Cabozantinib superior to sunitinib in phase II study of metastatic RCC

Compared with sunitinib, first-line cabozantinib significantly improved progression-free survival (PFS) and objective response rate (ORR) in patients with metastatic renal cell carcinoma (mRCC).

Compared with sunitinib, first-line cabozantinib significantly improved progression-free survival (PFS) and objective response rate (ORR) in patients with metastatic renal cell carcinoma (mRCC). These were the conclusions of a randomised, multicentre phase II trial reported in a Late-Breaking Abstract presentation yesterday by Dr Toni Choueiri from the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, Boston, Massachusetts, USA (Abstract LBA30_PR).

Cabozantinib has recently shown superior PFS, overall survival and ORR compared with everolimus in previously treated patients with mRCC,1 while sunitinib is considered the reference standard of care for the first-line treatment of mRCC.2

In the phase II ALLIANCE study, 157 intermediate- or poor-risk patients who had not received prior systemic therapy were randomised to cabozantinib (60 mg once daily [qd]) or sunitinib (50 mg qd, 4 weeks on/2 weeks off). Median PFS (primary endpoint) was considerably prolonged with cabozantinib compared with sunitinib (8.2 months versus 5.6 months, respectively), equivalent to a 31% reduction in median rate of progression or death with cabozantinib (hazard ratio 0.69; 95% confidence interval 0.48–0.98; p=0.012) at a median follow-up of 20.8 months. ORR was also markedly and significantly higher with cabozantinib (46%) versus sunitinib (18%). Adverse events (AEs) were reported at a similar incidence in the cabozantinib and sunitinib treatment arms (70.5% and 72.2% of patients, respectively, experienced grade ≥3 AEs).

This randomised, phase II trial has demonstrated for the first time superior activity of a new therapy compared with sunitinib in previously untreated patients with RCC.

  1. Choueiri T, et al. N Engl J Med 2015;373:1814–23
  2. Oudard S, et al. Cancer Treat Rev 2011;37:178–84

“These data show that cabozantinib has the potential to become a first-line standard treatment for mRCC,” concluded Dr Choueiri.

This article appeared in the Tuesday edition of the Daily Reporter