Jazz Pharmaceuticals presented groundbreaking long-term survival data for Ziihera at the ASCO 2025 Annual Meeting, highlighting its potential in treating HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA).
Phase 2 Trial Yields Promising Outcomes
In a Phase 2 study involving 46 patients from the US, Canada, and South Korea, Ziihera combined with chemotherapy achieved a median overall survival (OS) of 36.5 months after four years. Specifically, among 41 patients with confirmed HER2-positive tumors, the median progression-free survival (PFS) reached 15.2 months. These results notably exceed the standard median survival rates of 15 to 20 months typically seen with existing treatments.
Safety and Future Research
The long-term follow-up indicated a manageable safety profile, with common adverse effects including diarrhea and hypokalemia. Importantly, no new safety concerns emerged, and discontinuation rates remained low. Building on these findings, Jazz Pharmaceuticals is advancing to the Phase 3 HERIZON-GEA-01 trial, with top-line results expected in late 2025.
- Ziihera demonstrates sustained antitumor activity over an extended period.
- Enhanced median OS suggests significant clinical benefits for mGEA patients.
- Low discontinuation rates reflect the drug’s tolerability and safety.
The extended survival benefits observed in the Phase 2 trial position Ziihera as a leading candidate for first-line therapy in HER2-positive mGEA. With a median OS of 36.5 months, patients may experience substantially improved outcomes compared to existing treatment options. The favorable safety profile further supports its potential widespread use, addressing a critical need in a cancer type with historically poor prognosis. As Jazz Pharmaceuticals moves forward with Phase 3 trials, the medical community remains optimistic about Ziihera’s ability to redefine treatment standards and enhance patient quality of life in the face of aggressive gastroesophageal adenocarcinoma.
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