Table 1.
Main efficacy endpoints and summary of safety, study CA209214 for the intermediate/poor risk population
| Efficacy endpoint | Nivolumab ipilimumab (n=423) |
Sunitinib (n=416) |
| OS | ||
| Number of death events, n (%) | 166 (39) | 209 (49) |
| Median OS (months) (95% CI) | NE (28.2, NE) | 25.9 (22.1, NE) |
| Stratified HR (99.8% CI) | HR 0.63 (0.44 to 0.89) | |
| Stratified log-rank test, two-sided p value | <0.0001 | |
| PFS* | ||
| Number of death events, n (%) | 228 (53.6%) | 228 (54.0%) |
| Median PFS (months) (95% CI) | 11.6 (8.71 to 15.51) | 8.4 (7.03 to 10.81) |
| Stratified HR (99.1% CI) | HR 0.82 (0.64,1.05) | |
| Stratified log-rank test, two-sided p value | 0.0331 | |
| ORR* (CR+PR) (%) (95% CI) | 41.6 (36.9 to 46.5) | 26.5 (22.4,31.0) |
| Stratified DerSimonian-Laird test p value | <0.0001 | |
| Safety (%) | ||
| Drug-related AEs, grades 3–4 | 45.7 | 62.6 |
| SAEs | 55.8 | 39.8 |
| Drug discontinuation to drug-related SAEs | 21.6 | 11.8 |
| IRRs | 5.8 | 2.2 |
| Relative dose intensity (%) | ||
| 90% to ≥110% of the planned dose intensity | 87.5 (nivolumab) 80.3 (ipilimumab) |
58.5 |
Stratification factors International Metastatic RCC Database Consortium risk group: favourable versus intermediate versus poor risk groups and geographical region: USA versus Canada/Western Europe/Northern Europe versus ‘rest of the world’.
*Assessed by IRRC using RECIST V.1.1.
AE, adverse event; CI, Confidence Interval; CR, complete response; HR, hazard ratio; IRR, infusion-related reaction; IRRC, independent radiological review committee; NE, not evaluable; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; SAE, serious adverse event.