In this study the objective response rate was 36.5% (95% C.I. 24.7% - 49.6%) and the median time to progression (TTP) was 37.7 weeks (95% C.I. 24.0 - 46.4 weeks).

A confirmatory, open-label, single-arm, multi-centre study eva luating the efficacy and safety of sunitinib was conducted in patients with MRCC who were refractory to prior cytokine therapy. One hundred and six patients received at least one 50 mg dose of sunitinib on schedule 4/2.

The primary efficacy endpoint of this study was Objective Response Rate (ORR). Secondary endpoints included TTP, duration of response (DR) and overall survival (OS).

In this study the ORR was 35.8% (95% C.I. 26.8% – 47.5 %) The median DR and OS had not yet been reached.
Pancreatic neuroendocrine tumours (pNET)

A supportive phase 2, open-label, multi-center study eva luated the efficacy and safety of single-agent SUTENT 50 mg daily on Schedule 4/2 [4 weeks on treatment, 2-week rest period] in patients with unresectable pNET. In a pancreatic islet cell tumour cohort of 66 patients, the primary endpoint of response rate was 17%.

A pivotal phase 3, multi-centre, international, randomized, double-blind placebo-controlled study of single-agent sunitinib was conducted in patients with unresectable pNET.
Patients were required to have documented progression, based on RECIST,, within the prior 12 months and were randomized (1:1) to receive either 37.5 mg sunitinib once daily without a scheduled rest period (n=86) or placebo (n=85).
The primary objective was to compare Progression-Free Survival (PFS) in patients receiving sunitinib versus patients receiving placebo. Other endpoints included Overall Survival (OS), Objective Response Rate (ORR), Patient-reported Outcomes (PRO) and safety.
Demographics were comparable between the sunitinib and placebo groups. Additionally, 49% of sunitinib patients had non-functioning tumours versus 52% of placebo patients and 92% patients in both arms had liver metastases.
Use of somatostatin analogs was allowed in the study.
A total of 66% of sunitinib patients received prior systemic therapy compared with 72% of placebo patients. In addition, 24% of sunitinib patients had received somatostatin analogs compared with 22% of placebo patients.
A clinically significant advantage in investigator-assessed PFS for sunitinib over placebo was observed. The median PFS was 11.4 months for the sunitinib arm compared to 5.5 months for the placebo arm [hazard ratio: 0.418 (95% CI 0.263, 0.662), p-value =0.0001]; similar results were observed when derived tumour response assessments based upon application of RECIST to investigator tumour measurements were used to determine disease progression, as shown in Table 6. A hazard ratio favouring SUTENT was observed in all subgroups of baseline characteristics eva luated, including an analysis by number of prior systemic therapies. A total of 29 patients in the sunitinib arm and 24 in the placebo arm had received no prior systemic treatment; among these patients, the hazard ratio for PFS was 0.365 (95% CI 0.156, 0.857), p=0.0156. Similarly, among 57 patients in the sunitinib arm (including 28 with 1 prior s