The ARAMIS trial evaluated the investigational treatment darolutamide. The trial showed great results including delaying the initial onset (actually the visualization by current scanning technology) of metastatic disease in prostate cancer.
In addition, ARAMIS showed that darolutamide increased overall survival for men with prostate cancer, it delayed the time to the use of cytotoxic chemotherapy as well as improving the important quality of life (QoL) measures of time to pain progression, and time to developing a symptomatic skeletal-related event.
The incidence of adverse events that occurred or worsened during the treatment period as well as the incidence of men dropping out of the trial was also similar between the investigation and the control arms of the trial.
Also, notable, the trial showed that darolutamide was not associated with a higher incidence of seizures, falls, fractures, cognitive disorder, or hypertension than placebo, a problem for similar drugs in the M0 space.
Overall, patient-reported quality of life was similar in the darolutamide group and placebo group.
Cancer ABCs hails the development of darolutamide. We have spoken with Bayer Pharmaceuticals about the current status of darolutamide, they have told us that they have submitted the required paperwork to the FDA in order to obtain the approval of darolutamide. Since the FDA has fast tracked the treatment we are hopeful that we can see an approval as soon as October of 2019.