Rocapuldencel-T is prepared from dendritic cells, co-electroporated with tumor and CD40L RNA. This pivotal Phase 3 trial investigated the safety and efficacy of combination therapy dosing regimen of Rocapuldencel-T plus sunitinib in patients with mRCC.
Patients received either Rocapuldencel-T plus SOC or SOC treatment alone. The primary objective compared OS between groups. Secondary objectives included safety, PFS and tumor responses. Exploratory analyses included immunological assessments and correlates with OS.
462 patients were randomized 2:1, 307 to the combination group and 155 to the SOC group. Median OS in the combination and SOC groups was 27.7 months and 32.4 months respectively. PFS was 6.0 months and 7.8 months for the combination and SOC groups respectively. The ORR was 42.7% for the combination group and 39.4% for the SOC group. Immune responses were detected in 70% of patients treated with Rocapuldencel-T. The magnitude of the immune response correlated with OS. Additionally, we report the survival-predictive value of IL-12 produced by the DC vaccine and the observation that high baseline numbers of T regulatory cells are associated with improved outcomes in DC treated patients but are associated with poor outcomes in patients receiving SOC treatment.
Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the immune response correlated with OS. Moreover, we identified two potential survival-predictive biomarkers for patients receiving DC based immuno-therapy, DC vaccine produced IL-12 and higher numbers of T regulatory cells present in the peripheral blood of mRCC patients.

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