Efficacy

OS

|

PFS

|

ORR
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

  • 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.2
 
*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
 

Median duration of treatment

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 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).
 

 

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).
 
 

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.3.2015. © National Comprehensive Cancer Network, Inc 2014. All rights reserved. Accessed January 13, 2015. To view the most recent and complete version of the guideline, go online to www.nccn.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.