Abstract
HER2-positive gastroesophageal adenocarcinomas (GEAs) are common cancers with high mortality and the treatment options for advanced/metastatic disease are limited. Zanidatamab and tislelizumab are novel monoclonal antibodies targeting HER2 and PD-1, respectively, and have shown encouraging antitumor activity in early phase studies in multiple cancers, including GEA. Preliminary data suggest that dual targeting of the HER2 and PD-1 pathways could further improve upon the results achieved with targeting either pathway alone. Here, we describe the design of HERIZON-GEA-01, a global, randomized, open-label, active-comparator, Phase III study to evaluate and compare the efficacy and safety of zanidatamab plus chemotherapy with or without tislelizumab to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for patients with advanced/metastatic HER2-positive GEAs. Tweetable abstract HERIZON-GEA-01: A phase III study of zanidatamab + chemotherapy ± tislelizumab for first-line treatment of advanced or metastatic #HER2-positive gastroesophageal adenocarcinoma (GEA). Clinicaltrials.gov: NCT05152147. #gastriccancer #stomachcancer @ZymeworksInc @BeiGeneGlobal Clinical Trial Registration: NCT05152147 (ClinicalTrials.gov.
Original language | English (US) |
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Pages (from-to) | 3255-3266 |
Number of pages | 12 |
Journal | Future Oncology |
Volume | 18 |
Issue number | 29 |
DOIs | |
State | Published - Sep 1 2022 |
Keywords
- esophageal adenocarcinoma
- gastric cancer
- gastroesophageal adenocarcinoma
- gastroesophageal junction cancer
- GEA
- HER2
- human epidermal growth factor receptor 2
- PD-1/PD-L1 inhibitor
- tislelizumab
- zanidatamab
ASJC Scopus subject areas
- Oncology
- Cancer Research