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Results from the phase II CABOSUN clinical trial, showing cabozantinib to be superior to sunitinib as first-line treatment for advanced kidney cancer, were presented at the European Society for Medical Oncology (ESMO) congress in Copenhagen this week.
CABOSUN is a phase II randomised controlled clinical trial comparing cabozantinib and sunitinib in previously untreated patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC). The study found that the median progression-free survival (PFS) — the study’s primary endpoint — was significantly longer in cabozantinib than sunitinib recipients (8.2 vs. 5.6 months). This was a 46% improvement in PFS with cabozantinib treatment. In addition, cabozantinib was associated with a clinically meaningful and statistically significant 31% decrease in the rate of disease progression or death.
The objective response rate also was significantly greater with cabozantinib than sunitinib (46% vs 18%), and median overall survival was 30.3 months for cabozantinib compared with 21.8 months for sunitinib.
Cabozantinib was approved by the European Medicines Agency (EMA) for use in Europe last month, and is currently being reviewed by the National Institute for Health and Care Excellence (NICE) for use in NHS England. The first NICE appraisal meeting for cabozantinib is scheduled for January 2017, and publication of their recommendation is expected in June 2017.