Skip to main content

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

From: The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of advanced renal cell carcinoma (RCC)

TrialDescriptionResults (combination vs. SOC), 95% CI
OSPFS (months)Objective Response
CheckMate 214
(NCT02231749)
[9, 10]
Nivolumab + Ipilimumab vs. SunitinibITT 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 Populationa
mPFS: 9.7 vs. 9.7
(HR 0.85; 0.73 to 0.98; P = 0.027, NS)
I/P Risk Patientsa
mPFS: 8.2 vs. 8.3
(HR 0.77; 0.65 to 0.90; P = 0.001, NS)
Favorable Riska
mPFS: 13.9 vs. 19.9 (HR 1.23; 0.90 to 1.69; P = 0.189, NS)
ITT Populationa
41% vs. 34%; (P = 0.0154, NS)
CR: 11% vs. 2%
I/P Risk Patientsa
42% vs. 29%; (P < 0.001)
CR: 11% vs. 1%
Favorable Riska
ORR: 39% vs. 50%; (P = 0.1436)
CR: 8% vs. 4%
Keynote-426
(NCT02853331)
[11]
Pembrolizumab + Axitinib vs. SunitinibITT 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. SunitinibITT 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. SunitinibITT Population
24-mo: 63% vs. 60%
(HR 0.93; 0.76 to 1.14; p = 0.4751)
ITT Populationa
mPFS: 11.2 vs. 8.4 (HR 0.83; 0.70 to 0.97; p = 0.0219)
ITT Population
ORR: 37% vs. 33%
  1. a Investigator-assessed, data not assessed by Independent Review Committee (IRC)