Nubeqa success in Phase III prostate cancer study - PharmaTimes

Bayer and Orion’s joint drug Nubeqa (darolutamide) has been found to significantly improve overall survival rates in men with non-metastatic castration-resistant prostate cancer.

Last year the drug also garnered US Food and Drug Administration (FDA) approval based on the ARAMIS trial, a randomised, double-blind, placebo-controlled, multi-center Phase III study.

In the trial, Nubeqa plus androgen deprivation therapy (ADT) demonstrated a statistically significant improvement in metastatis-free survival, with a median metastatis-free survival of 40.4 months versus 18.4 months with placebo plus ADT.

More results from the oral androgen receptor inhibitor (ARi) are set to be announced at an upcoming scientific meeting, however the companies previously indicated that "a positive trend in overall survival" had also been seen, with an interim analysis demonstrating a 29% reduction in the risk of death for Nubeqa.

The compound, which is developed jointly by Bayer and Orion, has a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.

Prostate cancer that is treated with ADT but keeps progressing even when the amount of testosterone is reduced to very low levels in the body is known as castration-resistant prostate cancer.

Prostate cancer is the fifth leading cause of death from cancer in men. It results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system, mainly affects men over the age of 50, and the risk increases with age.