Recommendation based on results of three Phase
3 clinical trials demonstrating benefit of tislelizumab as a first-
and second-line treatment for patients with NSCLC
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) issued a positive opinion recommending approval of
tislelizumab as a treatment for non-small cell lung cancer (NSCLC)
across three indications:
- 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.
“Through three Phase 3 clinical trials enrolling nearly 1,500
patients across the world including in the European Union,
tislelizumab has been shown to be an effective therapy for patients
with treatment-naïve and treatment-resistant NSCLC,” said Mark
Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at
BeiGene. “Today's positive CHMP opinion brings us one step closer
to providing an important treatment option to patients in Europe
with lung cancer, which is among the most common cancers and a
leading cause of cancer death in the region.”
The Marketing Authorization Application (MAA) for NSCLC is based
on results from three Phase 3 studies that enrolled 1,499 patients.
First-line combination therapy results from RATIONALE 307
evaluating tislelizumab in advanced squamous NSCLC and from
RATIONALE 304 evaluating tislelizumab in locally advanced or
metastatic non-squamous NSCLC were published in JAMA Oncology and
in the Journal of Thoracic Oncology, respectively. Second-line
monotherapy results from RATIONALE 303 evaluating tislelizumab in
previously treated advanced NSCLC were published in the Journal of
Thoracic Oncology.
Dr. Lanasa added, “As we strengthen our global portfolio in
solid tumors, this positive CHMP opinion marks another significant
milestone in the European Union for tislelizumab only a few months
after it was approved for the treatment of advanced esophageal
squamous cell carcinoma. We will continue to follow the science and
data to advance tislelizumab as a monotherapy and combination
treatment to address unmet needs of patients across the world.”
Tislelizumab, under the brand name TEVIMBRA®, received
approval from the European Commission for advanced or metastatic
ESCC after prior chemotherapy in 2023 and is currently under review
with the U.S. Food and Drug Administration. Tislelizumab is also
under review by the FDA as a first-line treatment for patients with
unresectable, recurrent, locally advanced, or metastatic ESCC.
BeiGene has launched more than 17 potentially registration-enabling
trials with tislelizumab with over 13,000 patients enrolled
to-date, of which 15 have already reported positive readouts. In
these clinical studies, tislelizumab has consistently demonstrated
its ability deliver clinically meaningful improvements in survival
and quality of life with a positive benefit-risk balance for 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 to date.
About RATIONALE 307 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
(ORRs) and a manageable safety/tolerability profile, regardless of
PD-L1 expression. The median PFS was 7.7 months for tislelizumab in
combination with paclitaxel and carboplatin (hazard ratio, HR: 0.45
[95% CI: 0.326-0.619]; P< 0.001) and 9.6 months for tislelizumab
in combination with nab-paclitaxel and carboplatin (HR: 0.43 [95%
CI: 0.308-0.60]; P< 0.001) versus 5.5 months for paclitaxel and
carboplatin alone, at a median study follow-up of 8.6 months. The
most common grade ≥3 treatment emergent adverse events were
decreased neutrophil levels, neutropenia and leukopenia.
About RATIONALE 304 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 median PFS in the overall and in the
PD-L1≥50% populations was 9.7 months for tislelizumab in
combination with platinum (carboplatin or cisplatin) and pemetrexed
versus 7.6 months for platinum and pemetrexed alone and 14.6 months
with tislelizumab in combination with chemotherapy vs. 4.6 months
with chemotherapy alone (stratified HR: 0.31 [95% CI: 0.178-0.547])
respectively, at a median study follow-up of 9.8 months. The most
common grade ≥3 treatment emergent adverse events were associated
with chemotherapy and included neutropenia and leukopenia.
About RATIONALE 303 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 (OS) 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 median OS was
16.9 months for tislelizumab versus 11.9 months for docetaxel. At
the final analysis, OS in the PD-L1 positive population was also
significantly improved in favor of tislelizumab (median 19.3 versus
11.5 months, respectively; HR: 0.53 [95% CI: 0.41-0.70];
P<0.0001). The most commonly reported grade ≥3 treatment
emergent adverse events were pneumonia, anemia and dyspnea.
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.
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 the effectiveness
of tislelizumab as a treatment for patients with treatment-naïve
and treatment-resistant NSCLC; the future advancement of
tislelizumab as a therapy to address unmet needs of patients across
the world; the ability of tislelizumab to consistently deliver
clinically meaningful improvements in survival and quality of life
for cancer patients; 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 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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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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