Pfizer's Torisel plus Avastin misses in first-line RCC

Pfizer Inc. (NYSE:PFE) said first-line treatment with IV Torisel temsirolimus plus Avastin bevacizumab missed the primary endpoint of improving progression-free survival (PFS) vs. Avastin plus interferon alfa-2a in the Phase III INTORACT trial in 800 advanced renal cell carcinoma patients. Pfizer declined to provide details or next steps, but did say the study outcome does not change the safety and efficacy of single agent Torisel for advanced RCC. Pfizer markets Torisel in the U.S. to treat advanced RCC; the label does not specify a line of treatment. In the EU, Torisel is marketed for first-line treatment of advanced RCC and to treat mantle cell lymphoma (MCL).

In a pipeline update Friday, Pfizer discontinued development of Torisel following RCC disease progression on or after its Sutent sunitinib. In May, Torisel missed the primary endpoint of PFS in the Phase III INTORSECT trial in advanced RCC patients who failed first-line Sutent. In total, Pfizer discontinued eight projects since its last update in May, including Monday's termination of Phase III Alzheimer's disease (AD) candidate IV bapineuzumab. Pfizer has 87 programs in Phase I testing through registration, matching the number in development in its last update (see BioCentury Extra, May 15). ...