Phase 3 Finds Ziihera Triplet Improves Survival Over Trastuzumab in First-Line HER2+ GEA
Jazz targets a first‑half 2026 sBLA after topline results reported no new safety issues.
Overview
- HERIZON-GEA-01 showed Ziihera plus chemotherapy significantly improved progression-free survival versus trastuzumab plus chemotherapy, with overall survival trending toward significance at the first analysis.
- Ziihera with Tevimbra and chemotherapy delivered statistically significant, clinically meaningful gains in overall survival and progression-free survival versus the control regimen.
- Efficacy for the triplet regimen was observed in both PD-L1–positive and PD-L1–negative subgroups.
- Safety for Ziihera combinations was consistent with known profiles with no new safety signals identified.
- Jazz plans to present full data in Q1 2026, pursue NCCN guideline inclusion, file an sBLA in the first half of 2026, and conduct another overall survival interim analysis for the doublet arm in mid‑2026.