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Lenvatinib plus pembrolizumab in patients with either treatment-naive or previously treated metastatic renal cell carcinoma (Study 111/KEYNOTE-146): A phase 1b/2 study

The Lancet Oncology Jun 19, 2021

Lee CH, Shah AY, Rasco D, et al. - In an open-label phase 1b/2 study, the combination of lenvatinib plus pembrolizumab was tested in patients with metastatic renal cell carcinoma (RCC). Patients aged at least 18 years with selected solid tumours and an Eastern Cooperative Oncology Group performance status of 0–1. Patients were administered oral lenvatinib at 20 mg once daily along with intravenous pembrolizumab at 200 mg once every 3 weeks. At week 24, an objective response by irRECIST (immune-related Response Evaluation Criteria In Solid Tumors) was achieved in 16 of 22 treatment-naive patients, seven of 17 previously treated immune checkpoint inhibitor (ICI)-naive patients, and 58 of 104 ICI-pretreated patients. Findings demonstrated not only encouraging antitumour activity of lenvatinib plus pembrolizumab but also a manageable safety profile of this combination, and thus, lenvatinib plus pembrolizumab might represent a choice for post-ICI treatment of metastatic RCC.

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