This week seems to be a Darolutamide (Nubequa) celebration on our blog. On April 7th, we posted a blog post, “Darolutamide Provides Additional Overall Survival And Safety For Men With Non-Metastatic Castrate Resistant Prostate Cancer (CRPC) Who Also Have Co-Morbidities.
Today’s post is also about darolutamide (Nubeqa). Nubeqa is a potent androgen-receptor inhibitor; this means that it prevents any hormones produced by the body from gaining access to and supporting the cancer cell. Nubeqa has been shown to increase the overall survival among men with nonmetastatic, castration-resistant prostate cancer.
The question has come up, would combining Nubeqa, androgen-deprivation therapy (ADT), and docetaxel chemotherapy increase survival among men with metastatic, hormone-sensitive prostate cancer?
There was an international, randomized phase 3 trial of men with metastatic, hormone-sensitive prostate cancer to gain insight into this question. The trial assigned some men to receive darolutamide (at the standard dose of 600 mg [two 300-mg tablets] twice daily) or a placebo, both in combination with androgen-deprivation therapy (ADT) and docetaxel chemotherapy. The primary endpoint was overall survival.
RESULTS
The trial analyzed data from 1306 men (651 in the darolutamide group and 655 in the placebo group); 86.1% of the men had metastatic disease at the time of their initial diagnosis. Data showed that the risk of death was significantly lower, by 32.5%, in men who had received darolutamide than in those who received a placebo).
Adverse events experienced by both groups were similar. The frequency of grade 3 or 4 adverse events was 66.1% in the darolutamide group and 63.5% in the placebo group.
CONCLUSIONS
The good news is that in this trial, in men with metastatic, hormone-sensitive prostate cancer, their overall survival was significantly longer with the combination of darolutamide (Nubeqa), androgen-deprivation therapy (ADT), and docetaxel chemotherapy than with placebo plus androgen-deprivation therapy and docetaxel. The frequency of adverse events was similar in the two groups. (This trial was funded by Bayer and Orion – (NCT02799602)
