BioCentury
ARTICLE | Clinical News

Votrient pazopanib: Phase III data

November 5, 2012 8:00 AM UTC

GlaxoSmithKline reported data from the open-label, international Phase III COMPARZ trial in 1,110 patients with locally advanced and/or metastatic RCC who have received no prior systemic therapy showing that once-daily 800 mg Votrient met the primary endpoint of non-inferiority to once-daily 50 mg Sutent sunitinib in median PFS (8.4 vs. 9.5 months). The PFS hazard ratio was 1.047 (95% CI: 0.898, 1.22), with the upper bound of the 95% CI within the pre-specified non-inferiority margin of 1.25. On secondary endpoints, Votrient significantly improved ORR vs. Sutent (31% vs. 25%, p=0.032). There was no significant difference between Votrient and Sutent in median OS (28.4 vs. 29.3 months, HR=0.908, 95% CI: 0.762, 1.082, p=0.275). Additionally, Votrient significantly improved 11 of 14 domains from 4 quality of life instruments, which included measures of fatigue, mouth and throat soreness, vs. Sutent. Data were presented at the European Society for Medical Oncology meeting in Vienna. ...