BeOne Reports New Phase 3 Survival Data for ZIIHERA

San Carlos, Calif. – August 31, 2026

BeOne Highlights Overall Survival Benefit With ZIIHERA

The most important development from the HERIZON-GEA-01 Phase 3 trial is confirmation that the ZIIHERA plus chemotherapy regimen achieved its remaining primary endpoint of overall survival at the second interim analysis. The result adds to earlier findings from the first interim analysis, which established progression-free survival and overall survival benefits for the TEVIMBRA plus ZIIHERA and chemotherapy regimen. BeOne reported that the overall survival benefit remained evident across PD-L1 and HER2 expression levels, supporting the potential applicability of the treatment approach across clinically relevant patient groups. The latest analysis also showed continued durable outcomes for patients receiving the immunotherapy-containing regimen, while the safety profile remained generally consistent with the earlier analysis and the known safety profiles of the individual therapies. No new safety signals were identified at IA2. The results are particularly relevant in first-line HER2-positive GEA, where treatment decisions can significantly influence long-term disease control and survival outcomes.

HERIZON-GEA-01 Evaluates ZIIHERA-Based First-Line Treatment

HERIZON-GEA-01 randomized 914 patients across approximately 300 sites in more than 30 countries, making it a large global Phase 3 evaluation of first-line treatment strategies for advanced or metastatic HER2-positive GEA. Participants were assigned to one of three treatment groups: ZIIHERA plus chemotherapy and TEVIMBRA, ZIIHERA plus chemotherapy, or standard treatment with trastuzumab plus chemotherapy. The study included patients with unresectable locally advanced, recurrent or metastatic adenocarcinoma of the stomach, esophagus or gastroesophageal junction with centrally confirmed HER2 positivity. The trial’s dual primary endpoints were progression-free survival and overall survival. The new IA2 findings build on the earlier efficacy results and provide additional evidence for the potential role of ZIIHERA-based treatment in the first-line setting. BeOne said the results from IA2 have been submitted for presentation at a major medical meeting expected during the fourth quarter of 2026, potentially providing additional detail on the survival findings and longer-term treatment outcomes.

BeOne Builds Momentum Following Recent FDA Approval

The new Phase 3 survival findings arrive shortly after a major regulatory milestone for ZIIHERA and TEVIMBRA. On August 25, 2026, the U.S. FDA approved supplemental biologics license applications for both medicines in combination with chemotherapy for first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma. The approval was supported by the earlier IA1 results and established the regimen as the first FDA-approved immunotherapy-based treatment in this setting with median overall survival exceeding two years regardless of PD-L1 status. ZIIHERA is a HER2-directed bispecific antibody designed to bind two extracellular sites on HER2, while TEVIMBRA is a PD-1 inhibitor designed to enhance immune-mediated tumor control. With the latest IA2 results confirming statistically significant overall survival benefit for both experimental treatment strategies, BeOne is strengthening the clinical and regulatory foundation of its oncology portfolio while advancing broader development of ZIIHERA across HER2-expressing solid tumors.

Source:BeOne Medicines,press relese