Pfizer fails to meet primary endpoint in TORISEL Phase 3 study for advanced RCC

Pfizer Inc. announced that the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL^® (temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after SUTENT^® (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib. Although PFS 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. Adverse events in this study were consistent with the known safety profiles for both drugs. Full efficacy and safety data from this study will be presented at an upcoming major medical congress.    

Approximately 270,000 people worldwide are diagnosed with renal cell cancer every year with about 20 percent having advanced disease at the time of diagnosis. Between 40 and 65 percent of patients in the U.S. who progress following first-line therapy go on to receive a second-line treatment.

"This trial advances our knowledge about TORISEL in RCC. TORISEL remains an important drug for treatment of advanced kidney cancer based on its pivotal study in first-line patients with poor prognostic risk," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit. "TORISEL continues to be an important part of Pfizer's portfolio of therapies for advanced kidney cancer."