BeOne Medicines reported the complete results of its Phase 3 HERIZON‑GEA‑01 study, a randomized trial evaluating the bispecific antibody ZIIHERA® (zanidatamab) in combination with chemotherapy, with or without the PD‑1 inhibitor TEVIMBRA® (tislelizumab), in first‑line HER2‑positive gastroesophageal adenocarcinoma.
The combination of ZIIHERA® plus TEVIMBRA® and chemotherapy met both primary endpoints. Progression‑free survival improved, with a median of 12.4 months versus 8.0 months in the control arm, and the risk of disease progression was reduced by 37%. Overall survival also surpassed the control, with a median of 26.4 months compared with 19.2 months, representing a 28% reduction in the risk of death (hazard ratio 0.72, P = 0.0043).
Safety data were consistent with the known toxicity profiles of HER2‑targeted therapy and PD‑1 inhibition. The most common grade 3 or higher adverse events were neutropenia, anemia, and diarrhea, occurring at rates comparable to those seen in prior trastuzumab‑based studies. No new safety signals were identified.
Mark Lanasa, M.D., Ph.D., Chief Medical Officer for Solid Tumors at BeOne, said the results “pave the way for a new standard of care in first‑line HER2‑positive metastatic gastroesophageal adenocarcinoma.” He added that the data support the company’s strategy to expand access in the Asia Pacific region, where the disease burden is highest. Manish Shah, M.D., Director of Gastrointestinal Oncology at Weill Cornell Medicine, noted that the median overall survival “surpasses two years, a significant advance in a disease with limited options.”
The findings position BeOne to pursue supplemental regulatory submissions in the United States and China. A successful approval would broaden the company’s solid‑tumor portfolio and unlock a sizable addressable market for HER2‑positive gastroesophageal cancers, a field that has historically offered limited therapeutic choices and a high unmet need. The trial’s success also strengthens BeOne’s competitive stance against other HER2‑targeted agents, such as trastuzumab deruxtecan, by demonstrating superior survival outcomes in a first‑line setting.
Gastroesophageal adenocarcinoma remains the fifth most common cancer worldwide, with a 5‑year survival rate below 30 %. Current standard therapy relies on trastuzumab plus chemotherapy, but the HERIZON‑GEA‑01 results suggest that a bispecific antibody combined with a PD‑1 inhibitor can deliver a meaningful survival benefit, potentially redefining the treatment paradigm for this aggressive disease.
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