Comprehensive development program, including
three Phase 3 clinical trials, demonstrated benefit of tislelizumab
for patients with treatment-naïve and relapsed NSCLC
Decision represents tislelizumab’s second
approval in the region
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced that the European Commission (EC)
has approved tislelizumab as a treatment for non-small cell lung
cancer (NSCLC) across three indications, including first- and
second-line use.
“Tislelizumab is foundational for BeiGene’s solid tumor
portfolio and has demonstrated its potential across multiple tumor
types, including NSCLC, in which there remains a significant unmet
need at all stages of the disease,” said Mark Lanasa, M.D., Ph.D.,
Chief Medical Officer, Solid Tumors at BeiGene. “Today’s EC
authorization marks the second in the region for tislelizumab, with
both NSCLC and locally advanced or metastatic esophageal squamous
cell carcinoma now approved in the European Union. Second-line use
in ESCC was also approved just weeks ago by the U.S. Food and Drug
Administration, putting us well on our way to fulfilling our
commitment to bring this innovative therapy to many more patients
around the world.”
The approved indications for tislelizumab are:
- In combination with carboplatin and either paclitaxel or
nab-paclitaxel for the first-line treatment of adult patients with
squamous NSCLC who have locally advanced NSCLC and are not
candidates for surgical resection or platinum-based chemoradiation,
or metastatic NSCLC.
- In combination with pemetrexed and platinum-containing
chemotherapy for the first-line treatment of adult patients with
non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of
tumor cells with no EGFR or ALK positive mutations and who have
locally advanced NSCLC and are not candidates for surgical
resection or platinum-based chemoradiation, or metastatic
NSCLC.
- As monotherapy for the treatment of adult patients with locally
advanced or metastatic NSCLC after prior platinum-based therapy.
Patients with EGFR mutant or ALK positive NSCLC should also have
received targeted therapies before receiving tislelizumab.
“Non-small cell lung cancer remains one of the most common and
deadly cancers in Europe, with 50% of patients diagnosed already
progressed to advanced stages, making it difficult to treat,” said
Luis Paz-Ares, M.D., Ph.D., Head of the Medical Oncology Service at
the Hospital Universitario 12 de Octubre, Madrid. “Across three
Phase 3 studies, tislelizumab has been shown to improve outcomes
for patients with certain types of NSCLC, providing a new option
for those facing the disease.”
Tislelizumab was approved for these NSCLC indications under the
brand name TIZVENI®. BeiGene plans to combine the NSCLC indications
with the second-line ESCC indication under the brand name
TEVIMBRA®, which will launch in the first EU countries later in
2024. TEVIMBRA is approved in the U.S. and EU for advanced or
metastatic ESCC after prior chemotherapy and is under review by the
European Medicines Agency and the U.S. Food and Drug Administration
as a first-line treatment for patients with unresectable,
recurrent, locally advanced or metastatic ESCC and for first-line
gastric or gastroesophageal junction cancers.
The EC approval is based on the results from three Phase 3
studies in the RATIONALE program that enrolled 1,499 patients:
- RATIONALE 307 (NCT03594747) is an open-label, randomized Phase
3 trial that enrolled 360 patients with advanced squamous NSCLC.
The study met its primary endpoint, with first-line tislelizumab in
combination with chemotherapy resulting in statistically
significant improvement in progression free survival (PFS), as well
as higher objective response rates and a manageable
safety/tolerability profile, regardless of PD-L1 expression. The
most common grade ≥3 treatment emergent adverse events (TEAEs) were
decreased neutrophil levels, neutropenia and leukopenia. See full
study results published in JAMA Oncology.
- RATIONALE 304 (NCT03663205) is an open-label, randomized Phase
3 trial that enrolled 334 patients with locally advanced or
metastatic non-squamous NSCLC. The study met its primary endpoint,
with first-line tislelizumab in combination with chemotherapy
resulting in statistically significant improvement in PFS compared
to chemotherapy (HR: 0.65 [95% CI: 0.47-0.91]; P=0.0054) along with
higher response rates and longer response duration. The most common
grade ≥3 TEAEs were associated with chemotherapy and included
neutropenia and leukopenia. See full study results published in the
Journal of Thoracic Oncology.
- RATIONALE 303 (NCT03358875) is an open-label, randomized Phase
3 trial with tislelizumab versus docetaxel that enrolled 805
patients with advanced NSCLC who progressed on prior platinum-based
chemotherapy. The study met its primary endpoint, with second- or
third-line tislelizumab resulting in statistically significant and
clinically meaningful improvement in overall survival compared with
docetaxel in the intent-to-treat population (HR: 0.66 [95% CI:
0.56-0.79]; P<0.0001), regardless of PD-L1 expression. The most
commonly reported grade ≥3 TEAEs were pneumonia, anemia and
dyspnea. See full study results published in the Journal of
Thoracic Oncology.
BeiGene has launched more than 17 potentially
registration-enabling trials with tislelizumab, of which 11 Phase 3
randomized trials and four Phase 2 trials have already had positive
readouts. Through these trials, tislelizumab has demonstrated its
potential to 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
tislelizumab globally to date.
About NSCLC
Lung cancer is the second most common type of cancer and the
leading cause of cancer-related death worldwide.1 Lung cancer is
the third most common cancer in Europe; NSCLC represents 85–90% of
all lung cancers.2 In 2020, the number of new cases of lung cancer
diagnosed in Europe was estimated at 477,534.3
About 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.
Important Safety Information
The full European Summary of Product Characteristics (SmPC) for
the NSCLC indications for tislelizumab, which includes safety data
for NSCLC and ESCC, is available from the European Medicines
Agency.
About BeiGene
BeiGene is a global oncology 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, X (formerly known as Twitter), and Facebook.
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 fulfill its commitment to bring tislelizumab
to more patients around the world; tislelizumab’s potential to
deliver clinically meaningful improvements in survival benefits and
quality of life for hundreds of thousands of cancer patients across
a range of tumor types; 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 Globocan 2020. 900-world-fact-sheets.pdf
(iarc.fr).
2 European Society of Medical Oncology.
What is Non-Small-Cell Lung Cancer?
https://www.esmo.org/content/download/7252/143219/file/en-non-small-cell-lung-cancer-guide-for-patients.pdf.
3 Sung H, et al. Global cancer statistics
2020: GLOBOCAN estimates of incidence and mortality worldwide for
36 cancers in 185 countries. CA Cancer J Clin.
2021;71(3):209-49.
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version on businesswire.com: https://www.businesswire.com/news/home/20240423616830/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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