Proven Efficacy and Safety in the Largest Phase 3 Study for Advanced Renal Cell Carcinoma (RCC)¹

Largest Phase 3, multi-center, randomized, double blind, placebo-controlled trial:

• Compared the efficacy and safety of Nexavar vs placebo in patients with advanced RCC who had received one prior systemic therapy
• Primary study end points included overall survival and progression-free survival (PFS).
• Secondary endpoint was tumor response rate.
• Best overall tumor rsponse rate defined by RECIST criteria *

Study design

Patient characteristics

Progression-free survival analysis: Well-balanced treatment arms.

• Patient groups were well balanced for age, ECOG performance status, risk category, and prior cytokine therapy

* RECIST criteria: Complete response (CR) = disappearance of all target lesions, confirmed at 4 weeks; Partial response (PR) = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD) = at least a 20% increase in the sum of the LD of target lesions; no CR, PR, or SD documented before increased disease.

† Four patients were previously treated with chemotherapy.

‡ MSKCC: Memorial Sloan-Kettering Cancer Center (also known as Motzer criteria).