FDA agrees with Argos' decision to continue Phase III of rocapuldencel-T

Argos Therapeutics Inc. (NASDAQ:ARGS) said FDA agreed with the company’s decision to continue the Phase III ADAPT trial evaluating rocapuldencel-T (AGS-003) in metastatic renal cell carcinoma (RCC) patients, despite an IDMC recommendation to discontinue the trial.

In February, an IDMC recommended ADAPT be discontinued for futility based on a planned interim analysis (see BioCentury, Feb. 27). The analysis showed that rocapuldencel-T plus standard of care (SOC) led to an estimated median overall survival (OS) of 27.7 months vs. 32.4 months for SOC alone (HR=1.1, 95% CI: 0.83, 1.46). The interim analysis was conducted after 75% of the targeted number of 290 deaths had occurred. In April, Argos reported data from a post hoc analysis of the first 154 patients enrolled in ADAPT showing that the treatment led to an estimated median OS of 30.1 months vs. 22.2 months for SOC alone (see BioCentury, April 24). ...