Two late-breaking abstracts highlight
tislelizumab plus chemotherapy combination strategy in solid tumors
with high unmet need
Additional presentations showcase potential of
biology-driven tislelizumab combination approaches with BeiGene
pipeline molecules
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced the presentation of
promising new data showcasing BeiGene’s robust, science-driven
solid tumor portfolio of commercialized and pipeline medicines at
the European Society for Medical Oncology (ESMO) Congress 2023.
Highlights include the presentations of two late-breaking
abstracts for tislelizumab, an anti-PD-1 antibody and the first
medicine to emerge from BeiGene’s immuno-oncology biologics
program:
- Final analysis from the global, Phase 3 RATIONALE-305 study
(NCT03777657) evaluating tislelizumab plus chemotherapy as a
first-line treatment of advanced gastric or gastroesophageal
junction adenocarcinoma (GC/GEJC)
- Final analysis of pathological response to neoadjuvant
tislelizumab plus chemotherapy in patients with resectable Stage
II-IIIA non-small cell lung cancer (NSCLC) in results from the
Phase 3 RATIONALE-315 study (NCT04379635)
“At ESMO 2023, we look forward to presenting results from
several clinical trials of tislelizumab in combination with other
therapies across multiple disease areas and lines of treatment,”
said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors
at BeiGene. “Tislelizumab is the cornerstone of BeiGene’s diverse
pipeline of pan-solid tumor programs for the next wave of
immuno-oncology targets. We are delighted to have recently regained
the global rights to this important medicine and remain dedicated
to following the science and data to advance new combination
strategies for the treatment of solid tumors.”
TEVIMBRA® (tislelizumab) was recently approved in the European
Union (EU) as monotherapy for the treatment of adult patients with
unresectable, locally advanced or metastatic esophageal squamous
cell carcinoma (ESCC) after prior platinum-based chemotherapy.
Additionally, the U.S. Food and Drug Administration (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.
More details on BeiGene’s abstracts are available in the ESMO
Programme.
Presentations of Company-Sponsored Trials
Tislelizumab
- Tislelizumab (TIS) Plus Chemotherapy (Chemo) vs Placebo (PBO)
Plus Chemo as First-Line (1L) Treatment of Advanced Gastric or
Gastroesophageal Junction Adenocarcinoma (GC/GEJC): Final Analysis
Results of the RATIONALE-305 Study (Abstract #LBA80)
- Mini oral presentation, Saturday, October 21, 5:25-5:30 PM
CEST
- Pathological Response to Neoadjuvant Tislelizumab (TIS) Plus
Platinum-Doublet (PtDb) Chemotherapy (CT) in Resectable Stage
II-IIIA NSCLC Patients (pts) in the Phase 3 (Ph3) RATIONALE-315
Trial (Abstract #LBA58)
- Mini oral presentation, Monday, October 23, 2:55-3:00 PM
CEST
- Randomized, Global, Phase 3 Study of Tislelizumab (tis) +
Chemotherapy (chemo) vs Placebo (PBO) + Chemo as First-line (1L)
Treatment for Advanced/Metastatic Esophageal Squamous Cell
Carcinoma (ESCC): RATIONALE-306 Study Update (Abstract #1514P)
- Poster presentation, Monday, October 23
- Long-term Follow-up of a Phase 2 Study of Tislelizumab (TIS)
Monotherapy in Patients (pts) With Previously Treated, Locally
Advanced, Unresectable or Metastatic Microsatellite
Instability-high (MSI-H) or Mismatch Repair-deficient (dMMR) Solid
Tumors. BGB-A317-209 Study (Abstract #1057P)
- Poster presentation, Monday, October 23
Ociperlimab Development Program
- AdvanTIG-203: Phase 2 Randomized, Multicenter Study of
Ociperlimab (OCI) + Tislelizumab (TIS) in Patients (pts) With
Unresectable, Locally Advanced, Recurrent/Metastatic Esophageal
Squamous Cell Carcinoma (ESCC) and Programmed Cell Death-Ligand 1
(PDL1) Positivity (Abstract #1020MO)
- Mini oral presentation, Saturday, October 21, 4:30-4:35 PM
CEST
- AdvanTIG-206: Phase 2 randomized open-label study of
ociperlimab (oci) + tislelizumab (tis) + BAT1706 (bevacizumab
biosimilar) versus tis + BAT1706 in patients (pts) with advanced
hepatocellular carcinoma (HCC) (Abstract #945MO)
- Mini oral presentation, Saturday, October 21, 4:30-4:35 PM
CEST
- AdvanTIG-202: Phase 2 Randomized, Multicenter, Open-Label Study
of Tislelizumab (tis) With or Without Ociperlimab (oci) in Patients
(pts) With Previously Treated Recurrent/Metastatic (R/M) Cervical
Cancer (CC) (Abstract #744MO)
- Mini oral presentation, Sunday, October 22, 10:55-11:00 AM
CEST
- AdvanTIG-105: Phase 1b Dose-expansion Study of Ociperlimab
(OCI) + Tislelizumab (TIS) with Chemotherapy (CT) in Patients (pts)
with Metastatic Esophageal Squamous Cell Carcinoma (ESCC) and
Esophageal Adenocarcinoma (EAC) (Abstract #1533P)
- Poster presentation, Monday, October 23
Additional Pipeline Assets
- Zanidatamab (zani) Plus Chemotherapy (chemo) and Tislelizumab
(tis) as First-line (1L) Therapy for Patients (pts) With Advanced
HER2-positive (+) Gastric/Gastroesophageal Junction Adenocarcinoma
(GC/GEJC): Updated Results From a Phase 1b/2 Study (Abstract
#1518P)
- Poster presentation, Monday, October 23
- Phase (Ph) 1/2 Study of Sitravatinib (sitra) Alone or With
Tislelizumab (tis) in Advanced Hepatocellular Carcinoma (HCC) and
Gastric/Gastroesophageal Junction Cancer (GC/GEJC) (Abstract #948P)
- Poster presentation, Monday, October 23
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 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 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 as a treatment in 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, Cambridge, and 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
BeiGene’s advancement, anticipated clinical development, regulatory
milestones and commercialization of tislelizumab, ociperlimab and
other pipeline assets; BeiGene’s ability to advance new combination
strategies for the treatment of solid tumors; the general future of
BeiGene’s pipeline and programs; 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. Ann Oncol. 2017;28(suppl_5):v122–v141. ii Zhang
T et al. Cancer Immunol Immunother. 2018;67:1079–1090. iii
Arlauckas SP et al. Sci Transl Med. 2017;9:eaal3604. iv Dahan R et
al. Cancer Cell. 2015;28:285–295.
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version on businesswire.com: https://www.businesswire.com/news/home/20231016414274/en/
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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