Multicenter phase 2 trial of sintilimab plus axitinib for treatment-naïve, advanced fumarate hydratase-deficient renal cell carcinoma

Fumarate hydratase-deficient advanced renal cell carcinoma (FH-deficient aRCC) is a lethal kidney cancer with limited therapeutic options. A phase 2 nonrandomized trial at 8 centers in China evaluated the combination of sintilimab and axitinib among patients with previously untreated FH-deficient aRCC. Among 41 included patients, the objective response rate was 56%, with a median progression-free survival of 19.8 months and a manageable safety profile. The authors conclude that the combination of sintilimab an axitinib warrants further investigation in patients with FH-deficient aRCC.