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TORISEL Clinical Trial Design and Results1

TORISEL was studied in a phase 3, multicenter, 3-arm, randomized, open-label study conducted in 626 previously untreated patients with advanced renal cell carcinoma (RCC) with at least 3 of 6 prognostic risk factors.

This study was called the Global Advanced Renal Cell Carcinoma (ARCC) Study. Objectives were to compare the following parameters in patients receiving interferon-alpha (IFN-α) vs. patients receiving TORISEL or TORISEL plus
IFN-α:

  • Primary end point: overall survival (OS)
  • Secondary end points included progression-free survival (PFS) and objective response rate (ORR)
  • Safety profile

Trial Design

TORISEL clinical trial design patient randomization

Treatment with the combination of TORISEL 15 mg and IFN-α was associated with an increased incidence of multiple adverse reactions and did not result in a significant increase in overall survival (OS) when compared with
IFN-α alone.1-3

For this reason, the following results do not include those associated with the combination arm in the Global ARCC Study.

Disease Characteristics

Patient age, gender, and race were comparable across all three treatment arms.1

Trial Results

  • TORISEL demonstrated a statistically significant 49% increase in median overall survival (OS) compared with interferon-alpha (IFN-α) (P=0.0078*)1
  • The O'Brien-Fleming boundary for early success (P<0.0159) was reached at the second planned interim analysis1,2

Primary End Point: Median Overall Survival Chart

CI=confidence interval

The median duration of treatment in the TORISEL arm was 17 weeks (range 1-126 weeks). The median duration of treatment on the IFN-α arm was 8 weeks (range 1-124 weeks).1

* A comparison is considered statistically significant if the P-value is <0.0159 (O’Brien-Fleming
   boundary at 446 deaths).
† Based on log-rank test stratified by prior nephrectomy and region.
‡ Based on Cox proportional hazard model stratified by prior nephrectomy and region.
§ Time from randomization to death.

Secondary End Points

* Response was assessed with the use of RECIST.
† Based on log-rank test stratified by prior nephrectomy and region.
‡ Based on Cox proportional hazard model stratified by prior nephrectomy and region.
§ Progression-free survival; time from randomization to disease progression or death censored
    at the last tumor evaluation date.
ll Time to treatment failure.
¶ CR plus PR. Independent assessment.
# Based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and region.
** Complete response, partial response, or stable disease for ≥ 24 weeks. Independent assessment.

Clinical trials

Please click here for Important Safety Information
Next: TORISEL Mechanism of Action »

TORISEL as 1st- and 2nd-Line
Treatment Option

NCCN recommends TORISEL as a first-
and second-line treatment option in
advanced RCC.4

Contact Wyeth About TORISEL

 

References:

  1. TORISEL® Kit (temsirolimus) Prescribing Information, Wyeth Pharmaceuticals Inc.
  2. Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma.
    N Engl J Med. 2007;356:2271-2281.
  3. Data on file, Wyeth Pharmaceuticals Inc.
  4. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: kidney cancer. V.1.2009.

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