Lenvatinib plus pembrolizumab in patients with advanced gastric cancer in the first-line or second-line setting (EPOC1706): an open-label, single-arm, phase 2 trial
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View abstract on PubMed
Summary
This summary is machine-generated.The combination of lenvatinib and pembrolizumab demonstrated significant anti-tumour activity in advanced gastric cancer patients. This novel treatment approach showed a high objective response rate with manageable side effects, paving the way for future trials.
Area Of Science
- Oncology
- Immunotherapy
- Gastrointestinal Cancer Research
Background
- Pembrolizumab (anti-PD-1 antibody) shows limited response (15%) in advanced gastric cancer with PD-L1 expression.
- Lenvatinib, a multikinase inhibitor, enhances anti-tumour activity of PD-1 inhibitors by reducing tumour-associated macrophages and increasing CD8 T cell infiltration.
Purpose Of The Study
- To evaluate the efficacy and safety of combining lenvatinib with pembrolizumab in patients with advanced gastric cancer.
- To determine the objective response rate (ORR) as the primary endpoint in a phase 2 clinical trial.
Main Methods
- An open-label, single-arm, phase 2 study conducted in Japan.
- 29 patients with metastatic or recurrent gastric/gastro-oesophageal junction adenocarcinoma received daily oral lenvatinib (20 mg) plus intravenous pembrolizumab (200 mg) every 3 weeks.
- Objective response rate (ORR) assessed by RECIST v1.1; safety analysis included all treated patients.
Main Results
- An objective response rate of 69% (20 out of 29 patients) was observed.
- The most frequent grade 3 treatment-related adverse events included hypertension (38%), proteinuria (17%), and decreased platelet count (7%).
- No grade 4 adverse events, serious adverse events, or treatment-related deaths were reported.
Conclusions
- Lenvatinib plus pembrolizumab exhibits promising anti-tumour activity and an acceptable safety profile in advanced gastric cancer.
- These findings support further investigation in a confirmatory trial for this patient population.
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