Jazz Pharmaceuticals plc announced positive Phase 3 trial results for Ziihera in combination with chemotherapy for HER2-positive gastroesophageal adenocarcinoma.
Ziihera showed significant improvements in progression-free survival and overall survival compared to the standard treatment of trastuzumab plus chemotherapy.
The company plans to submit a supplemental Biologics License Application for this indication in the first half of 2026.
Significant PFS Improvement
Ziihera plus chemotherapy demonstrated a statistically significant improvement in PFS versus trastuzumab and chemotherapy.
OS Benefits
Ziihera plus tislelizumab and chemotherapy showed significant improvements in OS compared to the standard treatment.
New Standard of Care
The results suggest that Ziihera could become the new standard of care for HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.
- The trial results indicate a potential shift in the treatment landscape for HER2-positive gastroesophageal adenocarcinoma, offering a more effective option than the current standard treatment.
- The safety profile of Ziihera in combination with chemotherapy was consistent with known safety profiles, supporting its overall benefit in this indication.
The positive Phase 3 results for Ziihera suggest a promising future as a potential new standard of care in the treatment of HER2-positive gastroesophageal adenocarcinoma.