Pfizer Inc (PFE) announced that the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL (temsirolimus) in patients with advanced renal cell carcinoma or RCC whose disease had progressed on or after SUTENT (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival or PFS when compared to sorafenib.
Although PFS was numerically higher in patients treated with temsirolimus, the difference was not statistically significant, the company said.
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.
TORISEL is approved in the US and other countries for the treatment of advanced RCC. TORISEL is approved in the European Union for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors.
In a pivotal Phase 3 study, TORISEL demonstrated median overall survival (OS) 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).
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