First-line ICIs in renal cell carcinoma

Figures & data

Table 1. Clinical trials for ICIs as first-line treatment of mRCC.

Trial (study name)	Targeting agents and comparison	ORR stratified according to IMDC risk groups	PFS stratified according to IMDC risk groups	OS stratified according to IMDC risk groups	G3–5 adverse events according to IMDC risk groups (RR compared to sunitinib)
CheckMate 214	Nivolumab + ipilimumab vs. sunitinib	Favourable: 29.6 vs. 51.6% (p = .0005) Intermediate-poor: 41.9 vs. 26.8% (p < .0001)	Favourable: 12.4 vs. 28.9 months; HR 1.84; 95% CI 1.29–2.62 Intermediate-poor: 11.2 vs. 8.3 months; HR 0.74; 95% CI 0.62–0.88	Favourable: HR 0.93; 95% CI: 0.62–1.4; OS not reached Intermediate-poor: 48.1 vs. 26.6 months; 50% vs. 35.8%; HR 0.65; 95% CI 0.54–0.78	Intermediate-poor risk group: RR 0.73; 95% CI: 0.65–0.81
KEYNOTE−426	Pembrolizumab + axitinib vs. sunitinib	All risk groups: 59.3% vs. 35.7%; p < .001	All risk groups: 15.4 vs. 11.1 months; p < .0001	All risk groups: HR 0.68; 95% CI 0.55–0.85; p = .0003; median OS not reached	All risk groups: RR 2.56; 95% CI: 1.85–3.54
CLEAR-KN581	Pembrolizumab + lenvatinib (1^st group) or everolimus + lenvatinib (2^nd group) vs. sunitinib (control)	All risk groups: 71% (1^st group) vs. 53.5% (2^nd group) vs. 36.1% (control); p value not available	All risk groups: 23.9 vs. 9.2 months, p < .001 (1^st group vs. control); 14.7 vs. 9.2 months, p  < .01 (2^nd group vs. control)	All risk groups: HR 0.66; 95% CI 0.49–0.88; p = .005; OS not reached (1^st group vs. control; exception observed in patients with favorable risk features) All risk groups: HR 1.15; 95% CI 0.88–1.5; p = .3; OS not reached (2^nd group vs. control)	All risk groups: RR 1.15; 95% CI: 1.06–2.05 (1^st group); incidence of G3–5 adverse events: 82.4% of lenvatinib + pembrolizumab patients vs. 83.1% of lenvatinib + everolimus patients vs. 71.8% of sunitinib patients
CheckMate−9ER	Nivolumab + cabozantinib vs. sunitinib	55.7% vs. 27.1%; p < .001	All risk groups: 16.6 vs. 8.3 months; HR 0.51; 95% CI 0.41–0.64; p < .0001	All risk groups: 85.7% vs. 75.6% at 12 months; HR 0.6; 98% CI 0.4–0.89; p = .001	All risk groups (incidence of G3–5 adverse events): 75.3% of nivolumab + cabozantinib patients vs. 70.6% of sunitinib patients