Pfizer's Torisel fails in Ph III advanced renal cell cancer study

There was disappointment for global pharma behemoth Pfizer (NYSE: PFE) when it said that the Phase III INTORSECT (B1771003) study, evaluating Torisel (temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after therapy with Sutent (sunitinib malate, also a Pfizer drug), did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib (Bayer’s Nexavar).

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% having advanced disease at the time of diagnosis. Between 40% and 65% of patients in the USA who progress following first-line therapy go on to receive a second-line treatment.2