Zymeworks Reports Positive Phase 3 Results for Ziihera in HER2-Positive Gastroesophageal Cancer
Reuters
Nov 17, 2025
Zymeworks Reports Positive Phase 3 Results for Ziihera in HER2-Positive Gastroesophageal Cancer
Zymeworks Inc. has announced positive topline results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera® (zanidatamab-hrii) in combination with chemotherapy, with or without the PD-1 inhibitor Tevimbra® (tislelizumab), as a first-line treatment for HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. The trial results showed that Ziihera plus chemotherapy demonstrated a clinically meaningful and statistically significant improvement in progression-free survival compared to trastuzumab and chemotherapy, with a strong trend toward statistically significant overall survival improvement at the first interim analysis. The combination of Ziihera, Tevimbra, and chemotherapy also showed statistically significant improvements in both overall and progression-free survival compared to the control group. Jazz Pharmaceuticals, the development and commercialization partner of Zymeworks, plans to submit these data for presentation at a major medical meeting in the first quarter of 2026 and for publication in a peer-reviewed journal. A supplemental Biologics License Application is expected to be submitted in the first half of 2026.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Zymeworks Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9576772-en) on November 17, 2025, and is solely responsible for the information contained therein.
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