Jazz的Ziihera一线HER2阳性胃食管腺癌方案获FDA批准

Jazz Pharmaceuticals (JAZZ), a global biopharmaceutical company, announced that the U.S. FDA approved two Ziihera (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA).
Ziihera plus tislelizumab-jsgr and fluoropyrimidine- and platinum-containing chemotherapy was approved for HER2+ GEA patients with IHC 3+ or IHC 2+/ISH+ status, regardless of PD-L1 status.
Ziihera plus chemotherapy was approved for patients with HER2 IHC 3+ disease.
Gastroesophageal adenocarcinoma includes cancers of the stomach, gastroesophageal junction and esophagus and remains associated with poor outcomes, with approximately 20% of patients having HER2-positive disease.
The approvals were supported by results from the Phase 3 HERIZON-GEA-01 trial, in which both Ziihera-containing regimens significantly improved progression-free survival compared with trastuzumab plus chemotherapy.
The Ziihera plus tislelizumab-jsgr and chemotherapy regimen reduced the risk of death by 28%, achieving median overall survival of 26.4 months versus 19.2 months with trastuzumab plus chemotherapy.
The regimen also reduced the risk of disease progression or death by 35%, with median progression-free survival of 12.4 months versus 8.1 months for the control arm.
Ziihera is a bispecific HER2-directed antibody designed to bind two extracellular sites on HER2, promoting receptor internalization and immune-mediated mechanisms that inhibit tumor growth and induce cancer-cell death.
The FDA approval establishes Ziihera plus tislelizumab-jsgr and chemotherapy as a first-line treatment option for a broad population of HER2-positive advanced GEA patients, including those regardless of PD-L1 status.
The most common adverse reactions associated with the Ziihera-containing regimens included diarrhea, nausea, decreased appetite, vomiting, hypokalemia, fatigue, rash, peripheral neuropathy and infusion-related reactions.
JAZZ has traded between $122.50 and $266.16 over the past 52 weeks year.
JAZZ is currently at $263.48, up 3.50%.
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