Published on August 12, 2012 at 2:37 AM
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. 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.
Source: Pfizer Inc.