- First-line tislelizumab plus chemotherapy demonstrated a median
overall survival of 15.0 months versus 12.9 months for placebo plus
chemotherapy in the intent-to-treat group of the Phase 3 RATIONALE
305 trial
- The safety profile for tislelizumab in combination with
chemotherapy was manageable and in line with the known safety
profile of anti-PD-1 antibodies
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced results from the final
analysis of the Phase 3 RATIONALE 305 trial showing tislelizumab
plus chemotherapy significantly improved overall survival (OS) in
the intent-to-treat (ITT) population as a first-line treatment for
patients with advanced gastric or gastroesophageal junction
adenocarcinoma (GC/GEJC). No new safety signals were identified.
Study results will be featured as a late-breaking oral presentation
on October 21 at 5:25 p.m. CEST at the European Society for Medical
Oncology (ESMO) Congress 2023 (Abstract #LBA80).
“Gastric cancer is a devastating disease that affects millions
of people worldwide. Unfortunately, patients with advanced or
metastatic conditions have a poor prognosis and urgently need more
treatment options in the first-line setting,” said Mark Lanasa,
M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “These
data show that tislelizumab plus chemotherapy resulted in
significant overall survival improvement compared with chemotherapy
alone in the intent-to-treat patient group. These results and
positive findings build upon the data presented earlier this year
in the high PD-L1 expression group and add to the growing body of
evidence demonstrating the potential for tislelizumab to help
patients with advanced gastric cancer or gastroesophageal junction
cancer.”
In the final analysis of 997 intent-to-treat patients from the
Phase 3 RATIONALE 305 trial, tislelizumab plus chemotherapy
(oxaliplatin 130 mg/m2 IV Q3W (day 1) and oral capecitabine 1000
mg/m2 twice daily (days 1-14) Q3W (XELOX), or cisplatin 80 mg/m² IV
Q3W (day 1) and 5-fluorouracil 800 mg/m2/day IV (days 1-5) Q3W
(FP)) showed a median OS of 15.0 months compared with an OS of 12.9
months for chemotherapy alone (HR: 0.80 [95% CI: 0.70, 0.92]; P =
0.0011) in first line advanced GC/GEJC.
“The data from the RATIONALE 305 study suggest that tislelizumab
plus chemotherapy represents a potential new first-line treatment
option for patients with advanced GC/GEJC regardless of PD-L1
expression status,” said Rui-Hua Xu, M.D., Ph.D., Director of the
Cancer Control Center of Sun Yat-sen University and principal
investigator for the RATIONALE 305 trial. “Tislelizumab plus
chemotherapy provided significant and clinically meaningful overall
survival benefit versus chemotherapy in all randomized patients
with previously untreated, HER2-negative advanced GC/GEJC.”
In the trial, tislelizumab plus chemotherapy was associated with
a higher objective response rate (ORR) (47.3% vs. 40.5%) and median
duration of response (mDoR) (8.6 months vs. 7.2 months) compared to
placebo plus chemotherapy alone. Median progression-free survival
(PFS) for tislelizumab plus chemotherapy was 6.9 months vs. 6.2
months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]).
About RATIONALE 305 (NCT03777657) RATIONALE 305 is a
randomized, double-blind, placebo-controlled, global Phase 3 trial
comparing the efficacy and safety of tislelizumab combined with
platinum and fluoropyrimidine chemotherapy and placebo combined
with platinum and fluoropyrimidine chemotherapy as a first-line
treatment for patients with advanced unresectable or metastatic
GC/GEJ adenocarcinoma. A total of 997 patients from 13 countries
and regions across the world were enrolled and randomized 1:1 to
receive either tislelizumab or placebo in combination with
chemotherapy.
The primary endpoint for the trial is OS, with prespecified
hierarchy testing for the PD-L1 high population followed by the ITT
population. High PD-L1 expression is defined as PD-L1 score ≥ 5% by
VENTANA SP263 assay, assessed by blinded independent central
laboratory. OS analysis in the ITT population would be performed
only after the OS analysis in the PD-L1 high population was
demonstrated to be statistically significant, favoring the
tislelizumab and chemotherapy arm. Secondary endpoints include
progression-free survival, overall response rate, duration of
response, and safety.
Interim results were shared in an oral presentation at the 2023
ASCO Gastrointestinal Cancers Symposium. In patients with GC/GEJC
with high PD-L1 expression, tislelizumab plus chemotherapy
demonstrated statistically significant and clinically meaningful
improvement in OS versus placebo plus chemotherapy [median OS: 17.2
vs 12.6 months; HR 0.74 (95% CI 0.59, 0.94); P=0.0056] with a
manageable safety profile, and no new safety signals were
identifiedi.
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.ii,iii,iv,v
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 for
tislelizumab to help patients with advanced gastric cancer or
gastroesophageal junction cancer; 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 Moehler, Markus H., et al.
"Rationale 305: Phase 3 study of tislelizumab plus chemotherapy vs
placebo plus chemotherapy as first-line treatment (1L) of advanced
gastric or gastroesophageal junction adenocarcinoma (GC/GEJC)."
Journal of Clinical Oncology 41, no. 4_suppl (February 01, 2023)
286-286 DOI: 10.1200/JCO.2023.41.4_suppl.286 ii Desai J et al.
Abstract Book of the 42 ESMO Congress (ESMO 2017). Annals of
Oncology 2017. Volume 28, supplement 5; v122–v141. iii 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 iv
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 v 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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Investors: Liza Heapes +1 857-302-5663 ir@beigene.com
Media: U.S. Media Kyle Blankenship +1 667-351-5176
media@beigene.com
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