Rocapuldencel-T: Additional Ph III ADAPT data

A post hoc analysis of the first 154 patients with newly diagnosed metastatic RCC enrolled in the open-label, international Phase III ADAPT trial showed that 8 intradermal injections of rocapuldencel-T over 1 year followed by quarterly boosters plus standard of care (SOC), including Sutent sunitinib, led to an estimated median OS of 30.1 months vs. 22.2 months for SOC alone (HR=0.88, 95% CI: 0.56, 1.36). ADAPT completed enrollment of 462 patients in July 2015.

In February, an IDMC recommended ADAPT be discontinued for futility based on a planned interim analysis (see BioCentury, Feb. 23). The analysis showed that rocapuldencel-T plus SOC led to an estimated median 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. At the time, Argos said the trial would remain open while the company meets with FDA and conducts additional analyses. In 2015, Argos granted Chongqing Lummy rights to rocapuldencel-T in greater China for oncology indications (see BioCentury, April 20, 2015)...