AFINITOR is a once-daily oral inhibitor of mTOR (mammalian target of rapamycin) for patients with advanced renal cell carcinoma (RCC) whose disease has progressed on or after treatment with VEGF-targeted therapy
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Efficacy
The proven therapy in advanced renal cell carcinoma after VEGF** failure.
AFINITOR® (everolimus) tablets more than doubled median progression-free survival (PFS) after initial VEGF-targeted therapy
- AFINITOR more than doubled median PFS from 1.87 to 4.90 months1
- Patients had a 36% probability of being progression free at 6 months based on Kaplan-Meier estimates1,2
- 67% reduction in relative risk of progression or death as compared with placebo, across all MSKCC* risk groups (P<0.0001)1 based on the primary endpoint of progression-free survival
AFINITOR demonstrated a clinical benefit† rate of 69%3
- In the majority of patients taking AFINITOR, target lesions were reduced in size, but not sufficiently to qualify as a partial response under Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Review the clinical trial design. This section includes an overview of the rigorous design of the pivotal Phase III clinical trial that included all MSKCC* risk groups, with 74% of patients previously treated with only one VEGF TKI.
Next: Safety and Tolerability
*MSKCC: Memorial Sloan-Kettering Cancer Center
**VEGF: vascular endothelial growth factor
†Clinical benefit (no progressive disease) refers to stable disease‡ + partial response (SD + PR), according to RECIST criteria.4
‡Stable disease was defined as disease that remained unchanged for at least 56 days (neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease). Tumor response was evaluated by independent radiological review according to RECIST criteria. Efficacy evaluations were performed every 8 weeks and included CT scans, MRI and bone scans.5
References:
1. AFINITOR [summary of product information]. Basel Switzerland: Novartis Pharma AG.
2. Kay A, Motzer R,Figlin R, et al. Updated data from a Phase 3 randomized trial of everolimus (RAD001) vs PBO in metastatic renal cell carcinoma (mRCC). 2009 Genitourinary Cancers Symposium. February 26-28, 2009. Orlando, FL. http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=64&abstractID=20488. Accessed April 8,2009.
3. Data on file. Novartis Pharma AG. Basel, Switzerland.
4. Therasee P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92:205-216.
5. Motzer RJ, Escudier B. Oudard S, et al; for the RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomized, placebo-controlled phase III trial. Lancet. 2008; 372:449-456.
