidly accelerate
our plans and reach more patients worldwide,” said Josh Neiman,
Chief Commercial Officer for North America and Europe at BeiGene.
“We look forward to bringing TEVIMBRA to people living with
advanced or metastatic ESCC, an aggressive disease with limited
treatment options.”
TEVIMBRA Receives European Commission Approval for the
Treatment of Advanced or Metastatic ESCC
The EC approval follows the positive opinion of the Committee
for Medicinal Products for Human Use and is based on positive
results from BeiGene’s RATIONALE 302 study.
“The global RATIONALE 302 trial demonstrated the anti-PD-1
antibody tislelizumab prolonged the survival of patients with
locally advanced or metastatic ESCC who had received prior systemic
treatment, with no new safety signals identified,” said Prof.
Florian Lordick, Director and Professor of Oncology of the
University Cancer Center Leipzig, Germany. “The approval of
tislelizumab in Europe is a noteworthy moment for patients, their
caregivers and their physicians, due to the existing unmet need for
new treatment options.”
RATIONALE 302 is a global, randomized, open-label, Phase 3 study
(NCT03430843) designed to investigate the efficacy and safety of
TEVIMBRA 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 Europe, Asia and North
America.
RATIONALE 302 met its primary endpoint in the intention-to-treat
population with a statistically significant and clinically
meaningful survival benefit for TEVIMBRA compared with chemotherapy
(HR 0.70 [95% CI: 0.57 - 0.85]; one-sided P=0.0001; median overall
survival 8.6 vs 6.3 months). The safety profile for TEVIMBRA was
consistent with previous trials.i The marketing authorization
application included safety data for 1,972 patients who received
TEVIMBRA monotherapy across seven clinical trials.
U.S. FDA Accepts Biologics License Application in First-Line
Advanced ESCC
The FDA has assigned a target action date in the second half of
2024, under the Prescription Drug User Fee Act. The FDA application
is supported by previously announced results from RATIONALE 306
(NCT03783442), a randomized, placebo-controlled, double-blind,
global Phase 3 trial evaluating the efficacy and safety of
tislelizumab in combination with chemotherapy as a first-line
treatment in patients with advanced or metastatic ESCC.
The FDA also granted tislelizumab Orphan Drug Designation (ODD)
for the treatment of previously untreated advanced or metastatic
ESCC. The FDA’s ODD is granted to investigational therapies
intended for the treatment, diagnosis or prevention of rare
diseases or disorders that affect fewer than 200,000 people in the
U.S.ii
About ESCC 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.iii EC is a rapidly fatal disease, and more
than two-thirds of the patients have advanced or metastatic disease
at the time of diagnosis, with a median survival of eight to 10
months and an expected five-year survival rate of less than five
percent.iv
About TEVIMBRA (tislelizumab) TEVIMBRA 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.
TEVIMBRA is currently under review by the U.S. Food and Drug
Administration (FDA) and received approval by the European
Commission (EC) for advanced or metastatic esophageal squamous cell
carcinoma (ESCC) after prior chemotherapy. The EMA is reviewing a
marketing authorization application for TEVIMBRA 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 TEVIMBRA are also under review by
authorities in the U.K., Australia, China, New Zealand, Brazil,
Korea, Switzerland, Israel and Indonesia. Tislelizumab is approved
as a treatment in 11 indications in China and is the leading PD-1
inhibitor in the country.
The tislelizumab development program 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 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 and X (formerly known as
Twitter).
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 ability
to develop tislelizumab to its full potential to address unmet
clinical needs around the world; BeiGene’s ability to accelerate
plans and reach more patients worldwide after regaining rights to
develop and commercialize TEVIMBRA; the future development,
regulatory filing, approval and commercialization 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, commercialization, 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
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 U.S. Food & Drug Administration.
Rare Diseases at FDA.
https://www.fda.gov/patients/rare-diseases-fda. iii 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. iv
Parkin, 1999; Lin M, 2016; Drahos J, 2013.
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Investor: Liza Heapes +1 857-302-5663 ir@beigene.com
Media: U.S. Media Kyle Blankenship +1 667-351-5176
media@beigene.com
EU Media Maryline Iva +41 61 685 2090
media@beigene.com
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