Positive Phase 3 results for Ziihera: significant PFS/OS improvement in first-line HER2+ GEA

Jazz Pharmaceuticals plc

Ziihera + chemo showed statistically significant PFS improvement vs trastuzumab + chemo; OS clinically meaningful trend at first interim analysis.
Ziihera + tislelizumab + chemo showed statistically significant OS and PFS improvements vs control.
Benefit observed in both PD-L1 positive and negative subgroups; improvements in ORR and DoR.
Company plans to submit sBLA in first half of 2026; data to be presented at medical meeting Q1 2026.

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