Tislelizumab demonstrated non-inferiority for
overall survival and favorable safety profile versus sorafenib in
global Phase 3 trial
Additional poster presentations show breadth of
tislelizumab global clinical development program as single-agent
treatment and in combination
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global,
science-driven biotechnology company focused on developing
innovative and affordable medicines to improve treatment outcomes
and access for patients worldwide, shared updates from its solid
tumor development program for cornerstone PD-1 antibody
tislelizumab at the European Society for Medical Oncology (ESMO)
Congress 2022 in Paris.
Results from the Phase 3 RATIONALE 301 trial of tislelizumab
versus sorafenib as first-line treatment in patients with
unresectable hepatocellular carcinoma were accepted as a
late-breaking abstract (LBA36) and presented at an oral session on
Saturday, September 10. In the final analysis of 674 patients
enrolled from Asia, Europe, and U.S., RATIONALE 301 met its primary
endpoint of overall survival (OS) non-inferiority, with a median OS
of 15.9 months for tislelizumab compared with an OS of 14.1 months
for sorafenib (HR: 0.85 [95.003% CI: 0.712, 1.019]); superiority
was subsequently tested, which was not met. OS data were consistent
across all pre-specified subgroups, including regions.
In the RATIONALE 301 trial, tislelizumab was associated with a
higher objective response rate (ORR) (14.3% vs. 5.4%) and more
durable responses (median duration of response (DoR) 36.1 months
vs. 11.0 months) compared with sorafenib. Median progression-free
survival (PFS) for tislelizumab versus sorafenib was 2.1 months vs.
3.4 months respectively; HR: 1.11 [95% CI: 0.92, 1.33].
The safety profiles for tislelizumab and sorafenib treatments
were consistent with previous studies, and tislelizumab
demonstrated a comparatively favorable profile versus sorafenib
with lower incidence rates of grade >3 adverse events (AEs) and AEs leading to
discontinuation (48.2% vs 65.4% and 10.9% vs 18.5% respectively).
AEs leading to death were low across both tislelizumab (4.4%) and
sorafenib (5.2%) arm.
“The RATIONALE 301 study results confirm a durable overall
survival benefit of single agent tislelizumab and we are pleased
that the safety profile for tislelizumab is consistent with
previous studies. While targeted therapies can be an important
treatment modality for advanced hepatocellular cancer, the safety
and tolerability profile remain an important consideration,” said
Mark Lanasa, M.D., Ph.D, Chief Medical Officer, Solid Tumors, at
BeiGene. “We’re pleased to share the data at ESMO today and to
engage with leading oncology researchers about our expansive
clinical development program for tislelizumab in solid tumors.”
In addition to the late-breaking Phase 3 RATIONALE 301 results,
BeiGene shared posters demonstrating a consistent response for
tislelizumab across pre-specified subgroups in a Phase 3 trial and
indications of anti-tumor activity and tolerable safety profile in
a Phase 1 trial with tislelizumab in combination with chemotherapy
and investigational anti-TIGIT antibody ociperlimab:
- Abstract 1031P – RATIONALE 303 (NCT03358875):
Tislelizumab demonstrated favorable OS, PFS, DoR, and ORR compared
with docetaxel, regardless of subgroup, in a prespecified analysis
of Asian versus non-Asian patients in the global RATIONALE 303
study of tislelizumab versus docetaxel as second- or third-line
therapy in previously treated patients with locally advanced
non-small cell lung cancer (NSCLC) Lower rates of
treatment-emergent adverse events were reported for tislelizumab
versus docetaxel (41.1% vs 75.2% of Asian patients and 45.9% vs
72.9% of non-Asian patients, respectively).
- Abstract 1017P –AdvanTIG-105 (NCT04047862): Ociperlimab
and tislelizumab plus chemotherapy demonstrated antitumor activity
in cohorts 1 and 2 of this Phase 1b dose-expansion study and the
recommended Phase 2 dose showed a manageable safety profile in
patients with metastatic squamous and non-squamous NSCLC.
BeiGene also shared posters describing the trial design for
ongoing tislelizumab combination clinical trials:
- Abstract 1194TiP – AdvanTIG-205 (NCT05014815): Phase 2
trial of ociperlimab + tislelizumab + chemotherapy in first line
treatment of patients with locally advanced, unresectable, or
metastatic NSCLC.
- Abstract 1187TiP – BGB-A317-Sitra-301 (NCT04921358):
Phase 3 study of tislelizumab with sitravatinib versus chemotherapy
in patients with locally advanced/metastatic NSCLC previously
treated with chemo and an anti-programmed cell death protein
1/ligand 1 antibody.
About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody
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.
Tislelizumab is the first investigational medicine from
BeiGene’s immuno-oncology biologics program and is being evaluated
in solid tumor and hematologic malignancies, as monotherapy and in
combination.
The global tislelizumab clinical development program includes
more than 11,000 subjects enrolled to-date in 30 countries and
regions. More information on the tislelizumab development program,
including clinical trials and regulatory submissions, can be found
on the Tislelizumab Fact Sheet in our corporate press kit.
About RATIONALE 301
RATIONALE 301 (NCT03412773) is a global, Phase 3, randomized,
open-label study of tislelizumab compared with sorafenib as a
first-line treatment in adult patients with unresectable HCC. The
primary endpoint of the study is non-inferiority of OS between the
two treatment groups. The key secondary endpoint is ORR, as
assessed by Blinded Independent Review Committee (BIRC) per RECIST
v1.1. Other secondary endpoints include other efficacy assessments
such as PFS, DoR, and Time to Progression per BIRC, as well as
measures of health-related quality of life, and safety and
tolerability.
BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class
clinical candidates internally or with like-minded partners to
develop impactful and affordable medicines for patients across the
globe. We have a growing R&D and medical affairs team of
approximately 3,300 colleagues dedicated to advancing more than 100
clinical trials that have involved more than 16,000 subjects. Our
expansive portfolio is directed predominantly by our internal
colleagues supporting clinical trials in more than 45 countries and
regions. Hematology-oncology and solid tumor targeted therapies and
immuno-oncology are key focus areas for the Company, with both
mono- and combination therapies prioritized in our research and
development. BeiGene currently has three approved medicines
discovered and developed in our own labs: BTK inhibitor BRUKINSA®
in more than 50 markets including the U.S., China, the European
Union, Great Britain, Canada, Australia, and South Korea; and the
non-FC-gamma receptor binding anti-PD-1 antibody, tislelizumab, as
well as the PARP inhibitor, pamiparib, in China.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialize a range of oncology medicines in China licensed from
Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also
plan to address greater areas of unmet need globally through our
other collaborations including with Mirati Therapeutics, Seagen,
and Zymeworks.
In January 2021, BeiGene and Novartis announced a collaboration
granting Novartis rights to co-develop, manufacture, and
commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North
America, Europe, and Japan. Building upon this productive
collaboration, BeiGene and Novartis announced an option,
collaboration, and license agreement in December 2021 for BeiGene’s
TIGIT inhibitor, ociperlimab, that is in Phase 3 development.
Novartis and BeiGene also entered into a strategic commercial
agreement through which BeiGene will promote five approved Novartis
Oncology products across designated regions of China.
About BeiGene
BeiGene is a global biotechnology company that is developing and
commercializing innovative and affordable oncology medicines to
improve treatment outcomes and access for far more 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 8,500 colleagues spans five
continents, with administrative offices in Beijing, China;
Cambridge, U.S.; and Basel, Switzerland. To learn more about
BeiGene, please visit www.beigene.com and follow us on Twitter at
@BeiGeneGlobal.
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 of anticipated clinical development,
regulatory milestones and commercialization of tislelizumab,
ociperlimab and sitravatinib, and BeiGene’s plans, commitments,
aspirations, and goals under the headings “BeiGene Oncology” and
“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 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 and commercialization of its drug candidates and
achieve and maintain profitability; the impact of the COVID-19
pandemic on BeiGene’s clinical development, regulatory, commercial,
manufacturing, and other operations, as well as 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220909005536/en/
Investor Kevin Mannix +1 240-410-0129 ir@beigene.com
Media Emily Collins +1 201-201-4570 media@beigene.com
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