{"entity":{"id":"herizon-gea-01","kind":"trial","name":"HERIZON-GEA-01","aka":[],"tldr":"A two-armed HER2 antibody beat Herceptin head-to-head as first-line treatment for HER2-positive stomach cancer, the first such win since 2010.","summary":"HERIZON-GEA-01, trial NCT05152147 sponsored by Jazz and BeOne and reported in 2026, showed that the two-armed HER2 antibody zanidatamab beats trastuzumab head to head as first-line treatment for HER2-positive advanced gastro-oesophageal adenocarcinoma, the first such win since ToGA in 2010. It randomised 914 patients to zanidatamab plus chemotherapy, with or without tislelizumab, or trastuzumab plus chemotherapy, met its primary progression-free survival endpoint in both zanidatamab arms and significantly improved overall survival, as published in the New England Journal of Medicine in 2026, with a supplemental licence application planned for the first half of 2026. It sets up zanidatamab as the HER2 agent of choice, and how trastuzumab deruxtecan fits after it is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05152147","url":"https://clinicaltrials.gov/study/NCT05152147"},{"label":"ASCO GI 2026 LBA285","url":"https://ascopubs.org/doi/10.1200/JCO.2026.44.2_suppl.LBA285"}],"tags":[],"related":[],"cancers":["gastric","esophageal"],"sections":[],"technologies":["bispecific-antibody"],"targets":["her2","pd1"],"drugs":["zanidatamab","trastuzumab","tislelizumab"],"companies":["jazz","beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05152147","phase":"3","setting":"First-line HER2-positive advanced gastro-oesophageal adenocarcinoma: zanidatamab + chemotherapy ± tislelizumab vs trastuzumab + chemotherapy","sponsor":"Jazz / BeOne","result":"PFS 12.4 vs 8.1 months (HR 0.63-0.65); OS significantly improved.","started":"2021-12-02","startedType":"actual","yearReported":2026,"enrolled":920,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Zanidatamab + chemotherapy + tislelizumab","value":12.4},{"name":"Zanidatamab + chemotherapy","value":12.4},{"name":"Trastuzumab + chemotherapy","value":8.1}],"source":"https://ascopubs.org/doi/10.1200/JCO.2026.44.2_suppl.LBA285"}],"replication":"First phase 3; consistent with phase 2 (ORR 76% first line)."},"route":"/trials/herizon-gea-01/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"gastric-her2-positive","kind":"cancer","name":"HER2-positive gastric cancer","route":"/cancers/gastric-her2-positive/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"tislelizumab","kind":"drug","name":"Tislelizumab","route":"/drugs/tislelizumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"},{"id":"zanidatamab","kind":"drug","name":"Zanidatamab","route":"/drugs/zanidatamab/"}],"company":[{"id":"beone","kind":"company","name":"BeOne Medicines (formerly BeiGene)","route":"/companies/beone/"},{"id":"jazz","kind":"company","name":"Jazz Pharmaceuticals","route":"/companies/jazz/"}],"pairing":[{"id":"her2-gastric-sequence","kind":"pairing","name":"HER2 sequence in gastric cancer: zanidatamab/trastuzumab + chemo ± PD-1 → T-DXd","route":"/pairings/her2-gastric-sequence/"}],"idea":[{"id":"idea-biomarker-quadruplet-gastric","kind":"idea","name":"Biomarker-directed first-line quadruplets in gastric cancer","route":"/ideas/idea-biomarker-quadruplet-gastric/"}]}}