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ZIIHERA Plus TEVIMBRA and Chemotherapy: A Potential New Standard for First-Line HER2+ Advanced GEA

Ziihera plus chemotherapy demonstrated a median overall survival of 26.4 months, a 28% reduction in death risk, supporting a new first-line standard for HER2+ gastroesophageal cancer.

  • Zymeworks announced positive Phase 3 HERIZON-GEA-01 results for Ziihera on January 8, 2026, with late-breaking data to be presented at ASCO-GI.
  • The Phase 3 HERIZON-GEA-01 trial randomized 914 patients across approximately 300 trial sites in more than 30 countries, addressing the urgent need for new first-line options in HER2-positive gastroesophageal adenocarcinoma .
  • Trial data showed higher Grade ≥3 treatment-related adverse events with investigational arms, with both Ziihera plus chemotherapy regimens reducing progression or death risk by about 35%; diarrhea generally resolved within three weeks.
  • Zymeworks plans regulatory submissions for Ziihera, with potential milestone payments up to $440.0 million, supported by positive HERIZON-GEA-01 results and planned OS analysis in mid-2026.
  • With a median OS of 26.4 months, the regimen showed a 28% reduction in risk of death versus trastuzumab, with benefits consistent across PD-L1 status and geographic region.
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23 Articles

PR NewswirePR Newswire
+14 Reposted by 14 other sources
Center

Ziihera® (zanidatamab-hrii) Combinations Achieve Unprecedented Results in First-Line HER2+ Locally Advanced or Metastatic GEA Including More Than Two Years Median Overall Survival Benefit

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive efficacy and safety results from the Phase 3 HERIZON-GEA-01 trial evaluating...

·United States
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The Bakersfield CalifornianThe Bakersfield Californian
+4 Reposted by 4 other sources
Center

ZIIHERA Plus TEVIMBRA and Chemotherapy: A Potential New Standard for First-Line HER2+ Advanced GEA

SAN CARLOS, Calif.--(BUSINESS WIRE)--Jan 6, 2026-

·Bakersfield, United States
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The Record broke the news in Waterloo, Canada on Tuesday, January 6, 2026.
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