Eisai has initiated a multicentre, global, randomised phase III study that will evaluate the efficacy and safety of lenvatinib in combination with anti-PD-1 immunotherapy pembrolizumab and lenvatinib in combination with everolimus versus sunitinib in patients with advanced renal cell carcinoma (RCC) in a first-line setting.
In the European Union, pembrolizumab is marketed by MSD under the brand name Keytruda®.
The study (Study 307) is designed to assess the progression-free survival (PFS) of patients treated with these combinations. Secondary endpoints include objective response rate, overall survival and safety. It is the first phase III trial to assess lenvatinib in combination with pembrolizumab, an anti-PD-1 (programmed death receptor-1) immunotherapy, in previously untreated patients with advanced RCC.
Around 270,000 cases of kidney cancer are diagnosed globally each year and 116,000 people die from the disease. Approximately 90% of all kidney cancers are renal cell carcinomas.
In August 2016, the European Commission issued a marketing authorisation for lenvatinib in combination with everolimus for the treatment of adult patients with advanced RCC following one prior vascular endothelial growth factor (VEGF)-targeted therapy.