Pfizer Inc. announced today that the Phase 3 INTORACT trial (B1771006), evaluating the combination of bevacizumab plus TORISEL® (temsirolimus) 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.
“This trial advances our knowledge about the role and limitations of combining targeted therapies in the treatment of advanced RCC,” said Dr. 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.”
Approximately 270,000 new cases of this tumor are diagnosed worldwide annually, and about 20 percent of cases present with advanced disease at the time of diagnosis. 1 Approximately 13,000 individuals die of this tumor in the U.S. each year.
The combination of bevacizumab and IFN-α-2a is approved as first-line treatment for advanced RCC and clinical supplies of both of these drugs in this trial were provided through an agreement with Roche.About TORISEL® (temsirolimus) TORISEL is approved in the U.S. and other countries for the treatment of advanced RCC. TORISEL is approved in the European Union for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. TORISEL is the only intravenous mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of advanced RCC. TORISEL is the only treatment to show a significant improvement in overall survival (OS) in treatment-naïve, poor risk patients with advanced RCC in a Phase 3 pivotal trial.
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