METEOR: A pivotal, phase 3, head-to-head, randomized controlled trial1-3
An open-label trial vs everolimus in advanced RCC after prior therapy*
- Tumor assessment every 8 weeks for the first 12 months, then every 12 weeks thereafter1
*Anti-angiogenic.
†Dose reductions were allowed in both arms.
‡The primary PFS analysis was conducted in the first 375 subjects randomized to treatment.
The ITT population included all 658 patients.
§Confirmed per IRRC.
Inclusion criteria1,2,5:
- Clear-cell component
- Measurable disease as defined by RECIST v1.1
- Radiographic progression within 6 months of enrollment
- Radiographic progression during treatment with a VEGFR-TKI or within 6 months of last dose
- No limit to the number of prior therapies
- Prior treatment with antibodies targeting PD-1/PD-L1/L2 allowed
- Brain metastases allowed if adequately treated and stable
- Karnofsky performance status ≥70%
Prespecified stratification1,2:
- MSKCC risk groups: favorable, intermediate, poor
- Number of prior VEGFR-TKIs: 1, ≥2
MSKCC=Memorial Sloan Kettering Cancer Center; PD-1=programmed cell death protein-1; PD-L1/L2=programmed death ligand-1/2; RECIST=Response Evaluation Criteria In Solid Tumors; TKI=tyrosine kinase inhibitor; VEGFR=vascular endothelial growth factor receptor.
METEOR evaluated a diverse set of patients who had received prior therapy1,2*
No. (%) | ||
CABOMETYX (n=330) |
everolimus (n=328) |
|
Median age (range) | 63 (56-68) | 62 (55-68) |
---|---|---|
Sex | ||
Male | 253 (77) | 241 (73) |
Female | 77 (23) | 86 (26) |
Geographic region | ||
Europe | 167 (51) | 153 (47) |
North America | 118 (36) | 122 (37) |
Asia-Pacific | 39 (12) | 47 (14) |
Latin America | 6 (2) | 6 (2) |
Ethnic origin | ||
White | 269 (82) | 263 (80) |
Asian | 21 (6) | 26 (8) |
Black | 6 (2) | 3 (<1) |
Other | 19 (6) | 13 (4) |
Not reported | 15 (5) | 22 (7) |
ECOG PS | ||
0 | 226 (68) | 217 (66) |
1 | 104 (32) | 111 (34) |
MSKCC prognostic risk category | ||
Favorable | 150 (45) | 150 (46) |
Intermediate | 139 (42) | 135 (41) |
Poor | 41 (12) | 43 (13) |
Metastatic site per IRRC | ||
Lung | 204 (62) | 212 (65) |
Liver | 88 (27) | 103 (31) |
Bone | 77 (23) | 65 (20) |
Lymph node | 206 (62) | 199 (61) |
Brain | 2 (<1) | 1 (<1) |
Other | 23 (7) | 21 (6) |
Previous VEGFR-TKIs | ||
1 | 235 (71) | 229 (70) |
≥2 | 95 (29) | 99 (30) |
Previous systemic therapy | ||
Sunitinib | 210 (64) | 205 (62) |
Pazopanib | 144 (44) | 136 (41) |
Axitinib | 52 (16) | 55 (17) |
Sorafenib | 21 (6) | 31 (9) |
Bevacizumab | 5 (2) | 11 (3) |
Interleukin 2 | 20 (6) | 29 (9) |
Interferon α | 19 (6) | 24 (7) |
Nivolumab|| | 17 (5) | 14 (4) |
Radiotherapy | 110 (33) | 108 (33) |
Nephrectomy | 283 (86) | 279 (85) |
Nearly half of patients in the METEOR trial had favorable-risk disease
Data are n (%) or median (IQR).
*Anti-angiogenic.
IIOne additional patient in the cabozantinib group received prior atezolizumab.2
ECOG=Eastern Cooperative Oncology Group; IRRC=independent radiology review committee; PS=performance status.
First and only TKI to demonstrate significant improvement across 3 endpoints—OS, PFS, and ORR—in advanced RCC after prior therapy1*
Significant survival advantage1
SECONDARY ENDPOINT: OS
- Nearly 5-month increase in median OS for patients taking CABOMETYX vs everolimus
- Sustained separation of the OS curve at 12 and 18 months (follow-up of at least 13 months)

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Results from the METEOR, second-line clinical trial
Read the publicationProven control of progression1,3
PRIMARY ENDPOINT: PFS¶
- 42% reduction in risk of progression or death vs everolimus
*Anti-angiogenic.
¶PFS was confirmed by IRRC.
HR=hazard ratio; OS=overall survival; ORR=objective response rate; PFS=progression-free survival; RCC=renal cell carcinoma.
Significantly improved tumor control1
SECONDARY ENDPOINT: ORR#**
#ORR was assessed by blinded IRRC using RECIST v1.1.3
**Partial responses only.1
Improved tumor control1,2
TUMOR RESPONSE AS ASSESSED BY IRRC
CABOMETYX (n=330) |
everolimus (n=328) |
||
ORR (95% CI)†† |
17% (13%-22%) | 3% (2%-6%) | Secondary endpoint2 P<0.0001 |
Best overall response, n (%) | |||
Confirmed complete response (CR) | 0 | 0 | |
Confirmed partial response (PR)‡‡ | 57 (17%) | 11 (3%) | |
Stable disease (SD)§§ | 216 (65%) | 203 (62%) | |
Progressive disease (PD)|||| | 41 (12%) | 88 (27%) | |
Not evaluable or missing¶¶ | 16 (5%) | 26 (8%) |
††The proportion of patients achieving an overall response of confirmed CR or PR per RECIST v1.1.2
‡‡PR is defined by RECIST v1.1 as ≥30% decrease in tumor size following study treatment.5
§§SD is defined by RECIST v1.1 as neither sufficient increase nor decrease in tumor size to qualify as PD or PR, respectively, following study treatment.5
||||PD is defined by RECIST v1.1 ≥20% relative increase and ≥5 mm absolute increase in tumor size following study treatment.The appearance of 1 or more new lesions is also considered progression.5
¶¶No qualifying postbaseline assessment for overall response.2
CABOMETYX safety in the METEOR study
ARs occurring in ≥10% of patients in the CABOMETYX arm1,4
Percentage (%) of Patients | ||||
ARs## | 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 | ||||
Palmar-plantar erythrodysesthesia | 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 |
Laboratory abnormalities occurring in ≥25% of patients in the CABOMETYX arm1
Percentage (%) of Patients | ||||
Test††† | 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 |
##Percentages are treatment-emergent, all-causality events.
***One subject randomized to everolimus received CABOMETYX.
†††NCI–CTCAE.
‡‡‡These ARs are grouped terms. For details, please see full Prescribing Information.
§§§Based on laboratory abnormalities
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyltransferase.

Helpful tips for management with CABOMETYX
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