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Phase 3 HERIZON-GEA-01 Results Published in The New England Journal of Medicine Show Durable and Consistent Survival Benefit with Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2+ Locally Advanced or Metastatic GEA
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the New England Journal of Medicine has published the Phase 3 HERIZON-GEA-01 trial results, further characterizing the efficacy and safety profile of Ziihera® (zanidatamab-hrii) in combination with chemotherapy, with and without the PD-1 inhibitor Tevimbra® (tislelizumab), as first-line treatment for adults with HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach,
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"Expanded safety, subgroup, progression-free survival sensitivity and subsequent therapy analyses further characterize the consistency and durability of outcomes observed with zanidatamab-containing combinations in the first-line setting","length":236,"tagName":"p","attribs":{}},{"type":"text","content":"Additional subgroup analyses to be presented at the 2026 ASCO Annual Meeting show improved clinical outcomes with zanidatamab-containing combinations regardless of PD-L1 expression, including in PD-L1-negative patients","length":218,"tagName":"p","attribs":{}},{"type":"text","content":"For U.S. media and investors only","length":43,"tagName":"p"},{"type":"text","content":"DUBLIN, May 27, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the New England Journal of Medicine has published the Phase 3 HERIZON-GEA-01 trial results, further characterizing the efficacy and safety profile of Ziihera® (zanidatamab-hrii) in combination with chemotherapy, with and without the PD-1 inhibitor Tevimbra® (tislelizumab), as first-line treatment for adults with HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction, and esophagus.","length":584,"tagName":"p"},{"type":"text","content":"The manuscript builds on the late-breaking oral presentation of the HERIZON-GEA-01 trial results at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO GI), where zanidatamab-containing combinations demonstrated unprecedented progression-free survival (PFS) and overall survival (OS) outcomes in a global Phase 3 trial.","length":322,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"As previously reported, both zanidatamab-containing combinations significantly improved PFS compared with trastuzumab plus chemotherapy (median PFS 12.4 months versus 8.1 months; Hazard Ratio (HR) 0.63-0.65), and zanidatamab plus tislelizumab and chemotherapy demonstrated a statistically significant OS benefit (median OS 26.4 versus 19.2 months; HR 0.72).","length":357,"tagName":"p"}]},{"val":[{"type":"text","content":"At the first interim analysis, zanidatamab plus chemotherapy also demonstrated a median OS of more than two years. The OS for zanidatamab plus chemotherapy will be assessed at a second interim analysis expec...