Gastric cancer refers to a type of cancer that occurs in the stomach. Pembrolizumab is an anti-PD-1 antibody that initiates tumor response in around 15% of advanced gastric cancer patients with PD-L1 combined positive score of 1 or more. Lenvatinib is a multikinase inhibitor that decreases tumor-associated macrophages. This study aims to investigate the effect of lenvatinib-pembrolizumab combination therapy in patients with advanced gastric cancer.
This single-arm, open-label, phase-2 trial included a total of 29 patients aged 20 years or older with metastatic or recurrent adenocarcinoma of the stomach. The patients were assigned to receive 20 mg oral lenvatinib daily with 200 mg intravenous pembrolizumab every 3 weeks until disease progression, withdrawal of consent, or intolerable toxicity. The primary outcome of the study was the objective response rate, according to the Response Evaluation Criteria in Solid Tumors (RECIST).
During a median follow-up of 12.6 months, an objective response occurred in 20 patients (60%). Common grade 3 treatment-related adverse events were hypertension (38%), proteinuria (17%), and platelet count decreased (7%). No treatment-related deaths were reported.
The findings concluded that lenvatinib-pembrolizumab combination therapy showed a positive response rate, along with good tolerability and safety profile in patients with advanced gastric cancer.