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Axitinib (Inlyta) Fails to Meet Phase III Endpoint Versus Sorafenib in Renal Cancer

Progression-free survival not significantly different between the two drugs (Oct. 17)

A phase III study of axitinib (Inlyta, Pfizer) has failed to meet its primary endpoint of demonstrating significantly longer progression-free survival (PFS) versus sorafenib (Nexavar, Bayer) in treatment-naïve patients with advanced renal cell carcinoma (RCC).

AGILE 1051, a study involving more than 280 treatment-naïve patients with advanced RCC, was powered to show a 78% improvement in PFS benefit with axitinib over sorafenib. The primary endpoint of the study was PFS.

A preliminary review of the data showed that the median PFS for axitinib exceeded the median PFS for sorafenib but did not meet statistical significance. In a prespecified subgroup of patients classified as having a good performance status (Eastern Cooperative Oncology Group [ECOG] PS 0), the median PFS for axitinib exceeded the median PFS for sorafenib. In another prespecified subgroup of patients classified as having an intermediate performance status (ECOG PS 1), there was no difference between axitinib and sorafenib.

Earlier this year, Inlyta (axitinib) was approved in the U.S. for patients with previously treated advanced RCC. In the registrational phase III AXIS trial, axitinib significantly extended PFS, with a median PFS of 6.7 months compared with 4.7 months for patients treated with sorafenib.

Axitinib is indicated for the treatment of advanced RCC after the failure of one prior systemic treatment. The drug is designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2, and 3; these receptors can influence tumor growth, vascular angiogenesis, and the progression of cancer.

Source: Pfizer, October 17, 2012.

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