Phase III data on AGS 003 in metastatic renal cell carcinoma shows immune response.- Argos Therapeutics.

Argos Therapeutics provided an update on the immunology data from the February 2017 interim analysis of data from the ongoing Phase III ADAPT clinical trial evaluating AGS 003 (rocapuldencel-T) for the treatment of metastatic renal cell carcinoma (mRCC). In subjects for whom immune response data were analyzed (n=146), the number of antigen-specific memory T-cells was found to increase only after administration of Rocapuldencel-T. In those subjects who received at least seven doses of Rocapuldencel-T (n=100), the average number of antigen-specific memory T-cells after the seventh dose was approximately double the number observed before treatment. This increase was found to be statistically significant. Similar data on a smaller number of patients were presented at the European Society for Medical Oncology Conference in September 2017.

Additionally, for those subjects who received at least seven doses of rocapuldencel-T, there was a statistically significant correlation between survival and the change in the number of antigen-specific memory T-cells from baseline (Spearman’s Rho = 0.40). For those 25 patients with the greatest increase in the number of antigen-specific memory T-cells from baseline, no patient deaths had been recorded as of the time of the February 2017 interim analysis.

The data are generally supportive of the company's hypothesis regarding the intended mechanism of action of Rocapuldencel-T to induce an immune response against the tumor in patients with metastatic renal cell carcinoma. Further data from the next planned interim data analysis is expected during the first half of 2018, pending agreement with the FDA on a revised protocol. Data were presented in the poster session at the 32nd Annual Meeting of the Society for Immunotherapy of Cancer.