Bayer’s prostate cancer drug Nubeqa (ingredient: darolutamide) has improved the survival of men with non-metastatic castration-resistant prostate cancer (nmCRPC), the company said.

The New England Journal of Medicine published the final overall survival (OS) data of the phase-3 ARAMIS study on Nubeqa on Wednesday.

The ARAMIS study tested Nubeqa’s safety and efficacy on 1,509 patients by comparing the combination therapy of Nubeqa and androgen deprivation therapy (ADT) with ADT alone. After researchers lifted the blinding, they allowed cross-administration of ADT and Nubeqa for the group of ADT alone.

The study results demonstrated that the combo treatment group’s OS improvement was statistically meaningful. The addition of Nubeqa to ADT led to a 31 percent reduction in the risk of death.

The trial proved Nubeqa’s effect even when the researchers allowed cross-administration of the drugs. More than half (56 percent) of the patients treated with ADT alone showed clinical improvement after receiving follow-up treatment with Nubeqa or life-extending therapy.

The final analysis also confirmed that it was unlikely the Nubeqa and ADT combo would affect the mental nervous system to cause intellectual and cognitive disorders. It was presumed to be associated with the low blood-brain barrier (BBB), identified in preclinical studies on Nubeqa and healthy people.

“Through continuous research, we confirmed that the key to nmCRPC treatment is to prolong the life of patients and reduce adverse reactions,” said lead author Karim Fizazi, who is a medical professor at the Institut Gustave Roussy of Université Paris-Sud in France.

“This encouraging outcome shows that Nubeqa is an additional treatment option for physicians to meet the diverse needs of patients, such as improving therapeutic effects, survival, and drug tolerability management.”