Tuesday, October 2, 2012

Pazopanib (Votrient) comparable to Sunitinb (Sutent) in first line Advanced Renal Cell Carcinoma

The Phase 3 COMPARZ Study, compared treatment with GSK's Pazopanib (Votrient) to Pfizer's Sunitinib (Sutent) in patients with advanced renal cell carcinoma (clear cell histology). The two drugs were comparable on the overall survival benefit. Patients treated with Pazopanib had a median OS of 28.4 months (95% CI 26.2-35.6), while patients treated with Sunitinib had a median OS of 29.3 months.


The median PFS was 8.4 months (95% CI 8.3- 10.9) in the pazopanib arm and 9.5 months (95% CI 8.3-11.1) in the sunitinib arm. Pazopanib was shown to be non-inferior to sunitinib for PFS, as the upper bound of the two-sided 95% CI of the hazard ratio fell below 1.25 (HR 1.047; 95% CI 0.898 to 1.220).


The most common adverse events for pazopanib compared to sunitinib, respectively, included: diarrhoea (63% vs. 57%); fatigue (55% vs. 63%); hypertension (46% vs. 41%); nausea (45% vs. 46%); decreased appetite (37% vs. 37%); ALT increase (31% vs. 18%); hair colour changes (30% vs. 10%); hand-foot syndrome (29% vs. 50%); taste alteration (26% vs. 36%); and, thrombocytopenia (10% vs. 34%). Serious adverse events occurring in 3% or more of patients included ALT and AST increase in the pazopanib arm and pyrexia and thrombocytopenia in the sunitinib arm.