Zymeworks Inc. (NASDAQ:ZYME) stock is surging on Monday, with a session volume of 2.17 million, compared to an average volume of 728.75K, according to Benzinga Pro.
Zymework, along with its partners, Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ) and BeOne Medicines Inc. (NASDAQ:ONC), announced topline results from the Phase 3 HERIZON-GEA-01 trial.
The study evaluated Ziihera (zanidatamab-hrii) in combination with chemotherapy, with or without BeOne’s Tevimbra (tislelizumab), as a first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma.
Both Ziihera plus chemotherapy and Ziihera plus Tevimbra and chemotherapy demonstrated highly statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to the control arm, trastuzumab plus chemotherapy.
Ziihera plus Tevimbra and chemotherapy also demonstrated clinically meaningful and statistically significant improvements in overall survival (OS).
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Ziihera plus chemotherapy demonstrated a clinically meaningful effect, with a strong trend toward statistical significance in OS compared with the control arm at the time of this first analysis.
The trial is ongoing with an additional planned OS interim analysis for Ziihera plus chemotherapy currently expected in mid-2026.
A PFS and OS benefit was observed in the Ziihera plus Tevimbra and chemotherapy arm versus the control arm in both PD-L1-positive and PD-L1-negative subgroups.
Both Ziihera plus Tevimbra and chemotherapy, and Ziihera plus chemotherapy demonstrated improvements in the key secondary endpoints of objective response rate (ORR) and duration of response (DoR) versus the control arm, and these endpoints were supportive of the primary efficacy endpoints.
Jazz plans to submit these data for presentation at a major medical meeting in the first quarter of 2026 for publication in a peer-reviewed journal, and for rapid adoption in the National Comprehensive Cancer Network Guidelines.
Jazz expects 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+ locally advanced or metastatic GEA for use as part of a standard chemotherapy regimen with or without Tevimbra.
Zanidatamab is currently approved in the U.S., Europe, and China for the treatment of second-line biliary tract cancer and is marketed under the trade names Ziihera by Jazz and BeOne.
Zymeworks is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales of Ziihera from Jazz and BeOne.
Price Action: ZYME stock is up 36.20% at $25.23, JAZZ stock is up 20.45% at $169.92, and ONC stock is up 3.37% at $378.14 at the last check on Monday.
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