Application based on results from global Phase
3 RATIONALE-305 trial demonstrating TEVIMBRA plus chemotherapy
significantly improved overall survival in advanced gastric/GEJ
cancer
Prescription Drug User Fee Act target action
date set for December 2024
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced that the U.S. Food and Drug
Administration (FDA) has accepted a Biologics License Application
(BLA) for TEVIMBRA® (tislelizumab), in combination with
fluoropyrimidine- and platinum-containing chemotherapy, for the
treatment of patients with locally advanced unresectable or
metastatic gastric or gastroesophageal junction (G/GEJ)
adenocarcinoma. The FDA’s action date on the BLA is expected in
December 2024.
“There is an urgent need for new treatment options for gastric
cancer, which is often diagnosed at the advanced or metastatic
stage,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid
Tumors at BeiGene. “In clinical trials, TEVIMBRA has demonstrated
its potential to improve survival for patients with gastric and
gastroesophageal junction cancer. This FDA acceptance brings us one
step closer to delivering on a new treatment option for patients
who often face poor prognoses.”
The filing is based on results from the global RATIONALE-305
trial. The study met its primary endpoint of overall survival 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), demonstrating a 20% reduction in
the risk of death. Additionally, TEVIMBRA plus chemotherapy was
associated with a higher objective response rate (47.3% vs. 40.5%)
and median duration of response (8.6 months vs. 7.2 months)
compared to placebo plus chemotherapy. Median progression-free
survival for TEVIMBRA plus chemotherapy was 6.9 months vs. 6.2
months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]). The safety
profile for TEVIMBRA in combination with chemotherapy was
manageable and in line with the known safety profile of anti-PD-1
antibodies.
Grade ≥3 treatment-related adverse events (TRAEs) occurred in
53.8% of patients in the TEVIMBRA plus chemotherapy arm and 49.8%
of patients in the placebo plus chemotherapy arm. The most common
TRAEs of any grade with an incidence ≥30% were nausea, decreased
appetite, platelet count decreased, neutrophil count decreased,
vomiting, and anaemia.
TEVIMBRA was recently approved by the European Commission for
the treatment of patients with advanced or metastatic esophageal
squamous cell carcinoma (ESCC) after prior chemotherapy. The FDA is
also reviewing a BLA for TEVIMBRA as a first-line treatment for
patients with unresectable, recurrent, locally advanced, or
metastatic ESCC with a target action date in July 2024. A BLA for
the treatment of patients with advanced or metastatic ESCC after
prior chemotherapy is also under review by the FDA.
BeiGene has launched more than 17 potentially
registration-enabling trials with TEVIMBRA, of which 11 Phase 3
randomized trials and 4 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-(L)1 status – both as monotherapy and in
combination with other regimens. More than 900,000 patients have
been prescribed TEVIMBRA globally to date.
About RATIONALE-305 RATIONALE-305 (NCT03777657) is a
randomized, double-blind, placebo-controlled, global Phase 3 that
enrolled 997 patients with advanced unresectable or metastatic
G/GEJ adenocarcinoma. The primary endpoint was OS, with
prespecified hierarchy testing for the PD-L1 high population
followed by the intent-to-treat (ITT) population. Results of the
final analysis of the ITT population were presented as a
late-breaking oral presentation during the European Society for
Medical Oncology (ESMO) Congress 2023.
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. In the U.S., it is estimated there were approximately
27,000 patients diagnosed with gastric cancer and 11,000 deaths
from the disease in 2024.2 The five-year survival rate for gastric
cancer in the U.S. is 36%.3 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).4
About TEVIMBRA® (tislelizumab) Tislelizumab 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 to aid
the body’s immune cells to detect and fight tumors.
About BeiGene BeiGene 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 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 TEVIMBRA’s
potential to improve survival for patients with gastric and
gastroesophageal junction cancer; the ability of TEVIMBRA to be a
treatment option for patients with poor prognoses; future
regulatory approval of TEVIMBRA; TEVIMBRA’s ability to safely
delivery clinically meaningful improvements in survival benefits
and quality of life to cancer patients; BeiGene’s advancement,
anticipated clinical development, regulatory submissions and
commercialization of TEVIMBRA; 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 annual report on Form 10-K, 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. Cancer Facts
& Figures 2024. Atlanta: American Cancer Society; 2024. 3
National Cancer Institute. Surveillance, Epidemiology, and End
Results Program. Cancer stat facts: stomach cancer. Available at
https://seer.cancer.gov/statfacts/html/stomach.html. Accessed
January 22, 2024. 4 American Cancer Society. What Is Stomach
Cancer?
https://www.cancer.org/cancer/types/stomach-cancer/about/what-is-stomach-cancer.html.
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version on businesswire.com: https://www.businesswire.com/news/home/20240227824706/en/
Investor: Liza Heapes +1 857-302-5663 ir@beigene.com
Media: Kyle Blankenship +1 667-351-5176
media@beigene.com
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