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BeOne Medicines Reports Sustained Survival Benefit with TEVIMBRA-ZIIHERA Combination in First-Line HER2+ Gastroesophageal Cancer

Business Wire

New data from HERIZON-GEA-01 Phase 3 trial show 36-month overall survival of nearly 40% with TEVIMBRA plus ZIIHERA and chemotherapy, and median OS reaching 27 months

TEVIMBRA-containing arm was associated with a four-month longer median OS compared with ZIIHERA plus chemotherapy

SAN CARLOS, Calif., October 23, 2026--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new survival results from the planned second interim analysis (IA2) and final formal analysis of the Phase 3 HERIZON-GEA-01 trial, further confirming the benefit of TEVIMBRA® (tislelizumab) plus ZIIHERA® (zanidatamab) and chemotherapy as first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The results will be presented today as a late-breaking abstract during a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (LBA79).

Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said:

"Following the U.S. approval in August, these longer-term data provide further evidence supporting TEVIMBRA plus ZIIHERA and chemotherapy as the new standard of care in all first-line HER2-positive advanced gastroesophageal adenocarcinoma patients, regardless of PD-L1 status. The magnitude of the survival benefit previously demonstrated with TEVIMBRA plus ZIIHERA and chemotherapy versus trastuzumab plus chemotherapy increased after longer follow-up, with nearly 40% of patients receiving the TEVIMBRA-containing regimen alive at three years, representing a compelling result in this challenging disease area."

Longer follow-up reinforces benefit of TEVIMBRA in combination regimen

This new analysis was conducted after 35.3 months of follow-up, an additional 9.4 months since the first interim analysis. Formal overall survival (OS) comparisons were tested sequentially, first comparing ZIIHERA plus chemotherapy with trastuzumab plus chemotherapy and then comparing TEVIMBRA plus ZIIHERA and chemotherapy with ZIIHERA plus chemotherapy.

Key findings include:

  • TEVIMBRA plus ZIIHERA and chemotherapy demonstrated sustained long-term survival versus trastuzumab plus chemotherapy. Median OS was 27.0 months, with an OS hazard ratio (HR) of 0.65 (95% CI: 0.52-0.80), improved from 0.72 at the first interim analysis. This regimen is the only treatment for patients with HER2+ GEA to show a median overall survival of more than two years.

  • ZIIHERA plus chemotherapy significantly improved OS versus trastuzumab plus chemotherapy. Median OS was 22.9 months versus 19.6 months, respectively (HR 0.76; 95% CI: 0.62-0.93; P=0.0088), meeting the remaining primary endpoint of the study.

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