BeiGene Highlights TEVIMBRA® Data in Lung and Gastrointestinal Cancers at ESMO 2024
September 09 2024 - 1:00AM
Business Wire
Results from RATIONALE-315, 307 and 305 support
the benefits of PD-1 inhibitor TEVIMBRA (tislelizumab) in non-small
cell lung cancer and gastric cancer/gastroesophageal junction
cancer
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced it will share new data for
TEVIMBRA® (tislelizumab) at the European Society of Medical
Oncology 2024 Congress (ESMO 2024) in Barcelona, Spain, September
13-17, 2024. BeiGene has seven abstracts accepted at ESMO 2024,
with one selected for the special session revisiting the ESMO
Virtual Plenary held in February 2024.
New Data Add to Evidence for TEVIMBRA Across Multiple Disease
States
- As an encore to the ESMO plenary, interim results from the
RATIONALE-315 study show the statistically significant event-free
survival (EFS) and trend for overall survival (OS) benefit favoring
neoadjuvant tislelizumab plus chemotherapy with adjuvant
tislelizumab vs. placebo plus chemotherapy with adjuvant placebo
for patients with resectable non-small cell lung cancer (NSCLC)
(session #VP1-2024, Sept. 13 from 4:17-4:29 p.m. CEST). These
results further reinforce the data presented at ESMO 2023 showing
major pathologic response (MPR) and pathologic complete response
(pCR) rate were significantly improved: 56.2% vs 15.0% (P<.0001)
and 40.7% vs 5.7% (P<.0001), respectively. The safety profile of
the tislelizumab arm was consistent with that of individual
therapies, with 72.1% (vs. 66.4% in the placebo arm) of patients in
the tislelizumab arm experiencing grade ≥3 treatment-related
adverse events (TRAEs) and 15.5% (vs. 8.0% in the placebo arm)
experiencing serious TRAEs. The most common TRAEs were decreased
neutrophil count, decreased white blood cell count and alopecia.
Improvement in symptomology from RATIONALE-315 will also be shown
as patient-reported outcomes (poster #1213P, Sept. 14).
- Three-year overall survival data from RATIONALE-305 continue to
demonstrate the long-term efficacy and safety of tislelizumab plus
chemotherapy in patients with first-line advanced or metastatic
gastric cancer/gastroesophageal junction cancer (GC/GEJC) (poster
#1437P, Sept. 16), as well as improvements in patient-reported
outcomes (poster #1449P, Sept. 16).
- Long-term outcomes in the ITT population as well as those
receiving long-term exposure to tislelizumab plus chemotherapy as
treatment for first line squamous NSCLC in RATIONALE-307 show a
continued OS benefit with clinically promising four-year OS rates
(poster #1323P, Sept. 14).
- Relative effectiveness of tislelizumab vs. other anti-PD-1
treatments approved in the European Union and UK for second-line
esophageal squamous cell carcinoma (ESCC) using anchored simulated
treatment comparison of data from RATIONALE-302 and comparator
clinical studies (poster #1417P, Sept. 16).
“TEVIMBRA has shown potential across multiple disease states,
and the data at ESMO 2024 further supports its position as the
foundational asset of our solid tumor portfolio,” said Dr. med.
Jan-Henrik Terwey, Vice President, Medical Affairs Europe at
BeiGene. “As part of our commitment to bring innovative cancer
medicines to more patients, we recently launched TEVIMBRA in
EMA-approved indications in Germany, Austria and Norway, and we are
working to make TEVIMBRA available across Europe.”
TEVIMBRA in Europe
BeiGene recently launched TEVIMBRA in the first European
countries following EU marketing authorizations for the treatment
of eligible patients with ESCC and NSCLC. TEVIMBRA is also approved
in the UK and Switzerland for eligible patients with advanced or
metastatic ESCC.
“Advanced or metastatic ESCC and NSCLC are aggressive cancers
with limited treatment options,” said Markus Moehler, M.D., Ph.D.,
of the Johannes Gutenberg University Medical Center Mainz in
Germany. “The availability of tislelizumab for these patients
represents an important next step to advance the treatment
landscape.”
The European Commission approvals were based on the results from
four randomized Phase 3 studies in the RATIONALE program:
RATIONALE-302 (NCT03430843) for ESCC and RATIONALE-307
(NCT03594747), RATIONALE-304 (NCT03663205) and RATIONALE-303
(NCT03358875) for NSCLC. The approved indications for TEVIMBRA in
the EU 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.
- As monotherapy for the treatment of adult patients with
unresectable, locally advanced or metastatic ESCC after prior
platinum-based chemotherapy.
About TEVIMBRA® (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. To learn more about
BeiGene, please visit www.beigene.com and follow us on LinkedIn, X
(formerly known as Twitter), Facebook and Instagram.
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
plans to make TEVIMBRA available across Europe; 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; BeiGene’s 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.
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Media: Maryline Iva +41 61 685 2090
maryline.iva@beigene.com
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