VOTRIENT—Differentiated safety profile from sunitinib in COMPARZ1

Grade 3/4 adverse events (AEs) differed with sunitinib

Treatment-emergent AEs in >10% of patients in COMPARZ

  • Median treatment duration was similar for VOTRIENT (8.0 months; range, 0 months-40 months) and sunitinib (7.6 months; range, 0 months-38 months). Dose interruption of 7 days or more was similar for VOTRIENT (44%) and sunitinib (49%). Dose reduction was similar for VOTRIENT (44%) and sunitinib (51%). The percentage of patients who discontinued study drug because of AEs was 24% for VOTRIENT and 20% for sunitinib. The higher discontinuation rate observed for VOTRIENT was primarily due to abnormalities in liver function tests (6% vs 1%)
  • In COMPARZ, patients had baseline and follow-up LVEF measurements. Myocardial dysfunction occurred in 13% of patients receiving VOTRIENT compared with 11% of patients receiving sunitinib. Congestive heart failure was observed in 0.5% of patients in each treatment group1,2

The difference in relative risk was considered significant when the 95% CI did not include unity. These CIs were not corrected for multiple comparisons.
*The relative risk of an event of any grade was significantly higher with sunitinib than with VOTRIENT.
The relative risk of a grade 3/4 event was significantly higher with sunitinib than with VOTRIENT.
The relative risk of an event of any grade was significantly higher with VOTRIENT than with sunitinib.

Grade 3/4 laboratory abnormalities differed with sunitinib

Laboratory abnormalities showing significant difference in relative risk in COMPARZ

The difference in relative risk was considered significant when the 95% CI did not include unity. These CIs were not corrected for multiple comparisons.
*The relative risk of an event of any grade was significantly higher with sunitinib than with VOTRIENT (except for hypomagnesemia).
The relative risk of a grade 3/4 event was significantly higher with sunitinib than with VOTRIENT.
The relative risk of an event of any grade was significantly higher with VOTRIENT than with sunitinib.
§The relative risk of a grade 3/4 event was significantly higher with VOTRIENT than with sunitinib.

References: 1. Motzer RJ, Hutson TE, Cella D, et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013;369(8):722-731. 2. VOTRIENT [summary of product characteristics]. Camberley, UK: Novartis Europharm Limited; February 2018.