Pharmaceutical Business review

GSK Phase III COMPARZ study meets primary endpoint

The pazopanib demonstrated non-inferiority to sunitinib in terms of progression free survival (PFS) in the head-to-head study.

GSK Oncology president Paolo Paoletti said, "There has been limited information on the direct comparison of therapeutic agents such as pazopanib and sunitinib and we undertook the study in hopes of providing insights that will support the treatment decisions physicians make."

The patients with advanced renal cell carcinoma were treated with either pazopanib or sunitinib at their respective, approved treatment doses (pazopanib – 800mg/daily; sunitinib – 50 mg/daily for four weeks followed by two weeks off treatment) in the study.

Based on independent review data, COMPARZ showed that the Votrient vs sunitinib hazard ratio for PFS was 1.047, predefined criterion for non-inferiority was the upper bound of a two-sided 95% CI of 1.25.

According to the study data, Median PFS was 8.4 months for pazopanib compared to sunitinib at 9.5 months.

The secondary endpoint of objective response rate showed an ORR of 31% in the pazopanib arm compared to 25% in the sunitinib arm. The overall survival data analysis demonstrated that the Votrient vs sunitinib hazard ratio for OS was 0.908.

A statistically significant outcome was observed in favour of pazopanib for 11 of the 14 domains from four Quality of Life instruments.

The most common adverse events in the study for pazopanib compared to sunitinib, respectively, included diarrhea, fatigue, hypertension, nausea, decreased appetite, ALT increase, hair color changes, hand-foot syndrome, taste alteration and thrombocytopenia.