Jazz Pharmaceuticals to Present Pivotal Phase 3 Results of Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma at the 2026 ASCO Gastrointestinal Cancers Symposium

Core Insights - Jazz Pharmaceuticals announced the acceptance of two abstracts featuring key data for Ziihera at the ASCO GI Symposium, highlighting its expanding clinical profile in HER2-driven gastrointestinal cancers [1][2] Group 1: HERIZON-GEA-01 Trial Results - The Phase 3 HERIZON-GEA-01 trial results for Ziihera in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) were accepted as a late-breaking presentation [1] - Ziihera plus chemotherapy and Ziihera plus tislelizumab demonstrated statistically significant improvements in progression-free survival (PFS) compared to the control arm [2] - Ziihera plus tislelizumab also showed significant improvements in overall survival (OS), while Ziihera plus chemotherapy indicated a strong trend toward statistical significance for OS [2] Group 2: Upcoming Webcast and Presentations - Jazz Pharmaceuticals will host an investor webcast on January 9, 2026, to review the Ziihera data presented at ASCO GI [3] - The webcast will feature commentary from senior management and a physician from Memorial Sloan Kettering Cancer Center [3] Group 3: Background on GEA and BTC - Gastroesophageal adenocarcinoma (GEA) is the fifth most common cancer globally, with a poor prognosis and a five-year survival rate of less than 30% for gastric cancer [8] - Biliary tract cancer (BTC) is rare but aggressive, with HER2 overexpression observed in approximately 26% of patients, leading to worse prognosis [11][9] Group 4: Ziihera Overview - Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that reduces HER2 expression on tumor cells, inducing tumor growth inhibition [12] - The FDA granted accelerated approval for Ziihera for previously treated HER2-positive BTC based on overall response rate and duration of response [14]