- Late-breaking ESMO data show 56.2% of patients with resectable
NSCLC who received tislelizumab plus chemotherapy before surgery
achieved major pathological response, versus 15.0% of those treated
with neoadjuvant chemotherapy alone
- Analysis also found 40.7% of patients on the tislelizumab-based
regimen achieved the key secondary endpoint of pathological
complete response, compared to 5.7% of patients who received
neoadjuvant chemotherapy alone
- In a subsequent interim analysis from RATIONALE 315, addition
of tislelizumab to neoadjuvant platinum-based chemotherapy followed
by adjuvant tislelizumab monotherapy demonstrated statistically
significant improvement in event-free survival compared to
neoadjuvant chemotherapy alone
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced that the Phase 3 RATIONALE
315 study met its dual primary endpoints of major pathological
response (MPR) by Blinded Independent Pathology Review (BIPR) and
event-free survival (EFS) by Blinded Independent Central Review
(BICR), demonstrating statistically significant and clinically
meaningful improvements in patients with resectable Stage II or
IIIA NSCLC treated with tislelizumab in combination with
chemotherapy before surgery and as a single agent after surgery
versus neoadjuvant chemotherapy plus placebo followed by placebo
after surgery. The tislelizumab plus chemotherapy regimen also
showed a statistically significant improvement in pathological
complete response (pCR), the key secondary endpoint, after
neoadjuvant therapy versus chemotherapy. The MPR and pCR data will
be featured as a late-breaking mini oral presentation on October 23
at 2:55 p.m. CEST at the European Society for Medical Oncology
(ESMO) Congress 2023 (Abstract #LBA58).
In the study, 56.2% of NSCLC patients treated with tislelizumab
in combination with chemotherapy before surgery achieved MPR,
compared to 15.0% of patients treated with chemotherapy alone
(difference: 41.1%; 95% CI: 33.2-49.1, p<0.0001). MPR is defined
as less than 10% residual viable tumor after neoadjuvant therapy.
Additionally, 40.7% of patients on the tislelizumab-based regimen
achieved pCR, defined as no viable residual tumor after neoadjuvant
therapy, compared to 5.7% of patients treated with chemotherapy
alone (difference: 35.0%; 95% CI: 27.9-42.1, p<0.0001).
Tislelizumab plus chemotherapy was generally well tolerated, with
no new safety signals identified.
Additionally, at a recent prespecified interim analysis
conducted by the independent data monitoring committee (IDMC), the
tislelizumab-based regimen demonstrated a statistically significant
improvement in EFS per assessment by BICR. Detailed results will be
submitted for presentation at an upcoming medical conference.
"Lung cancer remains the most common type of cancer and the
leading cause of cancer-related death worldwide. Despite available
treatment options, rates of recurrence within five years remain
unacceptably high, underscoring the need for innovative new
neoadjuvant and adjuvant interventions to help improve patient
outcomes,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer,
Solid Tumors at BeiGene. “The data from RATIONALE 315 are
encouraging and demonstrate that early integration of tislelizumab
into the treatment paradigm may help both improve responses at the
time of surgery and reduce the recurrence risk for these patients.
These results add to the growing evidence suggesting the potential
benefits of tislelizumab in treating patients with NSCLC.”
About RATIONALE 315 (NCT04379635)
RATIONALE 315 is a randomized, double-blind, placebo-controlled,
Phase 3 trial evaluating the efficacy and safety of neoadjuvant
tislelizumab plus platinum-based doublet chemotherapy, followed by
surgery and subsequent adjuvant tislelizumab, compared to placebo
plus neoadjuvant platinum-based doublet chemotherapy followed by
surgery and subsequent adjuvant placebo in patients with resectable
Stage II or IIIA NSCLC. The primary endpoints are MPR rate by BIPR
and EFS by BICR. The key secondary endpoint is pCR. Other secondary
endpoints included overall survival (OS), objective response rate
(ORR), disease-free survival (DFS) as assessed by BICR, and
investigator assessed EFS. A total of 453 patients were enrolled
and randomized 1:1 to receive either tislelizumab or placebo in
combination with chemotherapy.
About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody,
with high affinity and binding specificity against PD-1,
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.i,ii,iii,iv
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.
Tislelizumab is currently under review by the U.S. Food and Drug
Administration (FDA) and received approval by the European
Commission for advanced or metastatic ESCC after prior
chemotherapy. Additionally, the FDA recently accepted for review a
Biologics License Application for tislelizumab as a first-line
treatment for patients with unresectable, recurrent, locally
advanced, or metastatic ESCC. The European Medicines Agency (EMA)
is reviewing a marketing authorization application for tislelizumab
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 tislelizumab are also under review by
authorities in Australia, Brazil, China, Korea, Israel, New
Zealand, Singapore, Switzerland, and the U.K. Tislelizumab is
approved for 11 indications in China and is the leading PD-1
inhibitor in the country.
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
the potential benefits of tislelizumab in treating patients with
NSCLC; 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 Desai J et al. Abstract Book of the 42
ESMO Congress (ESMO 2017). Annals of Oncology 2017. Volume 28,
supplement 5; v122–v141.
ii Zhang T et al. “The binding of an
anti-PD-1 antibody to Fcγ has a profound impact on its biological
functions.” Cancer Immunology, Immunotherapy. Volume 67, issue 7
(July 2018) 1079–1090
iii Arlauckas SP et al. “In vivo imaging
reveals a tumor-associated macrophage-mediated resistance pathway
in anti-PD-1 therapy.” Science Translation Medicine; 2017 May
10;9(389):eaal3604. DOI: 10.1126/scitranslmed.aal3604
iv Dahan R et al. “FcyRs Modulate the
Anti-tumor Activity of Antibodies Targeting the PD-1/PD-L1 Axis.”
Cancer Cell. Volume 28, issue 3 (September 2015); 285–295.
DOI:10.1016/j.ccell.2015.08.004
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Investor Contact: Liza Heapes +1 857-302-5663
ir@beigene.com
Media Contact: 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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