eatment period. The primary objective was to compare Progression-Free Survival (PFS) in patients receiving SUTENT versus patients receiving placebo. Other endpoints included Overall Survival (OS), Objective Response Rate (ORR), and safety. Use of somatostatin analogs was allowed in the study.
Demographics were comparable between the SUTENT and placebo groups. Additionally, 49% of SUTENT patients had non-functioning tumors vs 52% of placebo patients, and 92% patients in both arms had liver metastases. A total of 66% of SUTENT patients received prior systemic therapy compared with 72% of placebo patients and 35% of SUTENT patients had received somatostatin analogs compared with 38% of placebo patients. Patients were treated until disease progression or withdrawal from the study. Upon disease progression, or study closure, patients were offered access to SUTENT in a separate extension study.
As recommended by the Independent Data Monitoring Committee, the study was terminated prematurely prior to the pre-specified interim analysis. This may have led to an overestimate of the magnitude of PFS effect. A clinically significant improvement for SUTENT over placebo in PFS was seen by both investigator and independent assessment. A hazard ratio favoring SUTENT was observed in all subgroups of baseline characteristics eva luated. OS data were not mature at the time of the analysis. There were 9 deaths in the SUTENT arm and 21 deaths in the placebo arm. A statistically significant difference in ORR favoring SUTENT 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 Efficacy Parameter SUTENT
(n=86) Placebo
(n=85) P-value HR
(95% CI)
CI=Confidence interval, HR=Hazard ratio, NA=Not applicable
2-sided unstratified log-rank test
Fisher's Exact test
Progression-Free Survival [median, months (95% CI)] 10.2
(7.4, 16.9) 5.4
(3.4, 6.0) 0.000146* 0.427
(0.271, 0.673)
Objective Response Rate [%, (95% CI)] 9.3
(3.2, 15.4) 0 0.0066† NA
CI=Confidence interval, HR=Hazard ratio, NA=Not applicable
2-sided unstratified log-rank test
Fisher's Exact test
Progression-Free Survival [median, months (95% CI)] 10.2
(7.4, 16.9) 5.4
(3.4, 6.0) 0.000146* 0.427
(0.271, 0.673)
Objective Response Rate [%, (95% CI)] 9.3
(3.2, 1.4) 0 0.0066† NA
Figure 3. Kaplan-Meier Curve of PFS in the pNET Phase 3 Study
16HOW 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].
17PATIENT COUNSELING INFORMATION
See 17.5 for FDA-Approved Patient Labeling.
17.1Gastrointestinal Disorders
Gastrointestinal disorders |
