BeOne Medicines Advances Solid Tumor Oncology Pipeline With New Data Across Breast, Lung and Gastrointestinal Cancers at ESMO 2026
BeOne Medicines Ltd., a global oncology company, announced that it will present new clinical data from its rapidly advancing solid tumor portfolio at the European Society for Medical Oncology (ESMO) Congress 2026, scheduled for October 23–27 in Madrid, Spain. The presentations will showcase progress across the company’s targeted therapy pipeline and provide additional evidence supporting TEVIMBRA® (tislelizumab), its anti-PD-1 immunotherapy, across multiple cancer types.
The congress will feature a broad range of research covering BeOne’s strategically prioritized disease areas, including breast, lung and gastrointestinal cancers. Among the highlights will be a late-breaking rapid oral presentation featuring TEVIMBRA in combination with ZIIHERA® (zanidatamab) for HER2-positive gastroesophageal adenocarcinoma (GEA). The presentation will provide updated findings from the Phase 3 HERIZON-GEA-01 clinical trial, which is evaluating treatment combinations in patients with locally advanced or metastatic disease.
BeOne will also present new data from several investigational therapies designed to address significant unmet medical needs in oncology. These include BGB-B2033, a GPC3x4-1BB bispecific antibody being investigated in hepatocellular carcinoma (HCC); BG-C477, a carcinoembryonic antigen (CEA)-targeting antibody-drug conjugate (ADC) for CEA-expressing non-small cell lung cancer (NSCLC); and BGB-58067, a brain-penetrant protein arginine methyltransferase 5 (PRMT5) inhibitor being studied in tumors with methylthioadenosine phosphorylase (MTAP) deletion.
The company will additionally share a trial-in-progress abstract for KANDELA-302, a global Phase 3 study evaluating BGB-43395, its investigational cyclin-dependent kinase 4 (CDK4) inhibitor, in combination with letrozole as a potential first-line treatment for advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer.
Together, the presentations reflect BeOne’s strategy of advancing a differentiated oncology pipeline while continuing to expand the clinical evidence supporting its established and investigational therapies.
BeOne Highlights Progress Across Its Solid Tumor Portfolio
The ESMO 2026 presentations represent another milestone in BeOne’s efforts to accelerate the development of innovative treatments for patients with solid tumors. The company is focusing its research and development activities on breast, lung and gastrointestinal cancers, with programs spanning targeted therapies, immunotherapy combinations and investigational agents designed to address specific molecular characteristics of tumors.
According to BeOne, 2026 has been an important year for its solid tumor portfolio, with five priority programs demonstrating proof of concept across major medical congresses and moving toward further clinical development. The new ESMO data will build on this progress by providing additional information about the activity and development potential of selected investigational candidates.
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, emphasized the importance of the company’s expanding pipeline and the role of its clinical development strategy in advancing potential cancer treatments.
“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,” Lanasa said.
The upcoming presentations will provide researchers and oncology professionals with opportunities to evaluate findings across different therapeutic approaches and disease settings. The data will also help illustrate how BeOne is building a portfolio that combines immunotherapy with precision-targeted treatments for cancers characterized by distinct biological features.
Priority Investigational Programs to Feature New Clinical Data
Four investigational assets will be highlighted through presentations at ESMO 2026. The data will cover early-stage clinical research, dose optimization and the design of a pivotal-stage clinical study.
BGB-B2033: Advancing a GPC3x4-1BB Bispecific Antibody for Liver Cancer
BeOne will deliver an oral proffered paper presentation featuring updated Phase 1 dose-escalation findings and initial dose-optimization results for BGB-B2033 in patients with previously treated advanced hepatocellular carcinoma.
HCC is the most common form of primary liver cancer and represents a significant challenge in oncology, particularly for patients whose disease has progressed following previous treatment. Developing new therapies that can selectively target cancer-associated biological pathways remains an important area of investigation.
BGB-B2033 is a bispecific antibody designed to target glypican 3 (GPC3) and engage the 4-1BB immune costimulatory receptor. GPC3 is a protein expressed in various cancers, including many cases of HCC, making it a potential target for tumor-directed therapeutic strategies.
The candidate’s dual-targeting approach is intended to combine recognition of GPC3-expressing tumor cells with stimulation of immune activity through 4-1BB. By bringing these mechanisms together, the investigational therapy seeks to support an immune response directed toward malignant cells.
The ESMO presentation will provide updated information from the Phase 1 dose-escalation portion of the study, together with the first results from dose optimization. These findings are expected to contribute to the ongoing evaluation of the candidate’s clinical profile and help inform decisions about its further development.
As the program progresses, additional clinical investigation will be important to establish the therapy’s safety, tolerability, potential antitumor activity and appropriate dosing strategy.
BG-C477: First-in-Human Data for a CEA-Targeting ADC in Lung Cancer
BeOne will also present first-in-human Phase 1 data for BG-C477, an investigational antibody-drug conjugate targeting carcinoembryonic antigen (CEA).
The presentation will focus on patients with heavily pretreated, locally advanced NSCLC, with additional analysis among patients whose tumors demonstrate high CEA expression.
CEA is a tumor-associated antigen that can be expressed at elevated levels in certain cancers. Antibody-drug conjugates are designed to combine the targeting capabilities of an antibody with a linked therapeutic payload. This approach aims to deliver an anticancer agent to cells expressing the selected target, although the clinical benefits and safety profile of each ADC must be established through clinical testing.
For patients with advanced NSCLC who have already received multiple treatments, additional therapeutic options remain an important clinical need. Treatment selection can be influenced by tumor characteristics, previous therapies, disease progression and patient-specific factors.
The first-in-human data for BG-C477 will contribute to the early assessment of this candidate in lung cancer. The planned analysis of patients with CEA-high tumors will also provide information relevant to understanding the relationship between target expression and treatment outcomes.
As an early-stage investigational program, BG-C477 will require further study to determine its efficacy, safety, tolerability and potential role in the treatment landscape for CEA-expressing tumors.
BGB-58067: Investigating a Brain-Penetrant PRMT5 Inhibitor
Another key presentation will feature first-in-human clinical data for BGB-58067, BeOne’s investigational brain-penetrant, MTA-cooperative PRMT5 inhibitor.
The candidate is being evaluated in patients with advanced tumors characterized by MTAP deficiency. MTAP deletion is a molecular alteration found in a subset of cancers and can create biological vulnerabilities that researchers are investigating as potential therapeutic targets.
PRMT5, or protein arginine methyltransferase 5, is an enzyme involved in cellular processes that include RNA processing, gene regulation and protein function. Alterations in the pathways regulated by PRMT5 may contribute to tumor growth and survival in certain molecular contexts.
The MTA-cooperative approach is intended to exploit the biological changes associated with MTAP loss. Because MTAP-deficient tumors can accumulate methylthioadenosine (MTA), researchers are investigating whether this condition can be used to selectively target cancer cells through PRMT5 inhibition.
BGB-58067 is also designed to penetrate the brain, a characteristic that may be relevant when evaluating its potential in cancers affecting the central nervous system. However, the clinical implications of this property will depend on the results of ongoing research.
The ESMO presentation will provide early clinical evidence from the first-in-human evaluation of the candidate in patients with advanced MTAP-deficient tumors, including NSCLC. These findings will help inform further investigation of the therapy’s pharmacological characteristics, safety and potential antitumor activity.
BGB-43395: Advancing a CDK4 Inhibitor for Breast Cancer
BeOne will present a trial-in-progress abstract for KANDELA-302, a global Phase 3 clinical study evaluating BGB-43395 in patients with advanced or metastatic HR-positive/HER2-negative breast cancer.
BGB-43395 is an investigational CDK4 inhibitor being developed for use in combination with letrozole. The Phase 3 study will compare this combination with investigator’s choice of a CDK4/6 inhibitor plus letrozole as first-line treatment.
HR-positive/HER2-negative breast cancer is a major disease subtype in which hormone signaling plays an important role in cancer growth. Endocrine therapies such as letrozole are commonly used to suppress estrogen production, while cyclin-dependent kinase inhibitors are used in appropriate treatment settings to interfere with cell-cycle progression.
CDK4 is involved in regulating the transition of cells from one stage of the cell cycle to another. Inhibiting this pathway may help restrict the proliferation of cancer cells, particularly when used alongside endocrine therapy.
KANDELA-302 will evaluate whether combining the investigational CDK4 inhibitor with letrozole can offer a clinically meaningful treatment option compared with an established treatment approach involving a CDK4/6 inhibitor and letrozole.
As a trial-in-progress presentation, the abstract will describe the study and its clinical development framework rather than provide a definitive assessment of treatment efficacy. The Phase 3 investigation will be important in establishing whether BGB-43395 can demonstrate an appropriate benefit-risk profile in the first-line setting.
TEVIMBRA Evidence Expands Across Lung and Gastrointestinal Cancers
Alongside its investigational pipeline, BeOne will present seven abstracts examining TEVIMBRA across lung and gastrointestinal cancers.
TEVIMBRA, also known as tislelizumab, is an anti-PD-1 monoclonal antibody developed to support the immune system’s ability to recognize and attack cancer cells. The treatment is being evaluated across multiple tumor types and treatment combinations, with the ESMO presentations intended to provide additional insight into its clinical performance in different disease settings.
One of the major highlights will be a late-breaking rapid oral presentation featuring updated results from the Phase 3 HERIZON-GEA-01 trial. The study is evaluating ZIIHERA, also known as zanidatamab, in combination with chemotherapy, with or without TEVIMBRA, as first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.
HER2-positive gastroesophageal cancers represent a distinct patient population in which HER2-directed treatment strategies may be relevant. The combination approach being investigated in HERIZON-GEA-01 brings together HER2-targeted therapy, chemotherapy and immune checkpoint inhibition.
The second interim analysis will provide additional information about the investigational treatment combinations. The presentation is expected to be of particular interest because it examines the potential contribution of adding TEVIMBRA to a regimen containing ZIIHERA and chemotherapy.
The findings will contribute to the broader evaluation of treatment strategies for patients with advanced HER2-positive gastroesophageal adenocarcinoma. The clinical significance of the results will depend on the reported efficacy, safety and other relevant study outcomes.
Additional TEVIMBRA Research in Lung Cancer
Several ESMO presentations will examine TEVIMBRA in lung cancer, including small-cell lung cancer and resectable NSCLC.
The RATIONALE-312 study will feature an exploratory analysis evaluating the effect of TEVIMBRA combined with platinum-etoposide chemotherapy on brain disease progression in patients receiving first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC).
ES-SCLC is an aggressive form of lung cancer that can spread rapidly and is frequently associated with substantial treatment challenges. Brain involvement is an important consideration in this disease, making the evaluation of treatment effects on brain disease progression clinically relevant.
The exploratory analysis will examine outcomes associated with the TEVIMBRA and chemotherapy combination. Such analyses may help researchers better understand patterns of disease progression and identify questions for further investigation.
Another presentation will examine results from RATIONALE-315, focusing on clinical outcomes according to the number of adjuvant treatment cycles received by patients with resectable NSCLC who were treated with perioperative TEVIMBRA plus chemotherapy.
Perioperative treatment approaches seek to address cancer before and after surgery, with the aim of improving disease control in selected patients. Evaluating outcomes according to adjuvant treatment cycles can help researchers investigate how treatment exposure relates to clinical outcomes, while accounting for the limitations inherent in exploratory analyses.
The RATIONALE-315 findings will add to the growing body of evidence on the use of immunotherapy in the management of resectable lung cancer.
Further Analyses in Gastric and Esophageal Cancers
BeOne will also present additional analyses from RATIONALE-305 and RATIONALE-302, extending the investigation of TEVIMBRA in gastrointestinal malignancies.
RATIONALE-305 focuses on gastric and gastroesophageal junction (GEJ) adenocarcinoma, while RATIONALE-302 evaluates TEVIMBRA in esophageal squamous cell carcinoma (ESCC).
These cancers represent important areas of oncology research because treatment selection can depend on tumor location, histology, disease stage, molecular characteristics and previous treatment exposure. Further analyses of clinical trial data can help researchers characterize patient outcomes and better understand the potential role of immunotherapy across different gastrointestinal cancer populations.
The additional findings from RATIONALE-305 and RATIONALE-302 will complement the HERIZON-GEA-01 results and other TEVIMBRA presentations at the congress. Together, the studies illustrate BeOne’s continued evaluation of immunotherapy across multiple gastrointestinal cancer settings.
ESMO 2026 Highlights BeOne’s Integrated Oncology Strategy
BeOne’s presence at ESMO 2026 reflects a dual strategy: strengthening the evidence base for TEVIMBRA while advancing a pipeline of investigational therapies directed at specific tumor targets and molecular vulnerabilities.
The four highlighted pipeline programs address different areas of unmet medical need. BGB-B2033 is being studied through a dual-targeting immunotherapy approach in HCC; BG-C477 applies ADC technology to CEA-expressing lung cancer; BGB-58067 investigates a molecular vulnerability associated with MTAP-deficient tumors; and BGB-43395 is being advanced through a global Phase 3 study in HR-positive/HER2-negative breast cancer.
At the same time, the TEVIMBRA presentations will examine its use in combination regimens and across several lung and gastrointestinal cancer settings. The late-breaking HERIZON-GEA-01 data will be a central feature of the company’s congress program.
Although the investigational candidates remain subject to ongoing clinical evaluation, the breadth of the planned presentations demonstrates the scale of BeOne’s solid tumor development efforts. The findings may help guide subsequent research, clarify the potential of emerging treatment approaches and support decisions about the next stages of clinical development.
The ESMO Congress 2026, taking place October 23–27 in Madrid, will provide a platform for BeOne to share these findings with the international oncology community. Through its expanding portfolio of targeted therapies and continued investigation of TEVIMBRA, the company aims to develop new treatment options for patients across breast, lung and gastrointestinal cancers.
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 (Fcγ) 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.