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An independent data monitoring committee (IDMC) has recommended that the phase 3 ADAPT trial exploring rocapuldencel-T (AGS-003) for the first-line treatment of metastatic renal cell carcinoma (mRCC) be stopped because the trial is unlikely to show an improvement in overall survival. However, consistent with earlier phase 2 studies, rocapuldencel-T appears 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.
But the manufacturer, Argos Therapeutics, plans to keep the trial open to conduct further data analyses. “We are extremely disappointed with these results, which included 75 percent of the targeted events needed to permit the primary analysis and assessment of overall survival in the study,” said Jeff Abbey, president and chief executive officer of Argos Therapeutics. “We sincerely appreciate the patients and investigators who have participated in the ADAPT phase 3 trial, and remain convinced in the ability of precision immunotherapy to improve the lives of patients.”