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Pfizer's Torisel misses primary endpoint of Phase III trial in advanced RCC

Wednesday, May 16 2012 | Comments
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Pfizer Inc.'s Torisel (temsirolimus) did not meet the primary endpoint of the Phase III INTORSECT trial, which was evaluating the drug as a second-line treatment for advanced renal cell carcinoma (RCC). The trial had an estimated enrollment of more than 500 patients with advanced RCC whose disease had progressed on or after treatment with Pfizer's Sutent (sunitinib malate). The primary endpoint compared progression-free survival (PFS) achieved with Torisel versus PFS achieved with...

Pfizer Inc.'s Torisel (temsirolimus) did not meet the primary endpoint of the Phase III INTORSECT trial, which was evaluating the drug as a second-line treatment for advanced renal cell carcinoma (RCC).

The trial had an estimated enrollment of more than 500 patients with advanced RCC whose disease had progressed on or after treatment with Pfizer's Sutent (sunitinib malate).

The primary endpoint compared progression-free survival (PFS) achieved with Torisel versus PFS achieved with Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals Inc.'s Nexavar (sorafenib tosylate).

PFS was numerically higher with Torisel, but the difference between Torisel and Nexavar was not statistically significant.

Overall survival, a secondary endpoint, was significantly longer with Nexavar than with Torisel.

Adverse events were consistent with the known safety profiles for both drugs.

Pfizer noted that full efficacy and safety data for this trial will be presented at an upcoming medical congress.

Torisel is approved for the treatment for advanced RCC.

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