HERIZON-GEA-01: Zanidatamab + chemo ± tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma
Josep Tabernero, Lin Shen, Elena Elimova, Geoffrey Ku, Tianshu Liu, Kohei Shitara, Xiao Lin, Lisa Boyken, Huiyan Li, Jonathan Grim, Jaffer Ajani, Josep Tabernero, Lin Shen, Elena Elimova, Geoffrey Ku, Tianshu Liu, Kohei Shitara, Xiao Lin, Lisa Boyken, Huiyan Li, Jonathan Grim, Jaffer Ajani
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.
Trial registration: ClinicalTrials.gov NCT05152147.
Keywords: GEA; HER2; PD-1/PD-L1 inhibitor; esophageal adenocarcinoma; gastric cancer; gastroesophageal adenocarcinoma; gastroesophageal junction cancer; human epidermal growth factor receptor 2; tislelizumab; zanidatamab.
Source: PubMed