Pembrolizumab plus axitinib granted FDA approval for advanced kidney cancer

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.

Read more in Targeted Oncology here

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