NICE has recommended cabozantinib as a therapeutic option for adults with untreated advanced intermediate‑ or poor‑risk renal cell carcinoma (RCC).
The decision is based on clinical effectiveness evidence from the phase 2 CABOSUN trial comparing cabozantinib 60 mg per day orally with sunitinib 50 mg per day orally for four weeks (followed by a two-week break) in 157 patients. Although CABOSUN was not designed to be a registration trial, it was submitted to the regulators because the results were “encouraging”, according to the company.
In the study, cabozantinib was associated with increased median progression‑free survival (PFS) compared with sunitinib (8.3 mo vs 5.4 mo; HR 0.56; 95% CI 0.37-0.83; P=0.0042). Although overall survival was a secondary outcome in the trial, up to the cut-off date of July 2017, median overall survival was 26.6 months with cabozantinib compared with 21.2 months with sunitinib (HR 0.80; 95% CI 0.53-1.21; P=0.29). However, the committee concluded that cabozantinib did not meet the criteria for short life expectancy.
Cabozantinib was associated with treatment-related adverse events in 95% of patients vs 97% with sunitinib. Related grade 3 or 4 adverse events occurred in 60% and 63% respectively.
