Table 1 Front-line, phase 3 immune checkpoint inhibitor-based trials in advanced RCC

CheckMate 214

(NCT02231749)

[9, 10]

Nivolumab + Ipilimumab vs. Sunitinib

ITT Population

12-mo: 83% vs. 77%

30-mo: 64% vs. 56%

(HR 0.71; 0.59 to 0.86; P = 0.0003)

I/P Risk Patients

12-mo: 80% vs. 72%

30-mo: 60% vs. 47%

(HR 0.66; 0.54 to 0.80; P < 0.0001)

Favorable Risk

12-mo: 94% vs. 96%

30-mo: NR vs. NR;

(HR 1.22; 0.73 to 2.04)

ITT Population^a

mPFS: 9.7 vs. 9.7

(HR 0.85; 0.73 to 0.98; P = 0.027, NS)

I/P Risk Patients^a

mPFS: 8.2 vs. 8.3

(HR 0.77; 0.65 to 0.90; P = 0.001, NS)

Favorable Risk^a

mPFS: 13.9 vs. 19.9 (HR 1.23; 0.90 to 1.69; P = 0.189, NS)

ITT Population^a

41% vs. 34%; (P = 0.0154, NS)

CR: 11% vs. 2%

I/P Risk Patients^a

42% vs. 29%; (P < 0.001)

CR: 11% vs. 1%

Favorable Risk^a

ORR: 39% vs. 50%; (P = 0.1436)

CR: 8% vs. 4%

Keynote-426

(NCT02853331)

[11]

Pembrolizumab + Axitinib vs. Sunitinib

ITT Population

12-mo: 90% vs 78%

(HR 0.53; 0.38–0.74; P < 0.0001)

ITT Population

mPFS: 15.1 vs. 11.1 (HR 0.69; 0.57–0.84; P = 0.0001)

ITT Population

ORR: 59% vs 36%; P < 0.0001)

CR: 5.8% vs. 1.9%

Javelin RENAL 101

(NCT02684006)

[12, 13]

Avelumab + Axitinib vs. Sunitinib

ITT Population

12-mo: 86% vs. 83%

(HR 0.78; 0.55 to 1.08; p = 0.14)

ITT Population

mPFS: 13.8 vs. 8.4

(HR 0.69; 0.56 to 0.84; P < 0.0001)

ITT Population

ORR: 51% vs. 26%

CR: 3.4% vs. 1.8%

IMmotion151

(NCT02420821)

[14]

Atezolizumab + Bevacizumab vs. Sunitinib

ITT Population

24-mo: 63% vs. 60%

(HR 0.93; 0.76 to 1.14; p = 0.4751)

ITT Population^a

mPFS: 11.2 vs. 8.4 (HR 0.83; 0.70 to 0.97; p = 0.0219)

ITT Population

ORR: 37% vs. 33%