New indications based on two Phase 3 studies
demonstrating statistically significant overall survival benefit
for patients treated with TEVIMBRA in combination with
chemotherapy
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company that intends to change its name to BeOne
Medicines, today announced that the European Commission has
approved TEVIMBRA® (tislelizumab) in combination with chemotherapy
for the first-line treatment of esophageal squamous cell carcinoma
(ESCC) and gastric or gastroesophageal junction (G/GEJ)
adenocarcinoma.
“Patients diagnosed with advanced gastric and esophageal cancers
confront median survival times measured in months, not
years—highlighting the urgent need for more effective treatment
options,” said Prof. Florian Lordick, Director and Professor of
Oncology of the University Cancer Center Leipzig, Germany. “The
compelling data from the RATIONALE-305 and 306 trials underscore
the unique clinical profile of tislelizumab and its potential to
deliver meaningful improvements in outcomes for eligible patients,
offering new hope where it’s needed most.”
In ESCC, the expanded indication is for TEVIMBRA in combination
with platinum-based chemotherapy for the first-line treatment of
adult patients with unresectable, locally advanced or metastatic
cancer whose tumors express PD-L1 with a tumor area positivity
(TAP) score ≥ 5%. In G/GEJ adenocarcinoma, the expanded indication
is for TEVIMBRA in combination with platinum- and
fluoropyrimidine-based chemotherapy for the first-line treatment of
adult patients with HER2-negative locally advanced unresectable or
metastatic cancer whose tumors express PD-L1 with a TAP score ≥
5%.
“As the cornerstone of our solid tumor portfolio, TEVIMBRA is
central to BeiGene’s commitment to delivering innovative treatments
to as many people living with cancer as possible, with more than
1.3 million patients already treated with the medicine worldwide,"
said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors
at BeiGene. "In just over a year, we have achieved approvals in the
European Union across six indications, and we look forward to
working to ensure that patients across Europe have rapid and broad
access to TEVIMBRA.”
In first-line ESCC, the extension of indication application was
based on results from BeiGene’s RATIONALE-306 (NCT03783442), a
randomized, placebo-controlled, double-blind, global Phase 3 study
to evaluate the efficacy and safety of TEVIMBRA in combination with
chemotherapy as a first-line treatment in patients with
unresectable, locally advanced recurrent or metastatic ESCC. The
study enrolled 649 patients at research centers across Europe,
North America and Asia-Pacific. The study met its primary endpoint,
with first-line TEVIMBRA in combination with chemotherapy resulting
in statistically significant and clinically meaningful OS benefit
compared with placebo plus chemotherapy in the intent-to-treat
population. The median OS was 17.2 months for TEVIMBRA with
chemotherapy versus 10.6 months for placebo plus chemotherapy (HR:
0.66 [95% CI, 0.54-0.80, 1-sided p-value of < 0.0001]), a 34%
reduction in the risk of death. Three-year OS in the PD-L1 ≥ 5%
population was also substantially improved in favor of the TEVIMBRA
arm (median 19.1 versus 10.0 months, respectively; HR: 0.62 [95%
CI, 0.49-0.79]), demonstrating a 38% reduction in the risk of
death.
The extension of indication application for first-line G/GEJ
cancer was based on results from BeiGene’s RATIONALE-305
(NCT03777657), a randomized, double-blind, placebo-controlled,
global Phase 3 trial to evaluate the efficacy and safety of
TEVIMBRA in combination with chemotherapy as a first-line treatment
for patients with advanced unresectable or metastatic G/GEJ cancer.
The study enrolled 997 patients at research centers across Europe,
North America and Asia-Pacific. The study met its primary endpoint
and demonstrated a statistically significant and clinically
meaningful overall survival (OS) benefit with a median OS of 15.0
months for patients treated with TEVIMBRA in combination with
investigator’s choice of chemotherapy compared to 12.9 months for
patients treated with placebo plus chemotherapy (n=997; HR: 0.80
[95% CI: 0.70, 0.92]; P=0.0011), resulting in a 20% reduction in
the risk of death. In the PD-L1 ≥ 5% population, the median OS was
16.4 months for TEVIMBRA plus chemotherapy compared to 12.8 months
for the placebo arm (HR: 0.71 [95% CI, 0.58-0.86]), which
represents a 29% reduction in the risk of death.
The safety data in the applications included more than 2,800
patients who received TEVIMBRA as either monotherapy (1,534) or in
combination with chemotherapy (1,319) at the approved dosing
regimen. The most common Grade 3 or 4 adverse reactions (≥ 2%) for
TEVIMBRA given in combination with chemotherapy were neutropenia,
thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia,
pneumonia, decreased appetite, rash, lymphopenia, alanine
aminotransferase increased, aspartate aminotransferase increased,
diarrhea, pneumonitis, and hepatitis.
TEVIMBRA is also approved in the EU for eligible patients with
unresectable, locally advanced or metastatic ESCC after prior
platinum-based chemotherapy and for three NSCLC indications
covering both the first- and second-line settings.
The Company recently announced its intent to change its name to
BeOne Medicines Ltd., reaffirming its commitment to develop
innovative medicines to eliminate cancer by partnering with the
global community to serve as many patients as possible.
About Gastric and Gastroesophageal Junction (G/GEJ)
Adenocarcinoma
Gastric (stomach) cancer is the fifth most common cancer
worldwide and the fifth highest leading cause of cancer mortality.1
Nearly 1 million new patients were diagnosed with gastric cancer in
2022, and 660,000 deaths were reported globally. Gastroesophageal
junction adenocarcinoma occurs at the area where the esophagus
joins the stomach, which is just beneath the diaphragm (the thin
sheet of breathing muscle under the lungs).2
About Esophageal Squamous Cell Carcinoma (ESCC)
Globally, esophageal cancer is the sixth most common cause of
cancer-related deaths, and ESCC is the most common histologic
subtype, accounting for nearly 90% of esophageal cancers. An
estimated 957,000 new esophageal cancer cases are projected in
2040, an increase of nearly 60% from 2020, underscoring the need
for additional effective treatments.3 Esophageal cancer is a
rapidly fatal disease, and more than two-thirds of patients have
advanced or metastatic disease at the time of diagnosis, with an
expected five-year survival rate of less than 6% for those with
distant metastases.4
About TEVIMBRA (Tislelizumab)
TEVIMBRA 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 the body’s immune cells detect and fight
tumors.
TEVIMBRA is the foundational asset of BeiGene’s solid tumor
portfolio and has shown potential across multiple tumor types and
disease settings. The global TEVIMBRA clinical development program
includes almost 14,000 patients enrolled to date in 34 counties and
regions across 66 trials, including 20 registration-enabling
studies. TEVIMBRA is approved in 42 countries, and more than 1.3
million patients have been treated globally.
Important Safety Information
The current European Summary of Product Characteristics (SmPC)
for TEVIMBRA is available from the European Medicines Agency.
This information is intended for a global investor and media
audience. Product indications vary by region.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines Ltd.,
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 nearly
11,000 colleagues spans five continents. To learn more about
BeiGene, please visit www.beigene.com and follow us on LinkedIn, X
(formerly known as Twitter), Facebook and Instagram.
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
tislelizumab’s potential to deliver meaningful improvements in
outcomes for eligible patients; BeiGene’s ability to provide rapid
and broad access to TEVIMBRA to patients across Europe; 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.
To access BeiGene media resources, please visit our News
& Media site.
___________________ 1 Ferlay J, Ervik M, Lam F, Laversanne M,
Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F
(2020). Global Cancer Observatory: Cancer Today. Lyon, France:
International Agency for Research on Cancer. Available from:
https://gco.iarc.who.int/today. Accessed February 9, 2024. 2
American Cancer Society. What Is Stomach Cancer?
https://www.cancer.org/cancer/types/stomach-cancer/about/what-is-stomach-cancer.html.
3 Morgan E, et al. 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. 2022 Sep;163(3):649-658.e2. doi:
10.1053/j.gastro.2022.05.054. Epub 2022 Jun 4. PMID: 35671803. 4
National Cancer Institute. Cancer stat facts: esophageal cancer.
https://seer.cancer.gov/statfacts/html/esoph.html.
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version on businesswire.com: https://www.businesswire.com/news/home/20241127759978/en/
Investor Contact: Liza Heapes +1 857-302-5663
ir@beigene.com
Media Contact: Kim Bencker +1 610-256-8932
media@beigene.com
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