S-TRAC Phase III data on Sutent (sunitinib) as adjuvant therapy in renal cell carcinoma shows extension in disease-free survival- Pfizer

Pfizer has announced results from the Phase III S-TRAC clinical trial (Sunitinib Trial as Adjuvant Treatment of Renal Cancer) investigating Sutent (sunitinib) as adjuvant therapy in Renal Cell Carcinoma. The trial showed Sutent extended disease-free survival (DFS) by more than one year versus placebo in patients who were at high risk for recurrence after surgical resection of renal cell carcinoma (RCC). The results from the S-TRAC trial showed that after one year of treatment, the median time until disease recurrence in participants treated with Sutent after surgery was 6.8 years compared with 5.6 years for patients treated with placebo as assessed by independent central review, resulting in an overall risk reduction of 24 percent. At the time of the analysis, overall survival (OS) data was immature. The adverse events seen in the trial were consistent with Sutent’s known safety profile. The most common adverse reactions (more than 20%) are fatigue, asthenia, and fever. These results will be presented at the ESMO 2016 Congress, in Copenhagen, Denmark. The results have also been published online by The New England Journal of Medicine.