The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) today recommended the approval of the combination of pembrolizumab plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first combination of immunotherapy (pembrolizumab) with a tyrosine kinase inhibitor (axitinib) to receive a recommendation for approval for advanced RCC, and is applicable to all patient risk groups (poor, intermediate and good).
This recommendation is based on findings from the open-label KEYNOTE-426 study involving 861 patients, which demonstrated significant improvements in overall survival, progression-free survival and objective response rate for the combination compared to sunitinib. In this study, median progression-free survival was 15.1 months for pembrolizumab/axitinib and 11.1 months with sunitinib. There was a 31% reduction in the risk of disease progression in patients taking the combination treatment.
Overall survival rates were higher at 12- and 18-months with pembrolizumab/axitinib than sunitinib, at 89.9% versus 78.3% and 82.3% versus 72.1%, respectively. Objective response rates were also higher in the combination group (59.3% versus 35.7% with sunitinib). Survival benefits were irrespective of PD-L1 status or risk group. Safety and tolerability were comparable between the two treatment groups.
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorisation in the European Union, and a final decision is expected in the third quarter of 2019.