Temsirolimus + Bevacizumab Misses PFS Primary End Point in RCC

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(ChemotherapyAdvisor) – The combination of bevacizumab (Avastin, Genentech, South San Francisco, CA) and temsirolimus (Torisel, Pfizer Inc, New York, NY) did not meet its primary end point of progression-free survival when compared with bevacizumab plus interferon-alfa-2a in treatment-naïve patients with advanced renal cell carcinoma (RCC), Pfizer announced on August 10.

The phase 3b open-label INTORACT trial randomized a planned enrollment of 790 patients to bevacizumab 10mg/kg intravenous (IV) every 8 weeks plus the mammalian target of rapamycin (mTOR) inhibitor temsirolimus 25mg IV weekly or to bevacizumab 10mg/kg IV every 8 weeks plus interferon-alfa 9MU subcutaneously 3 times weekly. Study start date was April 2008.

“Additional efficacy end points and safety data for the combination treatments in both arms are being analyzed and will be presented at an upcoming major medical congress,” Pfizer stated in a press release.

Temsirolimus is approved in the United States and other countries for the treatment of advanced RCC and in the European Union for the first-line treatment of patients with advanced RCC who have at least 3 of 6 prognostic risk factors.

Press release

Clinicaltrials.gov listing

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