Pfizer announced Friday that a Phase III study of Sutent (sunitinib) met its primary endpoint of improving disease-free survival (DFS) versus placebo in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery. The company noted that the S-TRAC trial is the first RCC study of a tyrosine kinase inhibitor to prolong DFS in the adjuvant setting.
Mace Rothenberg, Pfizer's chief medical officer of oncology, stated, "we believe the results...support the potential for Sutent to be a treatment option in a broader range of patients," adding "we look forward to...discussing these data with health authorities to determine an appropriate regulatory path forward."
In the study, more than 670 patients at high risk of recurrent RCC were randomised to treatment with Sutent or placebo for one year, with subjects divided into global and Chinese cohorts. Pfizer noted that the current top-line analysis only includes data for the global cohort. The drugmaker added that results from the Chinese cohort are not yet mature and will be presented at a future date. Meanwhile, full safety and efficacy data from the S-TRAC trial will be presented at the European Society for Medical Oncology congress in October.
Sutent gained US approval in 2006 for the treatment of advanced RCC and gastrointestinal stromal tumours, while the therapy was also awarded conditional EU marketing clearance for the two indications in the same year. Sutent is also approved in several markets, including the US and EU, for the treatment of patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours.
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