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CABOSUN was a randomised, open-label multicenter phase II trial supported by grants from the National Institutes of Health and run independently of Ipsen. The study compared the efficacy and safety of cabozantinib with sunitinib as initial targeted therapy in adult patients with metastatic RCC of intermediate or poor risk, as defined by International Metastatic RCC Database Consortium (IMDC) criteria.1,7
Patients (n=157) were randomised 1:1 to receive either cabozantinib 60 mg/day (n=79) or sunitinib 50 mg/day, 4 weeks on, 2 weeks off (n=78). Random assignment to treatment was stratified by IMDC risk category (intermediate or poor) and presence of bone metastases (yes or no) using the dynamic allocation method.1,7
The primary endpoint of the CABOSUN trial was investigator-assessed PFS. Secondary endpoints were overall survival (OS), investigator-assessed objective response rate (ORR) and safety. PFS, ORR and best change in tumour target lesions by independent review were post-hoc retrospective analyses which were initiated after analysis of the primary endpoint.1,7
Design of the CABOSUN phase II trial
IMDC, International Metastatic RCC Database Consortium; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RCC, renal cell carcinoma
Adapted from SmPC1 and Choueiri TK, et al. 20177
Eligible patients were:
The patient demographic and baseline characteristics were similar between the cabozantinib and sunitinib treatment arms.1
Patient demographic and baseline characteristics in the CABOSUN phase II trial
|Gender, n (%)|
|Male||66 (84)||57 (73)|
|Female||13 (16)||21 (27)|
|IMDC risk group, n (%)|
|Intermediate||64 (81)||63 (81)|
|Poor||15 (19)||15 (19)|
|Bone metastases, n (%)|
|Yes||29 (37)||28 (36)|
|No||50 (63)||50 (64)|
|Yes||57 (72)||60 (77)|
|No||22 (28)||18 (23)|
|0||36 (46)||36 (46)|
|1||33 (42)||32 (41)|
|2||10 (13)||10 (13)|
ECOG PS, Eastern Cooperative Oncology Group performance score; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium
Adapted from Choueiri TK, et al. 20177
Cabozantinib demonstrated significantly improved median PFS vs. sunitinib: 8.3 months for cabozantinib vs. 5.4 months for sunitinib (adjusted HR for progression or death: 0.56; 95% CI: 0.37-0.83; p=0.0042).1
A statistically significant improvement in PFS as retrospectively assessed by a blinded Independent Radiology Committee (IRC) was demonstrated for cabozantinib compared to sunitinib (8.6 months for cabozantinib vs 5.3 months for sunitinib). Aadjusted HR for progression or death: 0.48; 95% CI: 0.32-0.73; p=0.0005.1
The primary endpoint was investigator-assessed PFS. Secondary efficacy endpoints were objective response rate (ORR) and overall survival (OS). Tumor assessments were conducted every 12 weeks.
IRC-assessed PFS in the CABOSUN phase II trial (exploratory)*
This was a retrospective, exploratory analysis conducted by an independent radiology review committee involving all 157 randomised patients.
Adapted from SmPC1
PFS results for the prespecified subgroups of IMDC risk groups and presence or absence of bone metastases were consistent with those of the overall population.7
The study was not powered for the OS analysis and the data are immature. Cabozantinib treatment was associated with a trend for longer survival compared to sunitinib: 30.3 vs 21.0 months, adjusted HR: 0.74; 95% CI: 0.47-1.14).
A greater number of patients had an investigator-assessed ORR when treated with cabozantinib (n=79) compared with sunitinib (n=78): 33% (n=26) for cabozantinib vs. 12% (n=9) for sunitinib.1
Similar ORR results were reported in a retrospective, exploratory analysis conducted by the IRC; 20% (n=16) for cabozantinib vs. 9% (n=7) for sunitinib.1
ORR in the CABOSUN phase II trial
IRC, Independent radiology review committee; ORR, objective response rate
Adapted from SmPC1
Key efficacy 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 CABOSUN trial, please refer to full published clinical papers.7,8