New data from four priority programs, including the GPC3x4-1BB bispecific antibody, CEA targeting ADC, CDK4 inhibitor, and brain-penetrant PRMT5 inhibitor underscore the depth of BeOnes solid tumor pipeline
Multiple TEVIMBRA abstracts reinforce breadth of evidence across lung and gastrointestinal cancers, including data in combination with ZIIHERA in HER2+ gastroesophageal cancer
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that data from across its rapidly progressing solid tumor portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress 2026 on October 23-27 in Madrid. Presentations will highlight an accelerating pipeline of differentiated targeted therapies, alongside a broad body of evidence for TEVIMBRA (tislelizumab), including a late-breaking rapid oral presentation on TEVIMBRA in combination with ZIIHERA (zanidatamab) in HER2+ gastroesophageal adenocarcinoma (GEA). Priority pipeline data include an oral proffered paper presentation on BeOne's GPC3x4-1BB bispecific antibody, currently being studied in hepatocellular carcinoma (HCC) and first-in-human data for two investigational lung cancer assets, a CEA targeting antibody-drug conjugate (ADC), in CEA-expressing non-small cell lung cancer (NSCLC), and a brain-penetrant PRMT5 inhibitor in MTAP-deleted tumors, including NSCLC. A trial-in-progress (TiP) abstract of KANDELA-302 will be presented for the Company's CDK4 inhibitor, in front-line metastatic HR+/HER2-negative breast cancer (BC).
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said:
"2026 has been an inflection year for our solid tumor portfolio. Across major medical congresses, we have demonstrated proof of concept for five priority programs, while rapidly advancing these assets toward pivotal development. At ESMO, that progress is visible in pipeline data spanning our three strategically focused disease areas, breast, lung, and gastrointestinal cancers, alongside further evidence supporting TEVIMBRA, including updated Phase 3 data in combination with ZIIHERA in HER2+ gastroesophageal adenocarcinoma. Together, the reach of TEVIMBRA and a pipeline advancing at scale position BeOne to change the game in solid tumor oncology."
Pipeline at scale: advancing priority programs with new data at ESMO
The latest evidence of the progress of BeOne's solid tumor pipeline will be presented at ESMO with abstracts being published across four investigational assets, demonstrating the speed and scale of BeOne's global development superhighway.
Priority pipeline presentations at ESMO include:
- BGB-B2033 (GPC3x4-1BB bispecific antibody): An oral proffered paper presentation with updated Phase 1 dose-escalation and first dose-optimization results in previously treated patients with advanced HCC.
- BG-C477 (CEA targeting ADC): First-in-human Phase 1 data in heavily pretreated, locally advanced NSCLC, with further analysis provided in patients with CEA-high expressing tumors.
- BGB-58067 (PRMT5 inhibitor): First-in-human data evaluating BeOne's brain-penetrant, MTA-cooperative PRMT5 inhibitor in MTAP-deficient advanced tumors.
- BGB-43395 (CDK4 inhibitor): Trial-in-progress presentation of KANDELA-302, a global Phase 3 study evaluating BGB-43395 plus letrozole compared with investigator's choice of a CDK4/6 inhibitor plus letrozole as first-line treatment for advanced or metastatic HR+/HER2-negative BC.
Strengthening evidence base for TEVIMBRA in lung and gastrointestinal cancers
In addition to pipeline data, seven abstracts at ESMO will further characterize TEVIMBRA across lung and gastrointestinal cancers, including a late-breaking, rapid oral presentation with new data from the Phase 3 HERIZON-GEA-01 trial in HER2+ gastroesophageal adenocarcinoma.
Key TEVIMBRA presentations include:
- HERIZON-GEA-01: Second interim analysis of the Phase 3 trial of ZIIHERA plus chemotherapy, with and without TEVIMBRA, in first-line HER2-positive locally advanced or metastatic GEA.
- RATIONALE-312: Exploratory analysis evaluating the effect of TEVIMBRA plus platinum-etoposide on brain disease progression in first-line extensive stage small-cell lung cancer (ES-SCLC).
- RATIONALE-315: Analysis of clinical outcomes by adjuvant treatment cycles with perioperative TEVIMBRA plus chemotherapy in patients with resectable NSCLC.
- RATIONALE-305 and RATIONALE-302: New analyses further evaluating outcomes with TEVIMBRA in gastric/gastroesophageal junction (GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC), respectively.
Full list of BeOne's presentations at ESMO:
Pipeline data
Abstract Title | Presentation Details (CET) | Lead
|
Phase 1 study of BGB-B2033 monotherapy: First disclosure of dose optimization and dose escalation update in advanced HCC | Proffered paper 1679O;Gastrointestinal tumour, upper digestive; Oct. 24, 10:15-11:45AM | Hong Jae Chon |
First-in-human study of BG-C477, a novel CEA-targeting ADC, in advanced solid tumors: initial results in NSCLC | Poster: 2567P; NSCLC, locally advanced; Oct. 26, 12:00-12:45 | Matthew Lee |
First-in-human trial of BGB-58067, an MTA-cooperative PRMT5 inhibitor, in MTAP-deficient advanced tumors | Poster: 1043P; Translational Research and Biomarkers; Oct. 23, 3:15-4:00 PM | Jordi Rodon |
KANDELA-302: A Phase 3, global, open-label, randomized study of the selective CDK4 inhibitor BGB-43395 letrozole vs CDK4/6 inhibitors letrozole for first-line treatment of advanced or metastatic HR+/HER2- breast cancer | Poster: 1885TiP; HR+ Breast Cancer; Oct. 24, 12:00-12:45 | Sara M. Tolaney |
TEVIMBRA data
Abstract Title | Presentation Details (CET) | Lead
|
Zanidatamab chemotherapy tislelizumab for first-line HER2+ advanced/metastatic GEA: second interim analysis from HERIZON-GEA-01 | Rapid oral: LBA79; Gastrointestinal tumour, upper digestiveOct 23, 4:15-5:45 PM | Kohei Shitara |
Phase 1b/2 trial of BGB-A445 (OX40 agonist) with or without tislelizumab in urothelial carcinoma, renal cell carcinoma, and melanoma | Poster: 1980P; Investigational Immunotherapy; Oct. 24, 12:00-12:45 | Bin Lian |
Impact of progressive disease patterns on post-progression overall survival in ESCC: A post hoc analysis of RATIONALE-302 | Poster: 2950P; Oesophagogastric cancer; Oct. 25, 12:00-12:45 | Jhe-Cyuan Guo |
RATIONALE-305: Post-treatment immuno-oncology adjustment analysis to assess tislelizumab treatment effect vs placebo | Poster: 2931P; Oesophagogastric cancer; Oct. 25, 12:00-12:45 | Markus Moehler |
RATIONALE-312: Exploratory analysis of tislelizumab plus platinum-etoposide on brain disease progression in first-line ES-SCLC | Poster: 3839P; SCLC; Oct. 26, 12:00-12:45 | Francesco Passiglia |
RATIONALE-315: Clinical outcomes by adjuvant treatment cycles in perioperative tislelizumab plus chemotherapy in resectable NSCLC | Poster: 2594P; NSCLC, locally advanced; Oct. 26, 12:00-12:45 | Ernest Nadal |
Exposure-adjusted analyses of safety patterns in HERIZON-GEA-01: Zanidatamab with and without tislelizumab and chemotherapy in 1L HER2+ metastatic GEA | Poster: 2946P; Oesophagogastric cancer; Oct. 25, 12:00-12:45 | Sun Young Rha |
About ZIIHERA (zanidatamab-hrii)
ZIIHERA (zanidatamab-hrii) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.
ZIIHERA is a registered trademark of Zymeworks BC Inc.
About TEVIMBRA (tislelizumab)
TEVIMBRA 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 (Fc?) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors.
TEVIMBRA is the cornerstone asset of BeOne's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved for various solid tumors (see prescribing information) in over 50 countries, and more than 2.2 million patients have been treated globally.
Important Safety Information
The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.
The information in this press release is intended for a global audience. Product indications vary by region.
About BeOne
BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.
Forward-Looking Statement
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 advancement of BeOne's solid tumor pipeline toward pivotal development; the potential of TEVIMBRA across multiple tumor types and disease settings; and BeOne's plans, commitments, aspirations, and goals under the heading "About BeOne." Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne'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; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne'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 BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne'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 BeOne undertakes no duty to update such information unless required by law.
To access BeOne media resources, please visit ourNewsroomsite.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
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