An Argos Therapeutics therapy that uses the immune system to fight kidney cancer has hit a wall after an analysis of the latest clinical trial data found that the experimental treatment was unlikely to work.
Following the planned interim analysis of Argos’s (NASDAQ: ARGS) Phase 3 clinical trial, the independent data monitoring committee recommended stopping the study for futility, the company announced this morning. Shares in Durham, NC-based Argos plummeted more than 62 percent to $1.65 on the news.
Argos makes its immunotherapy, called rocapuldencel-T, by removing samples of a patient’s tumor and dendritic cells, which are the cells that start the body’s immune response. The dendritic cells are then programmed to target the cancer and infused back into the patient. Argos was studying its experimental treatment in renal cell carcinoma, a form of kidney cancer. The clinical trial enrolled 462 patients who received the immunotherapy along with the drug sunitinib (Sutent), the standard of care for the cancer.
The primary goal of the trial was improving overall survival of patients. But the data monitoring committee’s analysis concluded the Argos therapy was unlikely to demonstrate a statistically significant improvement on that measure, Argos said.
Argos said that it is analyzing the preliminary data from the clinical trial and it plans to discuss that information with the FDA. In the meantime, Argos said that it plans to leave the clinical trial open.
Renal cell carcinoma image by the CDC.