TABLE 2.
Trials of immunotherapy combination regimens in treatment-naive metastatic RCC.a
| Trial | CheckMate 214.Motzer et al14 | KEYNOTE-426.Rini et al15 | JAVELIN 101.Motzer et al63 | IMmotion151.Rini et al64 | ||||
|---|---|---|---|---|---|---|---|---|
| Treatment arm | Nivo + Ipi (n = 425)b | Sun (n = 422)b | Pembro + Axi (n = 432) | Sun (n = 429) | Avelu + Axi (n = 442) | Sun (n = 444) | Atezo + Beva (n = 454) | Sun (n = 461) |
| ORR (%) | 42 | 27 | 59.3 | 35.7 | 51.4 | 25.7 | 37 | 33 |
| CRR (%) | 9 | 1 | 5.8 | 1.9 | 3.4 | 1.8 | 5 | 2 |
| Median progression-free survival, mo | 11.6 | 8.4 | 15.1 | 11.1 | 13.8 | 8.4 | 11.2 | 8.4 |
| Hazard ratio for disease progression or death | 0.82 (P = 0.03, not significant per prespecified 0.009 threshold) | 0.69 (95% CI, 0.57-0.84; P < 0.001) | 0.69 (95% CI, 0.56-0.84; P < 0.001).PD-L1+: 0.61 (95% CI, 0.47-0.79; P < 0.001) | 0.83 (95% CI, 0.70-0.97).PD-L1+: 0.74 (95% CI, 0.57-0.96; P = 0.02) | ||||
| Median overall survival, mo | NR | 26.0 | NR | NR | NR | NR | 33.6 | 34.9 |
| Hazard ratio for death | 0.63 (99.8% CI, 0.44-0.89; P < 0.001) | 0.53 (95% CI, 0.38-0.74; P < 0.0001) | 0.78 (95% CI, 0.55-1.08; P = 0.14) | 0.93 (95% CI, 0.76-1.14) | ||||
Atezo, atezolizumab; Avelu, avelumab; Axi, axitinib; Beva, bevacizumab; CI, confidence interval; CRR, complete response rate; Ipi, ipilimumab; Nivo, nivolumab; NR, not reached; ORR, objective response rate; PD-L1+, programmed cell death 1 ligand 1 positive; Pembro, pembrolizumab; RCC, renal cell carcinoma; Sun, sunitinib.
aTransplant recipients excluded.
bIntermediate or poor prognostic risk groups.