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.
23 Articles
23 Articles
Why Is Jazz Pharmaceuticals Stock Trading Higher Today? - Jazz Pharmaceuticals (NASDAQ:JAZZ)
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) on Tuesday shared efficacy and safety results from the Phase 3 HERIZON-GEA-01 trial of Ziihera (zanidatamab-hrii) for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). GEA includes cancers of the stomach, gastroesophageal junction, and esophagus. In November 2025, Jazz Pharmaceuticals and its partners Zymeworks Inc. (NASDAQ:ZYME) and BeOne Medicines Inc. (NASDAQ:ONC…
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...
ZIIHERA Plus TEVIMBRA and Chemotherapy: A Potential New Standard for First-Line HER2+ Advanced GEA
SAN CARLOS, Calif.--(BUSINESS WIRE)--Jan 6, 2026-
Jazz and Zymeworks spell out HER2 bispecific win in form of advanced stomach cancer
Jazz Pharmaceuticals and Zymeworks detailed successful results from a late-stage trial of Ziihera that they say support the potential of replacing Herceptin in a form of advanced stomach and esophagus cancer. The drugmakers
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