NEJM: 31% reduction in risk of death The new prostate cancer drug drarolutamide improves survival.

Screenshot Source: New England Journal of Medicine Darolutamide (Nubeqa) is an oral androgen-infused antagonist (ARi) developed by Bayer and Orion to inhibit androgen-like body function and the growth of prostate cancer cells.
it was approved by the FDA in July 2019.
applications for listing in China have also been included in the priority review by the Drug Review Center (CDE) of the State Drug Administration of China.
in the trial, called ARAMIS, 1,509 male patients were given a 2:1 group and received aarolutamide (955) or placebo (554) based on androgen deprivation therapy.
previously published results showed that the median non-transferable survival of patients in the darolutamide group was 40.4 months, significantly higher than the 18.4 months in the placebo group, reaching the main study endpoint of the trial.
the main endpoint as positive, the trial was blinded and patients in the placebo group were allowed to receive drarolutamide treatment across groups.
At the time of the revelation, all 170 patients who were still receiving placebo treatment had switched to drarolutamide; 137 patients who had been deactivated from the placebo before the test had received at least one other treatment, most commonly dositamine, acetic acid abphetron and encetrumide.
follow-up period was 29.0 months.
the latest data, the darolutamide group and the placebo group had a three-year total survival rate of 83% and 77%, respectively.
risk of death was significantly reduced by 31% compared to the placebo group in the Drarolutamide group.
darolutamide group also showed significant benefits at other secondary endpoints, including the time of the first symptomatic skeletal event and the time of the first use of cytotoxic chemotherapy.
rates of adverse events were similar between the two groups, and no new safety signals were observed.
team concluded that the overall survival benefits of patients in the drarolutamide group were observed even if more than half (55 percent) of the placebo group followed up with drarolutamide or other treatments.
references: s1. Karim Fizazi, et al., (2020). Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med, DOI: 10.1056/NEJMoa2001342 ( 2 ) Darolutamide boosts survival in nonmetastatic prostate cancer. Retrieved September 16, 2020, from.