BeOne Medicines announced that its Phase 3 HERIZON‑GEA‑01 study met its primary and key secondary endpoints, showing that the bispecific antibody ZIIHERA (zanidatamab) combined with standard chemotherapy, with or without the PD‑1 inhibitor TEVIMBRA (tislelizumab), produced statistically significant improvements in progression‑free survival (PFS) and overall survival (OS) compared with the control arm of trastuzumab plus chemotherapy.
The trial demonstrated a clear benefit for the triple‑combination arm, with the most pronounced OS advantage, while the ZIIHERA‑plus‑chemotherapy arm also showed a strong trend toward OS improvement. Although the exact hazard ratios and median survival times were not disclosed, the study reported p‑values well below the conventional 0.05 threshold, underscoring the robustness of the findings.
These results position ZIIHERA as a potential new standard of care for first‑line treatment of HER2‑positive gastroesophageal adenocarcinoma, a disease with historically limited therapeutic options. The data expand BeOne’s oncology portfolio beyond its flagship BTK inhibitor BRUKINSA and support Jazz Pharmaceuticals’ plan to file a supplemental Biologics License Application in the first half of 2026, potentially accelerating market access.
"The positive results of this trial demonstrate that zanidatamab‑based combination regimens have the potential to reshape clinical practice for the first‑line treatment of HER2‑positive metastatic gastroesophageal disease," said Dr. Sun Young Rha, investigator on the HERIZON‑GEA‑01 study. "These findings give us confidence that we are on the right path to delivering a meaningful benefit to patients in a high‑unmet‑need area," added Mark Lanasa, Chief Medical Officer of Solid Tumors at BeOne. Rob Iannone, Executive Vice President and Chief Medical Officer of Jazz Pharmaceuticals, noted that the data "highlight the potential impact of ZIIHERA for patients facing a devastating diagnosis and limited options."
BeOne’s stock rose 4.2% on the day of the announcement, reflecting investor enthusiasm for the statistically significant PFS and OS gains and the prospect of a new standard of care. The market reaction was driven primarily by the clear clinical benefit demonstrated in the trial and the strategic implications for BeOne’s oncology pipeline and Jazz’s regulatory strategy.
The company will now focus on regulatory submissions and further clinical development, with the goal of securing approval for ZIIHERA in this indication. The positive Phase 3 data strengthen BeOne’s competitive position and support expectations of substantial future revenue growth as the drug moves closer to market availability.
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