An independent data-monitoring committee for the pivotal phase 3 ADAPT trial of rocapuldencel-T (Argos Therapeutics) in combination with sunitinib/standard-of-care for the treatment of patients with metastatic renal cell carcinoma (mRCC) has recommended that the trial be discontinued for futility based on its planned interim data analysis. The committee concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination treatment arm, the study’s primary endpoint.
Rocapuldencel-T is an individualized immunotherapy that is designed to capture mutated and variant antigens that are specific to each patient’s tumor and induce an immune response targeting that patient’s tumor antigens. The randomized ADAPT trial evaluating rocapuldencel-T plus sunitinib/standard-of-care therapy versus standard-of-care therapy alone in newly diagnosed mRCC patients was opened in January 2013 and completed enrollment in July 2015. A total of 462 mRCC patients entered the study.
Argos Therapeutics is analyzing the preliminary ADAPT trial data set and plans to discuss the data with the FDA. The company is leaving the ADAPT trial open while it conducts its ongoing data review and discussions with the agency. Based on these analyses and discussions, the company will make a determination as to the next steps for the rocapuldencel-T clinical program.
Source: Argos Therapeutics; February 22, 2017.