n PFS was not yet reached in the SUTENT arm and was 34.3 weeks on the IFN-α arm (HR 0.371, 95% CI [0.214 – 0.643]); for the 421 patients (56%) with 1 or 2 risk factors, median PFS was 47.3 weeks on the SUTENT arm and 16.0 weeks on the IFN-α arm (HR 0.388, 95% CI [0.281 – 0.537]); and for the 48 patients (6%) with ≥3 risk factors, median PFS was 18.0 weeks on the SUTENT arm and 5.7 weeks on the IFN-α arm (HR 0.534 95% CI [0.231 – 1.234]).
Table 7. MRCC Efficacy Results CI=Confidence interval, NA=Not applicable
*
Assessed by blinded core radiology laboratory; 90 patients' scans had not been read at time of analysis
†
Assessed by investigators
‡
Median DR has not yet been reached
§
Data not mature enough to determine upper confidence limit
Treatment-Naive MRCC
Efficacy Parameter SUTENT
(n=375) IFN-α
(n=375) P-value (log-rank test) HR
(95% CI)
Progression-Free Survival*
[median, weeks (95% CI)] 47.3
(42.6, 50.7) 22.0
(16.4, 24.0) <0.000001 0.415
(0.320, 0.539)
Time to Tumor Progression*
[median, weeks (95% CI)] 47.9
(45.9, 50.7) 22.3
(17.3, 31.3) <0.0001 0.416
(0.318, 0.545)
Objective Response Rate*
[%, (95% CI)] 27.5
(23.0, 32.3) 5.3
(3.3, 8.1) <0.0001 NA
Efficacy Parameter Cytokine-Refractory MRCC
Study 1
(N = 106) Study 2
(N = 63)
Objective Response Rate
[%, (95% CI)] 34.0*
(25.0, 43.8) 36.5†
(24.7, 49.6)
Duration of Response
[median, weeks (95% CI)] ‡
(42.0, §) 54†
(34.3, 70.1)
Figure 2. Kaplan-Meier Curve of PFS in Treatment-Naïve MRCC Study (Intent-to-Treat Population)
The FKSI-DRS (Disease Related Symptom Scale of the Functional Assessment of Cancer Therapy - Advanced Kidney Cancer Symptom Index) was used to assess patient-reported kidney cancer related symptoms (lack of energy/fatigue, pain/bone pain, weight loss, shortness of breath, cough, fever, and hematuria) in 719 patients. Patients treated with SUTENT reported statistically significant (p<0.0001) better FKSI-DRS index scores than patients treated with IFN-α in all post-baseline assessment time points up to nine cycles of treatment.
Cytokine-Refractory MRCC
The use of single agent SUTENT in the treatment of cytokine-refractory MRCC was investigated in two single-arm, multi-center studies. All patients enrolled into these studies experienced failure of prior cytokine-based therapy. In Study 1, failure of prior cytokine therapy was based on radiographic evidence of disease progression defined by RECIST or World Health Organization (WHO) criteria during or within 9 months of completion of 1 cytokine therapy treatment (IFN-α, interleukin-2, or IFN-α plus interleukin-2; patients who were treated with IFN-α alone must have received treatment for at least 28 days). In Study 2, failure of prior cytokine therapy was defined as disease progression or unacceptable treatment-related toxicity. The primary endpoint for both studies was ORR. DR was also eva luated.
One hundred six patients were enrolled into Study 1, and 63 patients were enrolled into Study 2. Patients received 50 mg SUTENT on Schedule 4/2. Therapy was continued until the patients met withdrawal criter
