Table 2.
Main outcomes from second-line and later therapy studies in metastatic renal cell carcinoma approved by the FDA and EMA based on randomized clinical trials.
| Study drug | Control arm | Patients | Risk groups (%)* | Primary endpoint | Median PFS (months) | HR PFS (95% CI) | Median OS (months) | HR OS (95% CI) | ORR (%) |
|---|---|---|---|---|---|---|---|---|---|
|
Sorafenib28,29
TARGET study |
Placebo | 903 | F: 51 I: 49 P: 0 |
OS | 5.5 versus 2.8 | 0.44 (0.35–0.55) | 17.8 versus 15.2 | 0.88 (0.74–1.04) | 10 versus 2 |
|
Everolimus30,31
RECORD-1 study |
Placebo | 410 | F: 29 I: 56 P: 15 |
PFS | 4.9 versus 1.9 | 0.33 (0.25–0.43) | 14.8 versus 14.4 | 0.87 (0.65–1.17) | 1.8 versus 0 |
|
Axitinib32,33
AXIS study |
Sorafenib | 723 | F: 28 I: 37 P: 33 |
PFS | 6.7 versus 4.7 | 0.665 (0.544–0.812) | 20.1 versus 19.2 | 0.969 (0.800–1.174) | 19 versus 9 |
|
Nivolumab4
CHECKMATE025 Study |
Everolimus | 821 | F: 36 I: 49 P: 15 |
OS | 4.6 versus 4.4 | 0.88 (0.75–1.03) | 25.0 versus 19.6 | 0.73 (0.57–0.93) | 25 versus 5 |
|
Cabozantinib5,34
METEOR study |
Everolimus | 658 | F: 46 I: 42 P: 13 |
PFS | 7.4 versus 3.9 | 0.51 (0.41–0.62) | 21.4 versus 16.5 | 0.66 (0.53–0.83) | 17 versus 3 |
|
Lenvatinib + Everolimus6
phase II study |
Lenvatinib Everolimus |
153 | F: 16 I: 61 P: 22 |
PFS | 12.8 versus 9.0 (lenvatinib) versus 5.6 (everolimus) | 0.45 (0.27–0.79) for lenvatinib + everolimus compared with everolimus | 25.5 versus 19.1 versus 15.1 | 0.51 (0.30–0.88) for lenvatinib + everolimus compared with everolimus | 35 versus 39 versus 0 |
In case updated study outcomes were published these results are reported.
*
F, favourable; I, intermediate; P, poor according to the MSKCC criteria.27
CI, confidence interval; EMA, European Medicines Agency; FDA, US Food and Drug Administration; HR, hazard ratio; IL-2, interleukin-2; INF-α, interferon α; MSKCC, Memorial Sloan Kettering Cancer Center; ORR, objective response rate; OS, overall survival; PFS, progression free survival.