GSK Phase III mRCC study meets primary endpoint

2nd October 2012 (Last Updated October 2nd, 2012 18:30)

GlaxoSmithKline (GSK) has announced that its COMPARZ Phase III study of Votrient (pazopanib) vs sunitinib in advanced renal cell carcinoma (mRCC) has met its primary endpoint.

GSK

GlaxoSmithKline (GSK) has announced that its COMPARZ Phase III study of Votrient (pazopanib) vs sunitinib in advanced renal cell carcinoma (mRCC) has met its primary endpoint.

The open-label study reported that pazopanib demonstrated non-inferiority to sunitinib in terms of progression free survival.

GSK Oncology president Dr Paolo Paoletti said the company is looking forward to sharing the findings with the physicians who treat advanced renal cell carcinoma.

"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," Paoletti said.

The study randomised 1,110 patients with either pazopanib or sunitinib at their respective approved treatment doses.

An independent review indentified that the Votrient vs sunitinib hazard ratio for PFS was 1.047, while predefined criterion for non-inferiority was the upper bound of a two-sided 95% CI of 1.25.

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

An objective response rate of 31% in the pazopanib arm, compared to 25% in the sunitinib arm, was observed as the secondary endpoint.

Analysis of overall survival data showed that the Votrient vs sunitinib hazard ratio was 0.908 (95% CI 0.762, 1.082; p-value = 0.275).

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

The most common adverse events include diarrhoea, fatigue, hypertension, nausea, decreased appetite, ALT increase, hair colour changes, hand-foot syndrome, taste alteration and thrombocytopenia.

42% of patients in the pazopanib arm and 41% in the sunitinib arm had serious adverse events.


Image: GlaxoSmithKline's headquarters in London, UK. Photo: Courtesy of Maxwell Hamilton.