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Investing.com -- Zymeworks Inc. (NASDAQ:ZYME) stock surged 57% after announcing positive topline results from its Phase 3 HERIZON-GEA-01 trial evaluating Ziihera (zanidatamab-hrii) as a first-line treatment for HER2-positive gastroesophageal adenocarcinoma.
The trial demonstrated that Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in progression-free survival compared to trastuzumab and chemotherapy. It also showed a clinically meaningful effect with a strong trend toward statistical significance for overall survival at the first interim analysis.
Additionally, Ziihera combined with Tevimbra (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in both overall survival and progression-free survival versus the control arm.
Based on these results, Zymeworks’ partner Jazz Pharmaceuticals intends to submit a supplemental Biologics License Application in the first half of 2026 to support Ziihera as a first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.
The safety profile of Ziihera in combination with chemotherapy, with or without Tevimbra, was generally consistent with the known safety profile of each agent with no new safety signals observed.
Ziihera is currently approved in the U.S., Europe, and China for use in second-line biliary tract cancer and is marketed by Jazz and BeOne Medicines. Jazz plans to submit the data for presentation at a major medical meeting in the first quarter of 2026.
Zymeworks is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales of Ziihera from its partners.
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