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METEOR: a phase III trial of CABOMETYX® (cabozantinib) versus everolimus in advanced RCC

In the pivotal, phase III, METEOR study, the efficacy and safety of cabozantinib following prior vascular endothelial growth factor (VEGF)-targeted therapy was compared with everolimus in treatment for RCC.1, 9-11

View the METEOR study publication

 

Study Design

METEOR was a randomised, open-label phase III trial in adult patients with advanced or metastatic RCC who had previously received at least one prior VEGF receptor tyrosine kinase inhibitor. Patients could have received other prior therapies, including cytokines, and antibodies targeting VEGF, the programmed death 1 (PD-1) receptor, or its ligands.1

Patients (n=658) were randomised 1:1 to receive either cabozantinib 60 mg/day (n=330) or everolimus 10 mg/day (n=328).1,9  Random assignment to treatment was stratified by IMDC risk category (intermediate or poor) and presence of bone metastases (yes or no).1

The primary endpoint assessed in METEOR was PFS assessed by an independent radiology review committee (IRC). Secondary efficacy endpoints were OS and ORR. PFS was also assessed in the following prespecified subgroups: number of prior VEGFR inhibitor treatments (1 or ≥2) and Memorial Sloan Kettering Cancer Center (MSKCC) risk group (favourable, intermediate or poor).1

Design of the METEOR phase III trial

ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RCC, renal cell carcinoma. IRC, independent radiology review committee

Adapted from SmPC1

View References →

Study Design

Patient Population

Eligible patients were:

  • Age ≥18 years
  • Advanced or metastatic RCC with a clear-cell component
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
  • Prior treatment with ≥1 VEGFR inhibitor
  • Radiographic progression during treatment or ≤6 months after the most recent dose of VEGFR inhibitor and ≤6 months before randomisation
  • Brain metastases allowed if adequately treated and stable
  • Karnofsky performance score of ≥70%
  • Adequate organ and marrow function

Patients were excluded if they met the following criteria:1,9

  • Previous mTOR inhibitor therapy, including everolimus
  • Uncontrolled hypertension or clinically significant cardiovascular, gastrointestinal, wound healing, or infectious comorbidities

The patient demographic and baseline characteristics were typical of patients with advanced RCC who require second-line treatment and balanced between the cabozantinib and everolimus treatment arms.1

Patient demographic and baseline characteristics in the METEOR phase III trial

Characteristic

Cabozantinib

(n=330)

Everolimus

(n=328)

Gender, n (%)
Male 253 (77) 241 (73)
Female 77 (23) 86 (26)
Age, years
Median 63 62
Range 56-68 55-68
MSKCC prognostic risk category, n (%)
Favourable 150 (45) 150 (46)
Intermediate 139 (42) 135 (41)
Poor 41 (12) 43 (13)
Prior VEGFR TKI, n (%)
1 235 (71) 229 (70)
≥2 95 (29) 99 (30)
Prior systemic therapy
Sunitinib 210 (65) 205 (62)
Pazopanib 144 (44) 136 (41)
Axitinib 52 (16) 55 (17)
Sorafenib 21 (6) 31 (9)
Bevacizumab 5 (2) 11 (3)
IL-2 20 (6) 29 (9)
IFNa 19 (6) 24 (7)
Nivolumab 17 (5) 14 (4)

IFN-α, Interferon-alpha; IL-2, interleukin-2; MKSCC, Memorial Sloan Kettering Cancer Center; TKI, tyrosine kinase inhibitor; VEGFR, vascular endothelial growth factor receptors

Adapted from Choueiri TK, et al. 201610

View References →

Patient Population

Key Efficacy Results

IRC-assessed PFS (Primary) in the METEOR phase III trial

Cabozantinib demonstrated significantly improved median PFS vs. everolimus: 7.4 months for cabozantinib vs. 3.8 months for everolimus (HR: 0.58; 95% CI: 0.45-0.74; p<0.0001).

Primary endpoint: PFS in the METEOR phase III trial (first 375 patients randomized)*

*As assessed by an independent radiology review committee10

Adapted from SmPC1

PFS results for the prespecified subgroups of the number of prior VEGFR inhibitor treatments and MSKCC risk group were consistent with those of the overall population.10

PFS in the intent-to-treat population (n=658) showed similar results, with median PFS of 7.4 months for cabozantinib and 3.9 months for everolimus (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001).1

OS

OS was statistically significantly increased in patients treated with cabozantinib vs. everolimus: 21.4 months for cabozantinib vs. 16.5 months for everolimus (HR: 0.66; 95% CI: 0.53-0.83; p=0.0003).1

A similar result was reported in the long-term follow-up of patients from the METEOR trial (minimum duration of 22 months): 21.4 months for cabozantinib vs. 17.1 months for everolimus (HR: 0.70; 95% CI: 0.58-0.85; p=0.0002).11

OS in the long-term* follow-up of the METEOR phase III trial

*Minimum duration of follow-up was 22 months

OS, overall survival

Adapted from Motzer RJ, et al.201811

ORR

A significantly greater number of patients had an objective response as assessed by an independent radiology review committee when treated with cabozantinib compared with everolimus: 17% (n=57) for cabozantinib vs. 3% (n=11) for everolimus (p<0.0001).1

ORR in the METEOR phase III trial

IRC, independent radiology review committee; ORR, objective response rate

Adapted from SmPC1

View References →

Key Efficacy Results

Safety Results

Please see the ‘What are the adverse events of CABOMETYX®?’ and ‘What are the dosing recommendations for CABOMETYX®?’ sections of this website.

Please also refer to the CABOMETYX® Summary of Product Characteristics for a full list of adverse events and dose reduction recommendations.

For further information on the METEOR trial, please refer to full published clinical papers.1,9-11

View References →

 

Safety Results

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