Agent

Patients

Number

Control

PFS (months)

probability

OS (months)

probability

US-FDA approval

References

 

sorafenib

cytokine refractory

903

placebo

5.5 vs 2.8

<0.01

17.8 vs 15.2

0.146

approved

6, 15

sunitinib

treatment naïve

750

interferon

11 vs 5

<0.001

26.4 vs 21.8

0.051

approved

7, 17

bevacizumab

treatment naïve  treatment naïve or cytokine

649

interferon

10.2 vs 5.4

0.0001

23.3 vs 21.3

0.336

approved

8, 18

pazopanib

refractory

435

placebo

9.2 vs 4.2

<0.001

ND

 

approved

9

temsirolimus

treatment naïve

625

interferon

3.8 vs 1.9

<0.001

10.9 vs 7.3

0.008

approved

10

everolimus

TKI refractory

410

placebo

4.0 vs 1.9

<0.0001

14.8 vs 14.4

0.162

approved

11,19

axitinib

cytokine or TKI refractory  treatment naïve or cytokine

723

sorafenib

6.7 vs 4.7

<0.0001

ND

 

approved

22

tivozanib

refractory

 

sorafenib

ND

 

ND

 

not yet

24

dovitinib

TKI and mTOR refractory

 

sorafenib

ND

 

ND

 

not yet

 

PFS: median progression free survival (agents versus control), OS: median overall survival (agents versus control), US-FDA: the United States Food and Drug Administration, TKI: tyrosine kinase inhibitor, mTOR: mammalian target of rapamycin
Table 1: Summary of the results of phase III clinical trials of molecular targeted agents for patients with metastatic renal cell cancer.