Jazz Pharmaceuticals announced that the Phase 3 HERIZON‑GEA‑01 trial met its primary endpoint, showing a statistically significant improvement in progression‑free survival for patients treated with Ziihera (zanidatamab‑hrii) plus standard chemotherapy versus trastuzumab plus chemotherapy. The study enrolled 914 patients across more than 30 countries and demonstrated a strong overall‑survival trend, higher objective‑response rates, and longer duration of response. Safety data were consistent with the known profile of bispecific HER2 antibodies, with no new safety signals identified.
The trial also evaluated Ziihera in combination with the PD‑1 inhibitor Tevimbra (tislelizumab) and chemotherapy. The dual‑modality arm produced similar efficacy benefits, suggesting that adding Tevimbra does not compromise safety while potentially enhancing antitumor activity. This finding supports a flexible treatment approach that could be tailored to patient preferences and biomarker status.
These results position Ziihera as a potential new first‑line standard of care for HER2‑positive gastroesophageal adenocarcinoma, a disease that accounts for roughly 20 % of the fifth‑most common cancer worldwide. Analysts project peak sales of more than $2 billion if the drug gains regulatory approval, and the partnership with Zymeworks could unlock up to $1.36 billion in milestones for Jazz. The data also reinforce Jazz’s broader oncology strategy, which has focused on expanding its portfolio through acquisitions and pipeline development.
Jazz plans to submit a supplemental Biologics License Application in the United States in the first half of 2026, a timeline that aligns with the company’s broader regulatory roadmap for oncology assets. The sBLA will seek approval for Ziihera as a first‑line therapy for HER2‑positive locally advanced or metastatic disease, with or without Tevimbra, in combination with standard chemotherapy.
Financially, Jazz reported Q3 2025 revenues of $1.126 billion, up from $1.055 billion a year earlier, and Q4 2024 revenues of $1.1 billion, exceeding expectations. The company’s strong cash position and consistent revenue growth provide a solid foundation for future investment in commercialization and additional clinical development.
Rob Iannone, Executive Vice President and Chief Medical Officer, emphasized that the data “will be practice‑changing” and highlighted the potential impact of Ziihera for patients facing a devastating diagnosis. CEO Renee Gala noted that Jazz remains confident in the opportunity presented by zanidatamab and is eager to share the top‑line data before year‑end.
Ziihera is already approved in the United States, Europe, and China for second‑line biliary tract cancer, underscoring its versatility as a bispecific HER2 antibody. The new GEA data expand its indication to a larger patient population and demonstrate the drug’s ability to deliver meaningful clinical benefit in a high‑volume first‑line setting.
In summary, the positive Phase 3 results for Ziihera represent a pivotal milestone for Jazz’s oncology portfolio, offering a new therapeutic option for a disease with significant unmet need and positioning the company for substantial revenue growth if regulatory approval is obtained.
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