Nexavar offers new treatment option in renal cell cancer

Bayer has launched Nexavar (sorafenib [as tosylate]) for the treatment of advanced renal cell carcinoma that has failed prior interferon alfa or interleukin-2 therapy or where such therapy is unsuitable.

Sorafenib is a multikinase inhibitor that has a direct antiproliferative effect along with anti-angiogenic activity and has been shown to inhibit the tumour growth of a number of human tumour xenografts.

The efficacy of sorafenib has been tested in two main multicentre placebo-controlled clinical trials. The first study involved 903 patients with clear cell carcinoma and low to intermediate risk MSKCC (Memorial Sloan Kettering Cancer Centre). The primary endpoints were overall survival and progression-free survival. Secondary endpoints included overall response rates (RECIST) and quality of life assessment.

For patients randomised to the sorafenib treatment group the median progression-free survival after 66 weeks was twice that of the placebo group (167 days versus 84 days). An interim analysis of overall survival was conducted at 367 deaths in 903 patients and the median survival was found to be 19.3 months for sorafenib compared with 15.9 months for those given placebo.

Best overall response rates, according to independent review, showed that overall 80% of patients achieved disease control, with 78% of patients in the treatment group having stable disease compared with 55% of the placebo group. Nine per cent of those given sorafenib had progressive disease compared with 30% of those given placebo. At the time of analysis, approximately 200 patients had crossed over to the sorafenib group from the placebo group. The full results including overall survival are expected later this year as the survival data mature.

In a phase II discontinuation study involving 220 patients with metastatic malignancy including renal cell carcinoma, progression-free survival was again significantly longer for those in the sorafenib treatment group (163 days) compared with the placebo control group (41 days).

Further information: Bayer Plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA. Tel: (01635) 563000.

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