BeOne Medicines has announced positive Phase 3 results from the HERIZON-GEA-01 trial, demonstrating that ZIIHERA (zanidatamab) in combination with TEVIMBRA (tislelizumab) and chemotherapy significantly improves progression-free survival (PFS) and overall survival (OS) in patients with first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The trial, which enrolled 914 patients across more than 30 countries, compared ZIIHERA plus chemotherapy, with or without TEVIMBRA, against the current standard of care, trastuzumab plus chemotherapy.
Both ZIIHERA plus TEVIMBRA and chemotherapy, and ZIIHERA plus chemotherapy, showed clinically meaningful and statistically significant improvements in PFS compared to the control arm. The ZIIHERA plus TEVIMBRA and chemotherapy combination also demonstrated a statistically significant improvement in OS, while the ZIIHERA plus chemotherapy arm showed a strong trend toward improved OS at the first analysis. These benefits were observed in both PD-L1 positive and PD-L1 negative subgroups, and both combination arms showed improved objective response rates and duration of response.
Dr. Sun Young Rha, Professor of Medical Oncology at Yonsei Cancer Center, highlighted the significance of these results, noting that advanced GEA remains a major global health challenge with poor outcomes. Mark Lanasa, Chief Medical Officer, Solid Tumors at BeOne, emphasized the potential of zanidatamab-based regimens to reshape clinical practice and expand access to effective therapies for patients in urgent need.
The safety profile of ZIIHERA in combination with chemotherapy, with or without TEVIMBRA, was consistent with the known profiles of each agent, with no new safety signals observed. These data will be presented at a major medical meeting in early 2026.
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