Table 2.
Main efficacy endpoints and summary of safety, study KEYNOTE-426
| Efficacy endpoint | Pembrolizumab axitinib (n=432) |
Sunitinib (n=429) |
| Overall survival | ||
| Number of death events, n (%) | 59 (14) | 97 (23) |
| Median overall survival (months) (95% CI) | NR | NR |
| Stratified HR (95% CI) | 0.59 (0.38 to 0.74) | |
| Stratified log-rank test, p value | 0.00005 | |
| PFS* | ||
| Number of events, n (%) | 183 (42) | 213 (50) |
| Median PFS (months) (95% CI) | 15.1 (12.6 to 17.7) | 11.0 (8.7 to 12.5) |
| Stratified HR (95% CI) | 0.69 (0.56 to 0.84) | |
| Stratified log-rank test, p value | 0.00012 | |
| ORR (CR+PR) (%) (95% CI) | 59 (54 to 64) | 36 (31 to 40) |
| Stratified method of Miettinen and Nurminen test p value¶2 |
<0.0001 | |
| Safety (%) | ||
| Grade 3–5 AEs | 75.8 | 70.6 |
| SAEs | 40.3 | 31.3 |
| Drug-related hepatic AEs | 34.3 | 20.7 |
| Drug discontinuation due to hepatic AEs | 13.3 | 0.5 |
| Drug discontinuation to drug-related SAEs | 17 | 9.9 |
| IRRs | 1.7 | 0.5 |
| Proportion of subjects with exposures to drugs (%) | ||
| >6/>12 months | 77.9 /40.3 | 63.5/25.4 |
Stratification factors, International Metastatic RCC Database Consortium risk group: favourable versus intermediate versus poor risk groups and geographical region: North America versus Western Europe versus ’rest of the world’.
*Assessed by Blinded Independent Central Review using RECIST V.1.1.
AE, adverse event; CR, complete response; IRR, infusion-related reaction; ORR, overall response rate; PFS, progression-free survival; PR, partial response; SAE, serious adverse event.