Overview
- Ziihera plus chemotherapy delivered a statistically significant improvement in progression‑free survival over trastuzumab plus chemotherapy in first‑line HER2‑positive gastroesophageal adenocarcinoma.
- The Ziihera, Tevimbra and chemotherapy arm achieved statistically significant gains in overall survival and progression‑free survival versus control, with benefits seen in both PD‑L1‑positive and PD‑L1‑negative subgroups.
- Ziihera plus chemotherapy showed a clinically meaningful overall survival effect with a strong trend toward significance at the first analysis, with another interim OS readout planned for mid‑2026.
- Both Ziihera regimens improved objective response rate and duration of response, and the safety profile was consistent with known risks without new signals.
- Jazz plans a Q1 2026 data presentation, peer‑reviewed publication and NCCN guideline submission, and expects to file a supplemental BLA in the first half of 2026 as Zymeworks, Jazz and BeOne shares rose on the news.