The Food and Drug Administration (FDA) in the United States has approved the pembrolizumab (Keytruda) plus axitinib (Inlyta) combination for first-line treatment of advanced renal cell carcinoma (RCC).

The approval comes two months earlier than expected and is based on the results from the open-label KEYNOTE-426 study involving 861 patients. 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. Survival benefits were irrespective of PD-L1 status or risk group. Objective response rates were also higher in the combination group (59.3% versus 35.7% with sunitinib). Safety and tolerability were comparable between the two treatment groups.

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