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This multi-agent regimen is a combination therapy used as a standard-of-care control in clinical trials for patients with previously untreated, HER2-positive, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. It integrates the HER2-targeted monoclonal antibody trastuzumab and the PD-1 checkpoint inhibitor pembrolizumab with a chemotherapy backbone consisting of either CAPOX (capecitabine and oxaliplatin) or FP (fluorouracil and cisplatin). The regimen leverages synergistic effects by simultaneously inhibiting the HER2 signaling pathway, restoring anti-tumor immune responses through PD-1 blockade, and inducing direct cytotoxic DNA damage. It is currently being evaluated as the active comparator against novel therapies like SHR-A1811 in Phase 3 studies sponsored by Suzhou Suncadia Biopharmaceuticals.
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