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Argos Therapeutics has abandoned its phase 3 trial of rocapuldencel-T (a kidney cancer vaccine) in combination with sunitinib in patients with newly diagnosed metastatic renal cell carcinoma (mRCC) due to lack of efficacy.
Last year, an independent data monitoring committee (IDMC) recommended that the phase 3 ADAPT trial exploring rocapuldencel-T (AGS-003) for the first-line treatment of mRCC be stopped because the trial was unlikely to show an improvement in overall survival. However, consistent with earlier phase 2 studies, rocapuldencel-T appeared to be well tolerated.
The ADAPT trial recruited 462 metastatic RCC patients, who were randomised to receive rocapuldencel-T plus standard therapy (mostly sunitinib) or standard therapy alone. The combination treatment failed to improve overall median survival compared to standard treatment (28.2 months versus 31.2 months).
But the manufacturer, Argos Therapeutics, kept the trial open until now to conduct further data analyses and for discussions with the US Food and Drug Administration.