Pfizer says Torisel combo fails in Ph III for kidney cancer

In a second research disappointment within a matter of days, US drugs behemoth Pfizer (NYSE: PFE) revealed on Friday that the Phase III INTORACT trial (B1771006) evaluating its Torisel (temsirolimus) in combination with Roche’s Avastin (bevacizumab) compared with bevacizumab plus interferon-alfa-2a (IFN-α-2a) in the first-line treatment of patients with advanced renal cell carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population.

Additional efficacy endpoints and safety data for the combination treatments in both arms are being analyzed and will be presented at an upcoming major medical congress, the company said. Torisel is already approved for advanced RCC in markets including the USA and European Union.

“This trial advances our knowledge about the role and limitations of combining targeted therapies in the treatment of advanced RCC,” said Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit. “Additional analyses will be performed to help us understand this result. The study outcome, involving combination therapy, does not change the safety and efficacy relationship of single-agent Torisel for advanced RCC patients with a poor prognostic risk profile.”