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‡

    See our Clinical Guideline Recommendations  >

*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.

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Clinical guidelines recommend CABOMETYX as a "preferred" regimen

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CABOMETYX 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

OS (Overall Survival); Secondary Endpoint in CABOSUN
ORR in CABOSUN; Secondary Endpoint 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.

VIEW CABOSUN STUDY DESIGN AND PATIENT CHARACTERISTICS

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Results from the CABOSUN, first-line vs TKI, clinical trial

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CABOMETYX 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

Median PFS (Progression Free Survival); Primary Endpoint in METEOR

SECONDARY ENDPOINT IN METEOR

ORR 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

VIEW METEOR STUDY DESIGN AND PATIENT CHARACTERISTICS
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Exelixis Access Services® (EASE) enrollment form, including the 15-Day Free Trial Program, EASE Quick Start Program, EASE Co-Pay Program, and the EASE Patient Assistance Program (PAP)

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Results from the METEOR, second-line clinical trial

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No 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.

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Helpful tips for management with CABOMETYX

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Additional details around dosing and administration

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ARs 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®)

 

NCCN Preferred

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.

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NEXT: HCC SECOND-LINE DATA
 

INDICATIONS

CABOMETYX® (cabozantinib) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

CABOMETYX® (cabozantinib) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: GastrointestinaI (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula that cannot be appropriately managed or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 28 days prior to scheduled dental surgery or invasive dental procedures. Withhold CABOMETYX for development of ONJ until complete resolution.

Wound Complications: Wound complications were reported with CABOMETYX. Stop CABOMETYX at least 28 days prior to scheduled surgery. Resume CABOMETYX after surgery based on clinical judgment of adequate wound healing. Withhold CABOMETYX in patients with dehiscence or wound healing complications requiring medical intervention.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information.

References: 1. Data on file. Exelixis, Inc. IQVIA National Prescription Audit®, April 2019. 2. CABOMETYX® (cabozantinib) Prescribing Information. Exelixis, Inc, 2019. 3. US Food and Drug Administration. [email protected]: FDA approved drug products (CABOMETYX). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208692. Accessed May 7, 2019. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.2.2020. ©National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed August 14, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. 5. Choueiri TK, Hessel C, Halabi S, et al. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): progression-free survival by independent review and overall survival update. Eur J Cancer. 2018;94:115-125. 6. Data on file. Exelixis, Inc. 7. Choueiri T, Halabi S, Sanford, B, et al. Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the Alliance A031203 CABOSUN trial. J Clin Oncol. 2017;35(6):591-597. doi:10.1200/JCO.2016.70.7398. 8. Heng DYC, Xie W, Regan MM, et al. External validation and comparison with other models of the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model: a population-based study. Lancet Oncol. 2013;14(2):141-148. doi:10.1016/S1470-2045(12)70559-4. 9. Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016;17(7):917-927. doi:10.1016/S1470-2045(16)30107-3. 10. Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373(19):1814-1823. doi:10.1056/NEJMoa1510016.

CABOMETYX now #1 TKI in new prescriptions for aRCC