Front-line, phase 3 immune checkpoint inhibitor-based trials in advanced RCC
| Trial | Description | Results (combination vs. SOC), 95% CI | ||
|---|---|---|---|---|
| OS | PFS (months) | Objective Response | ||
| CheckMate 214(NCT02231749)[9, 10] | Nivolumab + Ipilimumab vs. Sunitinib | ITT Population12-mo: 83% vs. 77%30-mo: 64% vs. 56%(HR 0.71; 0.59 to 0.86; P = 0.0003)I/P Risk Patients12-mo: 80% vs. 72%30-mo: 60% vs. 47%(HR 0.66; 0.54 to 0.80; P < 0.0001)Favorable Risk12-mo: 94% vs. 96%30-mo: NR vs. NR;(HR 1.22; 0.73 to 2.04) | ITT PopulationamPFS: 9.7 vs. 9.7(HR 0.85; 0.73 to 0.98; P = 0.027, NS)I/P Risk PatientsamPFS: 8.2 vs. 8.3(HR 0.77; 0.65 to 0.90; P = 0.001, NS)Favorable RiskamPFS: 13.9 vs. 19.9 (HR 1.23; 0.90 to 1.69; P = 0.189, NS) | ITT Populationa41% vs. 34%; (P = 0.0154, NS)CR: 11% vs. 2%I/P Risk Patientsa42% vs. 29%; (P < 0.001)CR: 11% vs. 1%Favorable RiskaORR: 39% vs. 50%; (P = 0.1436)CR: 8% vs. 4% |
| Keynote-426(NCT02853331)[11] | Pembrolizumab + Axitinib vs. Sunitinib | ITT Population12-mo: 90% vs 78%(HR 0.53; 0.38–0.74; P < 0.0001) | ITT PopulationmPFS: 15.1 vs. 11.1 (HR 0.69; 0.57–0.84; P = 0.0001) | ITT PopulationORR: 59% vs 36%; P < 0.0001)CR: 5.8% vs. 1.9% |
| Javelin RENAL 101(NCT02684006)[12, 13] | Avelumab + Axitinib vs. Sunitinib | ITT Population12-mo: 86% vs. 83%(HR 0.78; 0.55 to 1.08; p = 0.14) | ITT PopulationmPFS: 13.8 vs. 8.4(HR 0.69; 0.56 to 0.84; P < 0.0001) | ITT PopulationORR: 51% vs. 26%CR: 3.4% vs. 1.8% |
| IMmotion151(NCT02420821)[14] | Atezolizumab + Bevacizumab vs. Sunitinib | ITT Population24-mo: 63% vs. 60%(HR 0.93; 0.76 to 1.14; p = 0.4751) | ITT PopulationamPFS: 11.2 vs. 8.4 (HR 0.83; 0.70 to 0.97; p = 0.0219) | ITT PopulationORR: 37% vs. 33% |
a Investigator-assessed, data not assessed by Independent Review Committee (IRC)