Rocapuldencel-T: Ph III ADAPT data

An independent DMC recommended discontinuation for futility of the open-label, international Phase III ADAPT trial evaluating 8 intradermal injections of rocapuldencel-T over 1 year followed by quarterly boosters plus standard of care (SOC), including Sutent sunitinib, in 462 patients with metastatic RCC. The DMC said the combination was unlikely to meet the primary endpoint of improving overall survival (OS) vs. SOC alone based on a planned interim analysis. Rocapuldencel-T was generally well tolerated. Argos said the trial will remain open while the company meets with FDA and conducts additional analyses...