Efficacy

Powerful 1st-line evidence in poor-risk patients with advanced RCC
 

In the phase 3 Global ARCC study of TORISEL vs IFNa…

TORISEL significantly extended overall survival (OS) in poor-risk patients (primary endpoint)

  • 94% of patients in the pivotal phase 3 trial (N=626) were poor risk based on having ≥3 of 6 preselected risk factors1*
Results from a phase 3, multicenter, randomized, open-label study in previously untreated patients with advanced RCC who had 3 of 6 preselected prognostic risk factors. Patients received TORISEL (n=209, 25 mg IV once weekly) or IFNa (n=207, maximum 18 MU SubC 3 times weekly). In a third arm of the trial, treatment with the combination of TORISEL 15 mg and IFNa (n=210) was associated with an increase of multiple adverse reactions and did not result in a significant increase in OS compared with IFNa alone.1
 
*Preselected prognostic risk factors included: <1 year from the initial diagnosis to randomization, Karnofsky performance status (KPS) of 60 or 70, corrected serum calcium >10 mg/dl, lactate dehydrogenase (LOH) >1.5 x upper limit of normal, hemoglobin <lower limit of normal (LLN), and 2 sites of metastasis.1
Based on Cox proportional hazard model stratified by prior nephrectomy and region.
A comparison is considered statistically significant if the P value is <.0159 (O’Brien-Fleming boundary at 446 deaths).
§Based on log-rank test stratified by prior nephrectomy and region.
 

Median duration of treatment1

17 weeks (range, 1-126 weeks) for TORISEL vs 8 weeks (range, 1-124 weeks) for IFNa

 

In the phase 3 Global ARCC study of TORISEL vs IFNa…

TORISEL significantly extended progression-free survival (PFS) (secondary endpoint)

 
Results from a phase 3, multicenter, randomized, open-label study in previously untreated patients with advanced RCC who had 3 of 6 preselected prognostic risk factors. Patients received TORISEL (n=209, 25 mg IV once weekly) or IFNa (n=207, maximum 18 MU SubC 3 times weekly).1
*Based on Cox proportional hazard model stratified by prior nephrectomy and region.
Based on log-rank test stratified by prior nephrectomy and region.
Not adjusted for multiple comparisons.
 
 

 

In the phase 3 Global ARCC study of TORISEL vs IFNa…

Overall response rate (secondary endpoint)

  • 8.6% (95% Cl: 4.8, 12.4) for patients receiving TORISEL vs 4.8% (95% Cl: 1.9, 7.8) for IFNa; results were not statistically significant (P=.1232)*†‡

  • All responses were partial responses per RECIST criteria, based on blinded independent radiologic assessment of tumor response1,2
Results from a phase 3, multicenter, randomized, open-label study in previously untreated patients with advanced RCC who had 3 of 6 preselected prognostic risk factors. Patients received TORISEL (n=209, 25 mg IV once weekly) or IFNa (n=207, maximum 18 MU SubC 3 times weekly).1
*Based on log-rank test stratified by prior nephrectomy and region.
Not adjusted for multiple comparisons.
Based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and region.
 

REFERENCES
  1. Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356(22):2271-2281.
  2. Data on file. Pfizer Inc, New York, NY.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.2.2019. © National Comprehensive Cancer Network, Inc 2018. All rights reserved. Accessed September 17, 2018. To view the most recent and complete version of the guideline, go online to www.nccn.org.