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Non-metastatic RCC:
Approximately 70-80% of RCC patients present with non-metastatic disease at the time of first diagnosis. Standard therapy for non-metastatic RCC is surgical removal (partial or total) of the affected kidney (nephrectomy) followed by observation.

However, nearly 40% of patients, who have undergone surgery, experience a reccurence within two years. These patients, who can be identified using certain criteria, likely had undetectable cancer cells, which, untreated, grew to detectable metastases.

Even though many of the patients receiving surgery suffer a relapse, there are no approved medical treatments in the immediate post surgery period, also known as adjuvant therapies. Thus, there is a high unmet medical need for an adjuvant therapy after surgery to avoid or prolong the time to relapse.

Metastatic RCC:
Approximately 15% of RCC patients have detectable metastatic disease at the time RCC is diagnosed. In addition, many of the patients who have initially been diagnosed with non-metastatic RCC and received surgery suffer from a metastatic relapse. Recurrent and advanced stages of RCC are extremely difficult to treat: Therapies approved up until now have not been successful in the majority of cases and often have severe side-effects. Life expectancy for those patients is low.