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GSK'S Pazopanib Shows Positive Results in Patients with Advanced,Renal Cell Carcinoma, Ovarian Cancer and Soft Tissue Sarcoma

CHICAGO, June 04, 2007 /PRNewswire/ -- GlaxoSmithKline today announced results from ongoing Phase II studies of pazopanib in advanced or metastatic renal cell carcinoma (RCC), ovarian cancer and soft tissue sarcoma (STS). These trials were presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. The results observed in these trials with pazopanib support further investigations.

Pazopanib is an oral, investigational angiogenesis inhibitor targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and c-kit, important proteins in the angiogenic process. Angiogenesis, which is the growth of new blood vessels in the body, plays a critical role in the growth and spread of tumors. (1,2)

Renal cell carcinoma study (Abstract 5031) (3)

This ongoing Phase II randomized discontinuation study is evaluating patients with advanced or metastatic RCC who have not received prior systemic therapy or have failed one prior therapy (cytokine or bevacizumab-containing regimen). All patients received 800 mg of pazopanib taken orally, once-daily during a 12 week lead-in period. Based on data available on 60 patients at the time of a planned interim analysis, the Independent Data Monitoring Committee (IDMC) recommended that randomization to placebo for patients with stable disease should be discontinued. The study continued as an open-label, single- arm study with all patients receiving pazopanib.

The preliminary week 12 response rate for all 225 patients was 27%. In addition, stable disease was achieved in 46% of patients for a total disease control rate of 73%. Responses have been observed beyond week 12, and the overall response rate will be reported at study completion. Response was determined according to RECIST (Response Evaluation Criteria In Solid Tumors) which is a set of published rules that defines when
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