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October 1, 2012updated 09 Sep 2022 12:46pm

GSK announces endpoint results of phase III renal cell carcinoma COMPARZ trial

GlaxoSmithKline (GSK) has announced the endpoint results of its pivotal phase III COMPARZ trial comparing renal cell carcinoma (aRCC) drugs paZopanib and sunitinib.

By Heidi Vella

GSK

GlaxoSmithKline (GSK) has announced the endpoint results of its pivotal phase III COMPARZ trial comparing renal cell carcinoma (aRCC) drugs paZopanib and sunitinib.

The results show paZopanib demonstrated non-inferiority to sunitinib in terms of progression free survival.

The trial was an open label, head-to-head study where all patients were treated for advanced renal cell carcinoma with a component of clear cell histology, and had received no prior systemic therapy for advanced or metastatic renal cell carcinoma.

Memorial Sloan-Kettering Cancer Center managing director and study lead investigator, Robert J. Motzer, announced the findings during the Presidential Symposium of the ESMO 2012 Congress of the European Society for Medical Oncology held in Vienna, Austria, on 1 October.

The study also found there was a statistically significant outcome in favour of paZopanib for 11 of the 14 domains, such as quality of life instruments, which included measurements of fatigue, mouth and throat soreness and foot soreness, among other measures.

“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,” GSK Oncology president and managing director Paolo Paoletti said.

For the study 1110 patients were randomised to receive treatment with either paZopanib or sunitinib at their respective, approved treatment doses.

The primary endpoint was non-inferiority in progression-free survival (PFS).

Secondary endpoints included overall survival, objective response rate, and duration of response, health-related quality of life, safety and medical resource utilisation.

Patients were treated in both arms until they showed either disease progression, unacceptable toxicity, voluntarily withdrew from study or died due to any cause.

Eleven patients had fatal adverse effects during the trial that were considered drug-related events by investigator assessments; three in the pazopanib arm and eight in the sunitinib arm.


Image: GlaxoSmithKline corporate headquarters in Brentford, UK. Photo: Courtesy of GSK Media Centre.

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