Pfizer has reported topline results from Phase III INTORSECT (B1771003) study of Torisel as second-line treatment in advanced renal cell carcinoma (RCC).
In the study, Torisel in RCC patients, whose disease had progressed on or after SUTENT therapy, did not meet the primary endpoint of prolonging progression free survival when compared to sorafenib.
Overall survival, a secondary endpoint in the study, showed statistical significance favoring patients randomized to the sorafenib arm.
The study reported consistent adverse events with the known safety profiles for both drugs, the company said.
Pfizer Oncology Business Unit clinical development and medical affairs senior vice president Mace Rothenberg said TORISEL remains an important drug for treatment of advanced kidney cancer based on its pivotal study in first-line patients with poor prognostic risk.
Torisel is the intravenous mammalian target of rapamycin inhibitor approved for the treatment of advanced RCC.