Long-term survival in unfavorable-risk mRCC patients treated with a combination of autologous immunotherapy (AGS-003) plus sunitinib.

4524^ Background: Treatment for metastatic renal cell carcinoma (mRCC) has evolved significantly over the last decade due to enhanced understanding of the biology of RCC resulting in availability of number of agents targeting the VEGF axis and mTOR pathway. These treatments however, usually do not elicit durable responses and may have significant toxicities. AGS-003 is an autologous immunotherapy designed to induce an immune response to patient’s own tumor. In a phase 2 trial, AGS-003 in combination with sunitinib was studied for safety and efficacy. Updated survival data is presented. Methods: In this open label, phase 2 study, subjects with newly diagnosed metastatic clear cell RCC were enrolled. Subjects received sunitinib (4wks on, 2wks off) combined with AGS-003 (every 3wks X 5 doses, then every 12wks) until progression. Subjects were followed for PFS and OS throughout the trial and during a rollover protocol. Results: For the twenty-one subjects (11 intermediate risk, 10 poor risk) treated, the medi...