advanced kidney cancer who have experienced treatment failure with the most
commonly used first-line therapies," said Robert J. Motzer, MD, attending
physician, Memorial Sloan-Kettering Cancer Center, New York, and principal
investigator of the RECORD-1 trial. "The results show RAD001 extended
progression-free survival in patients regardless of their prior treatments,
risk status, age, or gender."
During the second half of 2008, the interim results from RECORD-1 will
be used to submit a new drug application for RAD001 as a treatment for
metastatic renal cell carcinoma.
"As we will see in presentations at the upcoming meeting, RAD001 has
the potential to benefit patients living with a variety of cancers
including neuroendocrine, breast, gastric, and lung," said David Epstein,
CEO and President of Novartis Oncology. "We look forward to updates from
trials in pancreatic neuroendocrine tumors before year-end."
RECORD-1 is the largest Phase III clinical trial investigating the
effects of an oral mTOR inhibitor in metastatic RCC. It is a randomized,
double-blind placebo-controlled multicenter trial of more than 400 patients
with RCC whose cancer worsened despite prior treatment, including Nexavar
or Sutent, or both. In addition, prior therapy with Avastin, interferon,
and interleukin-2 was allowed.
The primary endpoint of RECORD-1 was progression-free survival (PFS)
assessed via a blinded, independent central review and defined as the
amount of time between randomization and first documented disease
progression or death due to any cause. Results of the study demonstrated a
statistically significant improvement in PFS for RAD001 compared to placebo
(hazard ratio = 0.30 with 95% CI 0.22 to 0.40; p-value < 0.0001; median PFS
4 months vs. 1.9 months, respectively).
Secondary endpoints included comparison of overall survival, objective
response rate, quality of life, safety, and pharmacokinetics. There was no
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