BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024
BeiGene presents promising data on tislelizumab-containing immuno-oncology combinations and BGB-16673 at AACR 2024, showcasing advancements in cancer treatment and novel mechanisms.
The clinical potential of tislelizumab combinations for solid tumor treatments is a significant development in the field of immuno-oncology. The data presented at the AACR Annual Meeting indicates a forward momentum in the understanding and application of these therapies. Tislelizumab, an anti-PD1 antibody, is designed to restore the body's immune response against cancer cells. When combined with ociperlimab, an anti-TIGIT antibody, the potential for enhanced efficacy in treatment regimens for small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) is particularly notable. The ongoing global Phase 3 trial, AdvanTIG-302, which is nearing completion of enrollment, is especially critical as it targets stage IV, PD-L1 high NSCLC, a patient group that often has limited treatment options.
Furthermore, the preclinical data on BGB-16673, a BTK degrader, is promising for B-cell malignancies. BTK inhibitors are a class of drugs that block the BTK enzyme, playing a crucial role in the proliferation and survival of B-cells. The reported clinical responses from the Phase 1 study suggest that BGB-16673 could offer a new therapeutic option for patients with B-cell malignancies who have developed resistance to existing BTK inhibitors. The tolerability of this treatment in heavily pre-treated patients is also an encouraging sign for its future application.
The exploration of biomarkers in the context of ociperlimab plus tislelizumab for NSCLC is a critical step in personalizing cancer treatment. Biomarkers are biological molecules found in blood, other body fluids, or tissues that are a sign of a normal or abnormal process, or of a condition or disease. They can help predict who will benefit from a treatment, monitor the response and adjust therapies for better outcomes. The identification and validation of such biomarkers could significantly improve the precision of immuno-oncology treatments.
Additionally, the triple-combination therapy involving tislelizumab, LBL-007 (anti-LAG-3) and surzebiclimab (anti-TIM-3) represents an innovative approach to targeting multiple immune checkpoints simultaneously. The rationale behind this strategy is to overcome the complex mechanisms of immune evasion employed by tumors. The Phase 2 study focused on head and neck squamous cell carcinoma (HNSCC) could provide insights into the efficacy of this multi-pronged approach and pave the way for new treatment paradigms in solid tumors.
The data presented by BeiGene at the AACR Annual Meeting has potential implications for the company's financial future and the valuation of its stock. The progress in clinical trials and preclinical studies can be seen as an indicator of the company's research and development strength, which is a critical driver of long-term value creation in biopharmaceutical companies. Positive outcomes from these trials could lead to increased investor confidence, potential partnerships and revenue streams from new drug approvals.
However, investors should be aware of the inherent risks associated with clinical development, including the possibility of trial failures, regulatory hurdles and competition from other drugs in the pipeline. The market for oncology drugs is highly competitive and the success of BeiGene's candidates will depend not only on clinical efficacy and safety but also on their ability to differentiate from existing therapies and their cost-effectiveness. As such, the financial impact of these developments will be closely tied to the outcomes of ongoing and future clinical trials.
03/06/2024 - 06:00 AM
Multiple trials underscore the potential of tislelizumab-containing immuno-oncology combinations in a variety of solid tumor settings
Additional highlights include preclinical characterization data for an investigational BTK degrader, BGB-16673, currently in clinical development for B-cell malignancies, including mantle cell lymphoma
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. --(BUSINESS WIRE)--
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting April 5-10 in San Diego . BeiGene has nine abstracts scheduled for poster presentations at AACR.
“Our presentations at this year’s AACR showcase our ongoing development of tislelizumab combinations in solid tumors as we assess the clinical potential of multiple novel immuno-oncology candidates and make data-driven decisions for further development,” said Lai Wang, Ph.D., Global Head of Research & Development at BeiGene. “More broadly, they reflect our deep commitment to discovering innovative new medicines for cancer patients, including by pioneering novel mechanisms like targeted degradation.”
BeiGene will present results from the AdvanTIG-204 Phase 2 study of tislelizumab (anti-PD1) plus ociperlimab (anti-TIGIT) in first-line limited-stage small cell lung cancer (SCLC) as well as results of a biomarker study of the same doublet in the setting of first-line non-small cell lung cancer (NSCLC). An ongoing, global Phase 3 trial of ociperlimab plus tislelizumab in stage IV, PD-L1 high NSCLC, AdvanTIG-302, will complete enrollment this month (NCT04746924 ). An additional clinical presentation includes the first data from a Phase 1a dose escalation study of BGB-10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, plus tislelizumab in patients with solid tumors.
BeiGene will also be presenting preclinical characterizations of several novel molecules from its internal discovery engine, including a CEA x 4-1BB bispecific antibody and a chimeric degradation activation compound (CDAC) targeting BTK, BGB-16673. Clinical data from an ongoing Phase 1 study of BGB-16673 in relapsed/refractory B-cell malignancies were presented at ASH 2023, demonstrating clinical responses and a tolerable safety profile in heavily pre-treated patients with B-cell malignancies, including those with BTK inhibitor-resistant disease (NCT05006716 ).
An additional preclinical presentation highlights the therapeutic potential of the triple-combination of tislelizumab with anti-LAG-3 (LBL-007) and anti-TIM-3 (surzebiclimab); this combination is being evaluated in an ongoing Phase 2 study in head and neck squamous cell carcinoma (NCT05909904 ).
BeiGene Presentations During AACR 2024
Abstract Title
Abstract #
Presentation
Time (PDT)
Lead Author
Preclinical
Characterization of the correlation between BTK
degradation and tumor growth inhibition of the
BTK target protein degraders using PK/PD
modeling
2110
Monday, April 8
9 a.m. – 12:30 p.m.
Section 30
Board #1
Y. Wu
BGB-B167, a first-in-class 4-1BB/CEACAM5
bispecific antibody, exhibits potent in vitro and in
vivo anti-tumor activity and superior safety profile
in preclinical models
2371
Monday, April 8
9 a.m. – 12:30 p.m.
Section 38
Board #17
Z. Li
Translational assessment of triple combination
with tislelizumab (anti-PD-1), LBL-007 (anti-LAG-
3) and surzebiclimab (anti-TIM-3) highlights its
strong anti-tumor activity and clinical potential in
solid tumors such as HNSCC
4041
Tuesday, April 9
9 a.m. – 12:30 p.m.
Section 3
Board #17
H. Zhu
Clinical
Exploration of potential biomarkers correlated
with efficacy of ociperlimab (anti-TIGIT) plus
tislelizumab (anti-PD1) in 1L PD-L1+ non-small
cell lung cancer (NSCLC)
CT053
Monday, April 8
9 a.m. – 12:30 p.m.
Section 48
Board #3
S. Kim
A first in human, phase 1a, dose escalation study
of BGB 10188, a phosphatidylinositol 3 kinase
delta (PI3Kδ) inhibitor, + tislelizumab (anti-PD-1)
in patients with solid tumors
CT189
Tuesday, April 9
9 a.m. – 12:30 p.m.
Section 48
Board #17
R. Cosman
AdvanTIG-204: A phase 2, multicenter,
randomized, 3-arm, open-label study investigating
the preliminary efficacy and safety of ociperlimab
(anti-TIGIT) + tislelizumab (anti-PD-1) +
concurrent chemoradiotherapy (cCRT) in patients
with untreated limited-stage small cell lung cancer
(SCLC)
CT255
Tuesday, April 9
1:30 p.m. – 5 p.m. Section 48
Board #14
Y. Gong
BGB-A317-LBL-007-202 (NCT06010303 ): A
phase 2, randomized, active-controlled, open-
label study to evaluate the efficacy and safety of
LBL 007 (anti-LAG-3) in combination with
tislelizumab (TIS; anti-PD-1) plus chemotherapy
(chemo) as first-line (1L) treatment in patients
with unresectable locally advanced/metastatic
esophageal squamous cell carcinoma (ESCC)
CT274
Tuesday, April 9
1:30 p.m. – 5 p.m. Section 50
Board #4
S. Park
Liberty-201 (NCT05609370 ): Maintenance
fluoropyrimidine and bevacizumab with or without
anti-lymphocyte activation gene-3 (LAG-3)
antibody LBL-007 plus anti-programmed cell
death protein-1 (PD-1) antibody tislelizumab (TIS)
for patients (pts) with metastatic or unresectable
microsatellite stable (MSS)/mismatch repair
proficient (pMMR)colorectal cancer (CRC)
CT276
Tuesday, April 9 1:30 p.m. – 5 p.m.
Section 50
Board #6
H.-J. Lenz
BGB-LC-201 (NCT05635708 ): A phase 2, open-
label, multi-arm study of tislelizumab (TIS; anti-
PD-1) in combination with investigational agents
+/- chemotherapy as first-line treatment for
patients with locally advanced, unresectable, or
metastatic non-small cell lung cancer (NSCLC)
CT277
Tuesday, April 9
1:30 p.m. – 5 p.m. Section 50
Board #7
G. Blumenschein
About 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, 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 BeiGene’s ability to discover innovative new medicines for cancer patients and pioneer novel mechanisms; the future development, regulatory filing and approval, and commercialization of tislelizumab, BGB-16673, and other novel molecules; 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 annual report on Form 10-K, 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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Investor:
ir@beigene.com
Media:
media@beigene.com
Source: BeiGene, Ltd.
What data did BeiGene present at the AACR 2024 meeting?
BeiGene presented emerging oncology pipeline data, including tislelizumab combinations in solid tumors and preclinical characterization data for BGB-16673.
What is the significance of AdvanTIG-204 Phase 2 study results for tislelizumab plus ociperlimab?
The results are significant for first-line limited-stage small cell lung cancer (SCLC) and first-line non-small cell lung cancer (NSCLC) settings.
What was the outcome of the Phase 1a dose escalation study of BGB-10188 plus tislelizumab?
The study showed promising results in patients with solid tumors, indicating clinical responses and a tolerable safety profile.
What is the focus of the ongoing Phase 3 trial AdvanTIG-302?
The trial focuses on ociperlimab plus tislelizumab in stage IV, PD-L1 high NSCLC, with enrollment completion expected this month.
What are the key highlights of BGB-16673's Phase 1 study results in B-cell malignancies?
The results demonstrated clinical responses and tolerable safety in heavily pre-treated patients, including those with BTK inhibitor-resistant disease.
