SUTENT Efficacy in first-line metastatic RCC

In the treatment of advanced renal cell carcinoma (RCC): SUTENT demonstrated significant efficacy over interferon alfa (IFNα) as a first-line therapy for metastatic RCC (mRCC)

Phase III, randomized, multicenter trial comparing SUTENT with IFNα as first-line therapy in mRCC

• Patients with mRCC (N=750) were randomized into one of two treatment arms:

           - SUTENT 50 mg (oral) QD, 4 weeks on/2 weeks off
           - IFNα 9 MIU 3 per week

• Primary endpoint: progression-free survival (PFS)
• Secondary endpoints: objective response rate (ORR), overall survival (OS), patient-reported outcomes, safety

View Methodology Diagram For Phase III SUTENT mRCC study

Phase III, randomized, multicenter trial comparing SUTENT with IFNα as first-line therapy in mRCC

SUTENT more than doubled median PFS vs IFNα (11 months vs 5 months)

Median PFS was reached at the first interim analysis.



Results of an interim analysis from a phase III, randomized, multicenter, international trial. Patients were treated with either 50-mg SUTENT once daily in cycles of 4 weeks on/2 weeks off or 9 MIU IFNα 3 times per week (administered subcutaneously) until disease progression or study withdrawal. Primary endpoint was PFS, and secondary endpoints included objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST), OS, patient-reported outcomes, and safety.

• 58% reduced risk of progression or death

PFS results favored SUTENT across patient baseline factors

Prespecified subgroups included lactate dehydrogenase (LDH), ECOG performance status, and prior nephrectomy.



Results of a Cox proportional hazard model to explore the potential influences of the baseline stratification factors (LDH, ECOG performance status, prior nephrectomy) on PFS. In addition, the potential influences of baseline patient characteristics such as age, gender, ethnic origin, time since first diagnosis, hemoglobin, corrected calcium, alkaline phosphatase, and albumin were evaluated.

SUTENT achieved a median OS of more than 2 years¹



Median OS was event driven and met at the third analysis (February 2008).

• The median OS for patients receiving SUTENT was 26.4 months vs 21.8 months with IFNα

           - Unstratified analysis: HR=0.821; 95% CI: 0.673, 1.001; P=.051
           - Stratified analysis*: HR=0.818; 95% CI: 0.669, 0.999; P=.049

• 6% of the patients in the IFNα arm crossed over to SUTENT during the study; poststudy, 33% of the patients in the IFNα arm received SUTENT
• Patient accrual occurred from August 2004 through October 2005

           - At the time of the third analysis (February 2008), 52 patients
             (14%) remained on assigned treatment with SUTENT vs
             6 patients (2%) with IFNα

*Stratification factors: ECOG performance status score, LDH, prior nephrectomy.

5-fold higher objective response rate with SUTENT vs IFNα



Response as defined by RECIST and assessed by blinded core radiology laboratory; 90 patients' scans had not been read at the time of the first analysis. No patients achieved a complete response (CR) in either study arm. ORR = CR + partial response (PR).

Response rates in both analyses



RECIST criteria define PR as a >30% decrease (from baseline) in the sum of the longest diameter of target lesions; SD as insufficient tumor shrinkage for PR but <20% increase for PD in the smallest sum of the longest diameter of target lesions from baseline since the treatment started; PD as a >20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter of target lesions recorded since the treatment started, or the appearance of one or more new lesions. Data were not available for some patients in the SUTENT and IFNα arms (16% and 26% [first interim analysis]; 5% and 7% [second interim analysis], respectively).

View the safety and tolerability information related to this study.