• Findings provide further evidence of overall survival benefit of TEVIMBRA plus ZIIHERA and chemotherapy regimen in HER2+ GEA
• ZIIHERA plus chemotherapy demonstrated statistically significant overall survival benefit at second interim analysis of HERIZON-GEA-01 trial

BeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235))), a global oncology company, today announced positive topline results from the second interim analysis (IA2) of the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), in combination with chemotherapy, with and without TEVIMBRA® (tislelizumab), as first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). At IA2, ZIIHERA plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared with trastuzumab plus chemotherapy, meeting the remaining primary endpoint analysis of the study.

IA2 also provided longer follow-up data for the TEVIMBRA plus ZIIHERA and chemotherapy regimen, demonstrating an improved OS hazard ratio, continued durable outcomes, and a generally manageable safety profile. These results reinforce findings from IA1, in which the regimen met the progression-free survival (PFS) and OS endpoints, with the overall survival benefit observed across PD-L1 and HER2+ expression levels.

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