Overview
- Topline results from HERIZON-GEA-01 show Ziihera plus chemotherapy and Ziihera plus Tevimbra plus chemotherapy both delivered statistically significant, clinically meaningful progression-free survival gains versus trastuzumab plus chemotherapy.
- The triple regimen with Tevimbra achieved a statistically significant overall survival improvement, while the chemotherapy-only Ziihera arm showed a clinically meaningful effect with a strong trend toward significance pending a planned mid-2026 OS interim analysis.
- Efficacy for the triple regimen was observed in both PD-L1–positive and PD-L1–negative subgroups, and both Ziihera arms improved objective response rate and duration of response compared with control.
- Companies reported safety as consistent with known profiles for the agents and said no new safety signals emerged in the study.
- Jazz plans to present full data at a major medical meeting in Q1 2026 and submit a supplemental BLA in the first half of 2026; shares of Zymeworks and Jazz rose roughly 29% and about 20% respectively, with BeOne also higher on the news.