BeOne has reported the Phase III HERIZON-GEA-01 trial met dual primary endpoints, the zanidatamab plus tislelizumab combination demonstrating statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to trastuzumab plus chemotherapy in 914 patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The HER2-targeted bispecific antibody (BsAb) combined with the PD-1 inhibitor showed clinical benefit across PD-L1-positive and -negative subgroups, with objective response rate (ORR) and duration of response (DOR) improvements supporting potential new first-line standard of care. Safety profiles remained consistent with those of individual agents, without new signals observed across treatment arms.

Zanidatamab originates from Canada's Zymeworks. An agreement granted Jazz Pharmaceuticals an ex-Asia commercialisation license, while BeOne holds rights for Asia excluding Japan and India following prior approval in biliary tract cancer. The trial represents the largest global study in HER2-positive gastroesophageal cancer, with high incidence across BeOne's key markets including China, where gastric cancer burden remains substantial. OS interim analysis for a zanidatamab monotherapy arm is planned mid-2026, with full data presentation scheduled for Q1 2026. These results support regulatory submissions for expanded indications in gastrointestinal malignancies with HER2 expression.

PharmCube's NextBiopharm® database shows that BeOne ranks 14 globally by number of oesophageal cancer projects. Click here to request a free trial for NextBiopharm®.