Table 1

Clinical trials leading to newly approved drugs for advanced renal cell carcinoma

Name of the studyType of studySettingnPrimary endpointTreatment armsMedian OSMedian PFSORRMost common grade 3–4 AEs
METEOR trialPhase III randomised open-labelSecond-line or later-line after ≥1 VEGFR inhibitor658PFSCabozantinib
(n=330)
21.4 months7.4 months21%Hypertension (15%), diarrhoea (13%), fatigue (11%), PPES (8%)
Everolimus
(n=328)
16.5 months
(HR 0.66, p=0.00026)
3.8 months (HR 0.58, p <0.001)5%
(p<0.001)
Anaemia (16%), fatigue (7%), hyperglycaemia (5%)
Phase II randomised open-labelSecond-line or later-line after ≥1 VEGFR inhibitor153PFSLenvatinib plus everolimus
(n=51)
25.5 months14.6 months43%Diarrhoea (20%), fatigue (14%), hypertension (14%), vomiting (8%), anaemia (8%)
Lenvatinib
(n=52)
19.1 months
(HR 0.75, p=0.32)*
7.4 months
(HR 0.66, p=0.12)*
27%
(p=0.10)*
Proteinuria (19%), hypertension (17%), diarrhoea (12%), fatigue (8%)
Everolimus
(n=50)
15.4 months
(HR 0.51, p=0.024)*
5.5 months
(HR 0.40, p=0.0005)*
6%
(p<0.0001)*
Anaemia (12%), dyspnoea (8%), hyperglycaemia (8%), hypertriglyceridaemia (8%)
CheckMate 025 trialPhase III randomised open-labelSecond-line or third-line after ≥1 VEGFR inhibitor821OSNivolumab
(n=406)
25.0 months4.6 months25%Fatigue (2%), anaemia (2%), diarrhoea (1%)
Everolimus
(n=397)
19.6 months
(HR 0.73, p=0.002)
4.4 months
(HR 0.88, p=0.11)
5%
(p<0.001)
Anaemia (8%), hypertriglyceridaemia (5%), hyperglycaemia (4%)
  • *As compared with combination arm (lenvatinib plus everolimus).

  • AE, adverse events; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PPES, palmar-plantar erythrodysesthesia syndrome; VEGFR, vascular endothelial growth factor receptor.