CABOMETYX is the only TKI with:
- 2 FDA approvals in aRCC based on 2 head-to-head, randomized trials2,3
- Superior efficacy in both 1L and 2L aRCC:
- NCCN "preferred" recommendations for cabozantinib, a single-agent TKI, in both 1L and 2L clear cell aRCC4‡
*Patients had ≥1 IMDC risk factors.2
†After at least 1 prior anti-angiogenic therapy.2
‡The 1L “preferred” recommendation is specific to intermediate/poor risk patients.4
aRCC=advanced renal cell carcinoma; FDA=US Food and Drug Administration; IMDC=International Metastatic Renal Cell Carcinoma Database Consortium; NCCN®=National Comprehensive Cancer Network®; PFS=progression-free survival; ORR=objective response rate; OS=overall survival; TKI=tyrosine kinase inhibitor.

Clinical guidelines recommend CABOMETYX as a "preferred" regimen
Find out moreCABOMETYX is the only TKI with superior efficacy to sunitinib2*
PRIMARY ENDPOINT IN CABOSUN: PFS†
CABOSUN was a randomized (1:1), open-label, multicenter trial in 157 first-line patients with aRCC who had ≥1 IMDC risk factors.2
SECONDARY ENDPOINTS IN CABOSUN
- ORR was assessed by a retrospective blinded IRRC and all responses were partial responses2
- The trial did not have a prespecified hypothesis for OS and ORR, and statistical testing of these endpoints was not performed5
*Patients had ≥1 IMDC risk factors.2
†PFS was assessed by a retrospective blinded IRRC.2
CI=confidence interval; HR=hazard ratio; IRRC=independent radiology review committee.

Results from the CABOSUN, first-line vs TKI, clinical trial
Read the publicationCABOMETYX is the only TKI with superior OS in 2L aRCC2*
SECONDARY ENDPOINT IN METEOR: OS
METEOR was a randomized (1:1), open-label, phase 3 trial in 658 patients with aRCC who had previously received at least one prior anti-angiogenic treatment.2,9
PRIMARY ENDPOINT IN METEOR
SECONDARY ENDPOINT IN METEOR
CABOMETYX is the only TKI with superior OS, PFS, and ORR in 2L aRCC2*
*After at least 1 prior anti-angiogenic therapy.2
†The primary PFS analysis was conducted in the first 375 subjects randomized to treatment. The ITT population included all 658 patients.2
‡PFS was confirmed by IRRC.2
§ORR was assessed by blinded IRRC using RECIST v1.1.9

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Results from the METEOR, second-line clinical trial
Read the publicationNo new safety signals were observed between the CABOSUN and METEOR trials2
- The CABOSUN safety profile was generally consistent with that of the initial CABOMETYX product approval, which was supported by results from the METEOR trial
GRADE 3-4 ARs OCCURRING IN >1% PATIENTS WHO RECEIVED CABOMETYX IN CABOSUN2*
No. (%) | ||
CABOMETYX (n=78) | sunitinib (n=72) | |
PATIENTS WITH ANY GRADE 3-4 AR | 53 (68) | 47 (65) |
Gastrointestinal | ||
Diarrhea | 8 (10) | 8 (11) |
Stomatitis | 4 (5) | 4 (6) |
Nausea | 2 (3) | 3 (4) |
General | ||
Fatigue | 5 (6) | 12 (17) |
Pain | 4 (5) | 0 |
Metabolism and Nutrition | ||
Decreased appetite | 4 (5) | 1 (1) |
Dehydration | 3 (4) | 1 (1) |
Skin and Subcutaneous Tissue | ||
PPE | 6 (8) | 3 (4) |
Skin ulcer | 2 (3) | 0 |
Vascular | ||
Hypertension† | 22 (28) | 15 (21) |
Hypotension | 4 (5) | 1 (1) |
Investigations | ||
Weight decreased | 3 (4) | 0 |
Nervous System | ||
Syncope | 4 (5) | 0 |
Psychiatric | ||
Depression | 3 (4) | 0 |
Infections | ||
Lung infection | 3 (4) | 0 |
Musculoskeletal and Connective Tissue | ||
Back pain | 3 (4) | 0 |
Bone pain | 2 (3) | 1 (1) |
Pain in extremity | 2 (3) | 0 |
Renal and Urinary | ||
Renal failure acute | 3 (4) | 1 (1) |
*National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0).2
†Includes the following term: hypertension.2
- The following Grade 3-4 ARs were seen in 1% of patients receiving CABOMETYX: dyspnea (vs 6% with sunitinib), anemia (vs 3% with sunitinib), vomiting (vs 3% with sunitinib), angiopathy (vs 1% with sunitinib), confusional state (vs 1% with sunitinib), arthralgia (vs 0% with sunitinib), constipation (vs 0% with sunitinib), and dysphonia (vs 0% with sunitinib)
LABORATORY-RELATED GRADE 3-4 ARS OCCURRING IN ≥1% PATIENTS WHO RECEIVED CABOMETYX IN CABOSUN2‡
No. (%) | ||
CABOMETYX (n=78) | sunitinib (n=72) | |
Metabolism and Nutrition | ||
---|---|---|
Hyponatremia | 7 (9) | 6 (8) |
Hypophosphatemia | 7 (9) | 5 (7) |
Hypocalcemia | 2 (3) | 0 |
Hypomagnesemia | 2 (3) | 0 |
Hyperkalemia | 1 (1) | 2 (3) |
Investigations | ||
Increased ALT | 4 (5) | 0 |
Increased AST | 2 (3) | 2 (3) |
Increased blood creatinine | 2 (3) | 2 (3) |
Lymphopenia | 1 (1) | 4 (6) |
Thrombocytopenia | 1 (1) | 8 (11) |
Renal and Urinary | ||
Proteinuria | 2 (3) | 1 (1) |
ARs were graded according to NCI–CTCAE v4.0.
‡Laboratory abnormalities are reported as ARs and not based on shifts in laboratory values.2
ALT=alanine aminotransferase; AR=adverse reaction; AST=aspartate aminotransferase; PPE=palmar-plantar erythrodysesthesia.

Helpful tips for management with CABOMETYX
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Additional details around dosing and administration
Download the guideARs OCCURRING IN ≥10% OF PATIENTS IN THE CABOMETYX ARM IN METEOR2
Percentage (%) of Patients | ||||
CABOMETYX (n=331)* | everolimus (n=322) | |||
All Grades† | Grade 3-4 | All Grades† | Grade 3-4 | |
Gastrointestinal | ||||
Diarrhea | 74 | 11 | 28 | 2 |
Nausea | 50 | 4 | 28 | <1 |
Vomiting | 32 | 2 | 14 | <1 |
Stomatitis | 22 | 2 | 24 | 2 |
Constipation | 25 | <1 | 19 | <1 |
Abdominal pain‡ | 23 | 4 | 13 | 2 |
Dyspepsia | 12 | <1 | 5 | 0 |
General | ||||
Fatigue | 56 | 9 | 47 | 7 |
Mucosal inflammation | 19 | <1 | 23 | 3 |
Asthenia | 19 | 4 | 16 | 2 |
Metabolism and Nutrition | ||||
Decreased appetite | 46 | 3 | 34 | <1 |
Skin and Subcutaneous Tissue | ||||
PPE | 42 | 8 | 6 | <1 |
Rash‡ | 23 | <1 | 43 | <1 |
Dry skin | 11 | 0 | 10 | 0 |
Vascular | ||||
Hypertension‡ | 39 | 16 | 8 | 3 |
Investigations | ||||
Weight decreased | 31 | 2 | 12 | 0 |
Nervous System | ||||
Dysgeusia | 24 | 0 | 9 | 0 |
Headache | 11 | <1 | 12 | <1 |
Dizziness | 11 | 0 | 7 | 0 |
Endocrine | ||||
Hypothyroidism | 21 | 0 | <1 | <1 |
Respiratory, Thoracic, and Mediastinal | ||||
Dysphonia | 20 | <1 | 4 | 0 |
Dyspnea | 19 | 3 | 29 | 4 |
Cough | 18 | <1 | 33 | <1 |
Blood and Lymphatic | ||||
Anemia | 17 | 5 | 38 | 16 |
Musculoskeletal and Connective Tissue | ||||
Pain in extremity | 14 | 1 | 8 | <1 |
Muscle spasms | 13 | 0 | 5 | 0 |
Arthralgia | 11 | <1 | 14 | 1 |
Renal and Urinary | ||||
Proteinuria | 12 | 2 | 9 | <1 |
*One subject randomized to everolimus received CABOMETYX.
†National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0).2
‡These ARs are grouped terms. For details, please see full Prescribing Information.2
LABORATORY ABNORMALITIES OCCURRING IN ≥25% OF PATIENTS IN THE CABOMETYX ARM IN METEOR2
Percentage (%) of Patients | ||||
CABOMETYX (n=331) | everolimus (n=322) | |||
All Grades | Grade 3-4 | All Grades | Grade 3-4 | |
Chemistry | ||||
---|---|---|---|---|
Increased AST | 74 | 3 | 40 | <1 |
Increased ALT | 68 | 3 | 32 | <1 |
Increased creatinine | 58 | <1 | 71 | 0 |
Increased triglycerides | 53 | 4 | 73 | 13 |
Hypophosphatemia | 48 | 8 | 36 | 5 |
Hyperglycemia | 37 | 2 | 59 | 8 |
Hypoalbuminemia | 36 | 2 | 28 | <1 |
Increased ALP | 35 | 2 | 29 | 1 |
Hypomagnesemia | 31 | 7 | 4 | <1 |
Hyponatremia | 30 | 8 | 26 | 6 |
Increased GGT | 27 | 5 | 43 | 9 |
Hematology | ||||
Leukopenia | 35 | <1 | 31 | <1 |
Neutropenia | 31 | 2 | 17 | <1 |
Anemia§ | 31 | 4 | 71 | 17 |
Lymphopenia | 25 | 7 | 39 | 12 |
Thrombocytopenia | 25 | <1 | 27 | <1 |
§Based on laboratory abnormalities.2
ALP=alkaline phosphatase; GGT=gamma-glutamyltransferase.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommendation4
National Comprehensive Cancer Network® (NCCN®)
1 L
Cabozantinib (CABOMETYX) is THE ONLY NCCN "PREFERRED" SINGLE-AGENT TKI option for 1L intermediate/poor risk clear cell aRCC4
2 L
Cabozantinib (CABOMETYX) is THE ONLY NCCN "PREFERRED" SINGLE-AGENT TKI option for 2L clear cell aRCC4
As defined by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), preferred interventions are based on superior efficacy, safety, and evidence; and when appropriate, affordability.
The only single-agent TKI with a “preferred” recommendation in both 1L intermediate/poor risk and 2L clear cell aRCC4
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.