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Study Design
• Phase III trial
• Multicenter
• Open-label.
• controlled.
• Randomized
• 2016.
• The Lancet Oncology

Methods
• 658 patients.
• 18 years and older
• advanced or metastatic clear-cell renal cell carcinoma(amRCC).
• measurable disease.
• previous treatment with one or more VEGFR tyrosine-kinase
inhibitors.

Methods
• 1:1 ratio
• 2 Groups :
• 1-60 mg Cabozantinib once a day.
• 2-10 mg Everolimus once a day.

Methods

End Points
• Primary endpoint:
• Progression-free survival (PFS).
• Secondary endpoints:
• Overall survival (OS).
• Objective Response Rate (ORR).
• Safety.

METEOR : Baseline Characteristics

Study Results

Primary End Point (PFS)
49
%

Secondary End Points

Secondary End Point (OS)
44
%
16.5
21.4

Secondary End Point (ORR)
17.0%
3.0%
0.0%
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
14.0%
16.0%
18.0%
ORR
Response Rate
Cabozantinib Everolimus

Secondary End Point (Safety)
21.0%
63.0%
8.0%
32.0%
52.0%
8.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Any AE (1-2) Any AE (Grade3) Any AE (Grade4)
Cabozantinib Everolimus

Study Overview
• Cabozantinib improved progression-free survival (PFS), overall survival
(OS) and objective response rate (ORR) compared with Everolimus in
patients with advanced renal cell carcinoma (RCC) after prior
antiangiogenic therapy in the phase III METEOR trial.
• Limited data are available on the use of targeted therapies in older
patients with advanced RCC.

End Points
• Primary endpoint:
• Progression-free survival (PFS).
• Secondary endpoints:
• Overall survival (OS).
• Objective Response Rate (ORR).
• Safety.

Study Results

Primary End Point (PFS)
47
%

Primary End Point (PFS)
62
%

Secondary End Points

Secondary End Point (OS)
28
%

Secondary End Point (OS)
34
%

Secondary End Point (OS)
43
%

Secondary End Point (ORR)
15.0%
21%
19%
5.0%
2%
0%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
Age <65 years Age, 65-74 years Age, >75 years
Response Rate
Cabozantinib Everolimus

Secondary End Point (Safety)
68.0%
75%
78%
60.0% 60% 58%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
Age <65 years Age, 65-74 years Age, >75 years
Safety
Cabozantinib Everolimus

Conclusion
• Cabozantinib improved PFS, OS and ORR
compared with Everolimus in previously treated
patients with advanced RCC, irrespective of age
group, supporting use in all age categories.
Proactive dose modification and supportive care
may help to mitigate AEs in older patients while
maintaining efficacy.

Study Results

Primary End Point (PFS)
47
%

Primary End Point (PFS)
33
%

Primary End Point (PFS)
78
%

Secondary End Points

Secondary End Point (OS)
34
%

Secondary End Point (OS)
44
%

Secondary End Point (ORR)
16.0%
19%
22%
3.0%
4%
0%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
Prior sunitinib Prior pazopanib Prior anti–PD-1/PD-
L1
Response Rate
Cabozantinib Everolimus

Secondary End Point (Safety)
67.0%
73%
83%
61.0% 62% 64%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
Prior sunitinib Prior pazopanib Prior anti–PD-1/PD-
L1
AE Grade 3 or 4
Cabozantinib Everolimus

Conclusion
• Cabozantinib was associated with improved
clinical outcomes versus Everolimus in patients
with advanced RCC, irrespective of prior therapy,
including checkpoint inhibitor therapy.

Study Overview
• In the phase III METEOR trial, 658 previously treated patients with
advanced renal cell carcinoma were randomly assigned 1:1 to receive
Cabozantinib or Everolimus. The Cabozantinib arm had improved
progression-free survival, overall survival, and objective response rate
compared with Everolimus. Changes in quality of life (QoL), an
exploratory end point, are reported here.

Study Results

Secondary End Point (QOL)
Functional Assessment of Cancer (FKSI (19-
item))

Secondary End Point (QOL)
Functional Assessment of Cancer Disease-Related Symptoms (FKSI-DRS
(nine-item)

Secondary End Point (QOL)
Effect of baseline FKSI-DRS on OS

Conclusion
• In patients with advanced renal cell carcinoma,
relative to Everolimus, Cabozantinib generally
maintained QoL to a similar extent. Compared
with Everolimus, Cabozantinib extended Time to
deterioration (TTD) overall and markedly
improved TTD in patients with bone metastases.

Original Article
Long-term follow-up of overall survival for
Cabozantinib versus Everolimus in advanced
renal cell carcinoma
Robert J. Motzer1, Bernard Escudier2, Thomas Powles3, Christian
Scheffold4 and Toni K. Choueiri
British Journal of Cancer
(2018) 118:1176–1178
26 March 2018

Study Results

Secondary End Point (OS)
30
%

Secondary End Point (Safety)
71.0%
61.0%
56.0%
58.0%
60.0%
62.0%
64.0%
66.0%
68.0%
70.0%
72.0%
AE 3 or 4
Safety
Cabozantinib Everolimus

Conclusions
• Cabozantinib significantly improved overall survival compared
with Everolimus in previously treated patients with advanced
RCC with consistent results after long-term follow-up.

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