6 YEARS - PfizerPro

over placebo was observed. Efficacy results are summarized in Table 10 and the Kaplan-Meier curve for PFS is
in Figure 3.
Table 10. pNET Efficacy Results from the Phase 3 Study
SUTENT Placebo P-value
HR
Efficacy Parameter
(n=86) (n=85)
(95% CI)
Progression-Free Survival [median,
months (95% CI)]
10.2
(7.4, 16.9)
5.4
(3.4, 6.0)
0.000146 a 0.427
(0.271, 0.673)
Objective Response Rate
9.3
0 0.0066 b NA
[%, (95% CI)]
(3.2, 15.4)
CI=Confidence interval, HR=Hazard ratio, NA=Not applicable
a 2-sided unstratified log-rank test
b Fisher’s Exact test
Figure 3. Kaplan-Meier Curve of PFS in the pNET Phase 3 Study
Progression Free Survival Probability (%)
100
90
80
70
60
50
40
30
20
10
0
Hazard Ratio = 0.427
95% CI (0.271 - 0.673)
p = 0.000146
SUTENT (N=86)
Median 10.2 months
Placebo (N=85)
Median 5.4 months
0 3 6 9 12 15 18 21
Number of subjects at risk
Time (Months)
SUTENT 86 53 35 19 14 4 1
Placebo 85 41 16 8 2 2 2
16 HOW SUPPLIED/STORAGE AND HANDLING
12.5 mg Capsules
Hard gelatin capsule with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN
12.5 mg” on the body; available in:
Bottles of 28: NDC 0069-0550-38
25 mg Capsules
Hard gelatin capsule with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25
mg” on the body; available in:
Bottles of 28: NDC 0069-0770-38
50 mg Capsules
Hard gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN
50 mg” on the body; available in:
Bottles of 28: NDC 0069-0980-38
Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
See 17.6 for FDA-Approved Patient Labeling.