Table 3.
Main efficacy endpoints and summary of safety, study JAVELIN Renal 101
| Efficacy endpoint | Avelumab axitinib (n=442) |
Sunitinib (n=444) |
| Overall survival* | ||
| Number of death events, n (%) | 109 (25.7) | 129 (29.1) |
| Median overall survival (months) (95% CI) | NR (30, NE) | NE (27.4, NE) |
| Stratified HR (95% CI) | 0.8 (0.616 to 1.027) | |
| Stratified log-rank test, one-sided p value | 0.0392 | |
| PFS* | ||
| Number of events, n (%) | 229 (52) | 258 (58) |
| Median PFS (months) (95% CI) | 13.3 (11.1 to 15.3) | 8.0 (6.7 to 9.8) |
| Stratified HR (95% CI) | 0.69 (0.57 to 0.83) | |
| Stratified log-rank test, one-sided p value | <0.0001 | |
| ORR* (CR+PR) (%) (95% CI) | 232 (52.5) (47.7 to 57.2) | 121 (27.3) (23.2 to 31.6) |
| Stratified method, Clopper–Pearson OR | OR 2.996 (2.230 to 3.998) | |
| Safety (%) | ||
| irAEs | 38.9 | 5.0 |
| TEAEs | 99.6 | 99.3 |
| Grade>3 TEAEs | 71.6 | 71.5 |
| STEAEs | 35.4 | 28.7 |
| Drug discontinuation to drug-related TEAEs | 14.9 | 3.3 |
| IRRs | 28.4 | 0 |
| Dose intensity (%) | ||
| Relative dose intensity | 92.3 | 88.4 |
Stratification factors ECOG PS 0 vs 1 and region (USA vs Canada/Western Europe vs the rest of the world).
*Assessed by Blinded Independent Central Review using RECIST V.1.1, irrespective of programmed death ligand 1 expression.
AE, adverse event; CR, complete response; ECOG, Eastern Cooperative Oncology Group; irAE, immune-related adverse event; IRR, infusion-related reaction; NE, non evaluable; ORR, overall response rate; PFS, progression-free survival; PR, partial response; STEAE, serious treatment emergent adverse event; TEAE, treatment emergent adverse event.