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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 of the affected kidney (nephrectomy) followed by observation. However, nearly 40% of patients, who have undergone surgery, experience a reccurence within 2 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.