Temsirolimus: Phase III data
Top-line data from the open-label, international Phase III INTORACT (B1771006) trial in 800 patients showed that first-line treatment with once-weekly 25 mg IV Torisel plus Avastin bevacizumab every 8 weeks missed the primary endpoint of PFS vs. Avastin plus interferon alfa-2a. Pfizer declined to provide detailed data or next steps, but did say that the study outcome does not change the safety and efficacy of single agent Torisel for advanced RCC.
Separately, in a pipeline update last week the pharma said it discontinued development of Torisel for RCC following disease progression on or after the pharma's Sutent sunitinib. In May, Pfizer reported top-line data from the Phase III INTORSECT trial in 512 patients with advanced RCC who failed first-line treatment with Sutent sunitinib showing that Torisel missed the primary endpoint of PFS vs. Nexavar sorafenib (see BioCentury, May 21). ...