TABLE II.
Phase III trials in the first-line treatment of metastatic renal cell carcinoma with immune checkpoint inhibitors
| Variable | Motzer et al., 20186 (CheckMate 214) | Motzer et al., 20187 (IMmotion 151) | Motzer et al., 20198 (JAVELIN Renal 101) | Rini et al., 20199 (KEYNOTE-426) |
|---|---|---|---|---|
| Treatment arms | ||||
| Investigational | Ipilimumab–nivolumab | Atezolizumab–bevacizumab | Avelumab–axitinib | Pembrolizumab–axitinib |
| Comparator | Sunitinib | Sunitinib | Sunitinib | Sunitinib |
|
| ||||
| Included in primary analysis | ||||
| PD-L1 groups | Any | Any | ≥ 1% | Any |
| IMDC risk groups | Intermediate and poor risk | Any | Any | Any |
|
| ||||
| Primary outcome | OS, PFS, ORR | OS in ITT, PFS in PD-L1–positive | OS, PFS both in PD-L1–positive | OS, PFS |
|
| ||||
| Median OS (months) | ||||
| Investigational | Not estimable | Not estimable | Not estimable | Not estimable |
| Comparator | 26.0 | Not estimable | Not estimable | Not estimable |
| Hazard ratio | 0.63 | 0.81 | Not reached | 0.53 |
| p Value | <0.001 | 0.09 | <0.0001 | |
|
| ||||
| Median PFS (months) | ||||
| Investigational | 11.6 | 11.2 | 13.8 | 15.1 |
| Comparator | 8.4 | 7.7 | 7.2 | 11.1 |
| Hazard ratio | 0.82 | 0.74 | 0.61 | 0.69 |
| p Value | 0.03 | 0.02 | <0.001 | <0.001 |
|
| ||||
| Objective response rate (%) | ||||
| Investigational | 42 | 37 | 55 | 59 |
| Comparator | 27 | 33 | 26 | 36 |
|
| ||||
| Complete responses (%) | ||||
| Investigational | 9 | 5 | 3.4 | 5.8 |
| Comparator | 1 | 2 | 1.8 | 1.9 |
IMDC = International Metastatic Renal Cell Carcinoma Database Consortium; OS = overall survival; PFS = progression-free survival; ITT = intention-to-treat.