Argos Therapeutics nosedives as rocapuldencel-T fails in Phase III
Shares of US immuno-oncology firm Argos Therapeutics (Nasdaq: ARGS) fell as much as 72% and ended Wednesday down 66.5% at $1.48 after the company announced a major setback in the development of its investigational kidney cancer drug rocapuldencel-T.
The Independent Data Monitoring Committee (IDMC) for the company’s pivotal Phase III ADAPT clinical trial of rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of metastatic renal cell carcinoma (mRCC) has recommended that the study be discontinued for futility based on its planned interim data analysis.
The IDMC concluded that the study was unlikely to demonstrate a statistically-significant improvement in overall survival in the combination treatment arm, utilizing the intent-to-treat population, the primary endpoint of the study. The IDMC noted that rocapuldencel-T was generally well-tolerated in the trial.
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