BeOne Medicines Announces New Phase 3 Survival Data Reinforcing Benefit of ZIIHERA-Containing Regimens in First-Line HER2+ Gastroesophageal Cancer
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.
