Phase III study of Torisel (Pfizer) for Renal Cell Carcinoma does not meet primary endpoint

The Phase III INTORSECT (B1771003) study, evaluating Torisel (temsirolimus), from Pfizer, in patients with advanced Renal Cell Carcinoma whose disease had progressed after sunitinib malate therapy, did not meet the primary endpoint of prolonging progression free survival when compared to sorafenib. Although survival was numerically higher in patients treated with temsirolimus, the difference was not statistically significant. Overall survival, a secondary endpoint in the study, showed statistical significance favoring patients randomized to the sorafenib arm. In another pivotal Phase III study, Torisel demonstrated median overall survival in previously untreated patients of 10.9 months in patients with advanced RCC with poor prognostic risk, compared with 7.3 months for interferon-alpha (IFN-a). Full efficacy and safety data from this study will be presented at an upcoming major medical congress.