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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 BeOne
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s solid tumor pipeline
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Multiple TEVIMBRA abstracts reinforce breadth of evidence across lung and gastrointestinal cancers, including data in combination with ZIIHERA in HER2+ gastroesophageal cancer
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SAN CARLOS, Calif. — 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).
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Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said:
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“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.”
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Pipeline at scale: advancing priority programs with new data at ESMO
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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.
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Priority pipeline presentations at ESMO include:
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- 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.
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Strengthening evidence base for TEVIMBRA in lung and gastrointestinal cancers
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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.
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Key TEVIMBRA presentations include:
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- 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.
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Full list of BeOne’s presentations at ESMO:
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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 |
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TEVIMBRA data
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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 digestive Oct 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 |
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