ponse rate was statistically significantly higher in AFINITOR-treated patients. There were 27 (35%) patients with SEGA responses in the AFINITOR arm and no SEGA responses in the placebo arm. Results are displayed in Table 16. At the time of the final analysis, all SEGA responses were ongoing and the median duration of response was 5.3 months (range 2.1 to 8.4 months). No patient in either treatment arm required surgical intervention during the course of Study 1.
Table 16: SEGA Response a Per independent central radiology review
AFINITOR Placebo p-value
N=78 N=39
Final analysis
SEGA response ratea - (%) 35 0 <0.0001
95% CI 24, 46 0, 9
With a median follow-up of 8.4 months, SEGA progression was detected in 6 of 39 (15.4%) patients randomized to receive placebo and none of the 78 patients randomized to receive AFINITOR.
Study 2 was an open-label, single-arm trial conducted to eva luate the safety and efficacy of AFINITOR in patients with SEGA and TSC. Serial radiological evidence of SEGA growth was required for entry. Change in SEGA volume at the end of the core 6-month treatment phase was assessed via independent central radiology review. In total, 28 patients received treatment with AFINITOR; median age was 11 years (range 3-34), 61% male, 86% Caucasian. Four patients had surgical resection of their SEGA lesions with subsequent re-growth prior to receiving AFINITOR treatment. After the core treatment phase, patients could continue to receive AFINITOR treatment as part of an extension treatment phase where SEGA volume was assessed every 6 months. The median duration of treatment was 34.2 months (range 4.7-47.1 months).
At 6 months, nine of 28 patients (32%, 95% CI: 16% to 52%) had a ≥ 50% reduction in the tumor volume of their largest SEGA lesion. The median duration of response for these nine patients was 11.8 months (range 3.2 to 39.1 months). Seven of these nine patients had an ongoing volumetric reduction of ≥ 50% at the data cutoff.
Three of four patients who had prior surgery experienced a ≥ 50% reduction in the tumor volume of their largest SEGA lesion. One of these three patients responded by month 6. No patient developed new lesions.
15 REFERENCES
1.Motzer RJ, Bacik J, Schwartz LH, et al. Prognostic factors for survival in previously treated patients with metastatic renal cell cancer. J Clin Oncol (2004) 22:454-63.
2.OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
16 HOW SUPPLIED/STORAGE AND HANDLING
AFINITOR (everolimus) Tablets
2.5 mg tablets
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other; available in:
Blisters of 28 tablets…………………………………………………………NDC 0078-0594-51
Each carton contains 4 blister cards of 7 tablets each
5 mg tablets
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other; available in:
Blisters of 28 tablets……………………&hel |
