GSK Bets on Outcome of Kidney Cancer Trial
GlaxoSmithKline is literally putting money on the outcome of a clinical trial now in progress, pitting its pazopanib (Votrient) for advanced renal cell carcinoma against sunitinib (Sutent).
In an effort to persuade the U.K.'s National Health Service to pay for pazopanib, which GSK has priced somewhat higher than sunitinib, the company has promised to rebate some of the NHS' expenditures for the drug if the ongoing trial shows that pazopanib is inferior to its rival.
The rebate would be in addition to a 12.5% discount off pazopanib's list price, which eliminates its premium over sunitinib.
Britain's National Institute for Health and Clinical Excellence (NICE), which provides guidances on medical technologies that the NHS nearly always follows, has recommended that the service accept the deal.
The study, called COMPARZ, began in 2008 and is expected to close data collection next May. Final results are expected in mid-2012.
Nearly 900 patients with locally advanced or metastatic renal cell carcinoma have been enrolled. The prespecified primary outcome is progression-free survival, with secondary measures that include overall survival, objective response rate, duration of response, and safety.
On the basis of existing studies, NICE determined that pazopanib would not be cost-effective unless GSK agreed to match sunitinib's retail price and provide the rebate if pazopanib turns out to be inferior in the head-to-head study.
Both drugs are oral inhibitors of tyrosine kinases associated with growth factors that promote tumor expansion. Sunitinib targets the vascular endothelial growth factor (VEGF) kinase, whereas pazopanib inhibits kinases for both VEGF and platelet-derived growth factor.
Studies have suggested that pazopanib has a better side effect profile, but the two drugs have not been compared directly before in a randomized trial.
NICE's guidance on the GSK deal did not specify the amount of the rebate that the company would pay if COMPARZ fails to demonstrate equality or superiority for pazopanib. It was among details provided to the agency "commercially in confidence," the guidance document said.
Dec 29, 2010