Jazz Pharmaceuticals(US:JAZZ) Prnewswire·2025-11-17 11:00Core Insights - Jazz Pharmaceuticals announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial, showing that Ziihera (zanidatamab-hrii) in combination with chemotherapy significantly improves progression-free survival (PFS) compared to trastuzumab and chemotherapy [1][4] - The trial also indicated a strong trend toward statistical significance for overall survival (OS) at the first interim analysis, with plans to submit a supplemental Biologics License Application (sBLA) in the first half of 2026 [1][2] Trial Results - Ziihera plus chemotherapy and Ziihera plus tislelizumab (PD-1 inhibitor) demonstrated statistically significant improvements in both OS and PFS compared to the control arm [1][4] - The trial involved 914 patients across over 300 sites in more than 30 countries, focusing on HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) [6][7] Future Plans - The company plans to present these findings at a major medical meeting in Q1 2026 and submit for publication in a peer-reviewed journal [3] - Jazz Pharmaceuticals aims to engage with the FDA quickly to support Ziihera as a first-line treatment for HER2+ locally advanced or metastatic GEA [2][3] Safety Profile - The safety profile of Ziihera in combination with chemotherapy was consistent with known safety profiles, with no new safety signals observed [2][4] - The trial's ongoing nature includes additional planned OS interim analyses expected in mid-2026 [4] Broader Research Context - HERIZON-GEA-01 is the first Phase 3 trial for Ziihera, with ongoing research including trials for biliary tract cancer and metastatic breast cancer [5][9] - Ziihera is a bispecific HER2-directed antibody that has shown potential in treating various solid tumors expressing HER2 [8][9]