Clinical Efficacy

SUTENT® demonstrates consistently proven first-line efficacy in head-to-head, Phase III trials.2–4

Adapted from Motzer RJ, et al. 2009. Motzer RJ, et al. 2013. Rini BI, et al. 2015. No cross-trial comparisons may be made, since trials were conducted using different methodologies and at different time points.
*mOS not reached.

SUTENT® outcomes improve with experience: mOS has progressively increased over time2–4,5

Study Information

Registration trial

  • Randomised, multicentre, Phase III trial in 750 treatment-naïve patients with mRCC, comparing the efficacy and safety of SUTENT® 50 mg/day on a 4/2 schedule and IFN-α 9 MU SC TIW.2,6

COMPARZ

  • Randomised Phase III trial in 1110 mRCC patients, comparing SUTENT® and pazopanib as first-line therapy.3

IMPRINT

  • Randomised, open-label, Phase III trial in 339 mRCC patients, investigating IMA901 plus SUTENT® versus SUTENT® as a monotherapy as a first line treatment.4

In the Phase III randomised first-line mRCC trial vs. IFN-α, SUTENT® demonstrated a 6-month improvement in mPFS.2,6

metastatic-renal-cell-carcinoma-mrcc-clinical-efficacy

Adapted from Motzer RJ, et al. 2007.

In the Phase III randomised first-line mRCC trial vs. IFN-α, SUTENT® achieved more than 2 years mOS.2

Adapted from Motzer RJ, et al. 2009.

Phase III, international randomised controlled trial evaluating SUTENT® vs. IFN-α.2

Based on the pivotal Phase III trial study, the recommended starting dose of SUTENT® is 50 mg daily given on a 4/2 treatment schedule.

Adapted from Motzer RJ, et al. 2009.

CI, confidence interval. HR, hazard ratio. IFN-α. interferon-alpha. ITT, intent to treat. mOS, median overall survival. mPFS, median progression-free survival. mRCC, metastatic renal cell carcinoma. MU, million units. OS, overall survival. PFS, progression-free survival. SC, subcutaneous. TIW, three times weekly.

References:

  1. SUTENT® Summary of Product Characteristics. 
  2. Motzer RJ, et al. J Clin Oncol 2009;27:3584–3590.
  3. Motzer RJ, et al. N Engl J Med 2013;369:722–731.
  4. Rini BI, et al. ECC. 25-29 September 2015. Vienna, Austria. Abstract: 17LBA.
  5. Motzer RJ, et al. J Clin Oncol 2014;32:2765–2772.
  6. Motzer RJ, et al. N Engl J Med 2007;356:115–124.

PP-SUT-IRL-0137  September 2020