In April of this year, Argos Therapeutics reported interim results from its Phase 3 ADAPT clinical trial of rocapuldencel-T in combination with the normal standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma.
Unfortunately, the results found that 75% of the targeted number of deaths for analysis of the primary goal of overall survival for the study had occurred. With this in mind, the Independent Data Monitoring Committee (IDMC) recommended that the study be discontinued for ineffectiveness.
Despite this recommendation, Argos decided to continue with the trial of rocapuldencel-T, pending further review and data analysis with the US FDA. This decision was not taken lightly, and Argos used the degree of maturity of the data set, and the nature and safety of rocapuldancel-T to determine that the trial should be continued to completion.
Argos planned to meet with the FDA in the months following this interim data, and now, with new financing for the trial courtesy of Pharmstandard, it looks like the ADAPT trial can continue.
Needless to say, it will be very interesting to see the final data from these studies and if Argos made the correct calculated risk in their decision to continue with ADAPT.
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