Most nmCRPC Patients Can Safely Take Full Dose of Nubeqa, Trial Analysis Shows

Most nmCRPC Patients Can Safely Take Full Dose of Nubeqa, Trial Analysis Shows
Nearly all men with non-metastatic castration-resistant prostate cancer (nmCRPC) received the full planned dose of Nubeqa (darolutamide) tablets while participating in the ARAMIS Phase 3 trial, and few required dose adjustments or discontinued treatment, according to a new ad-hoc analysis of the study. Findings from this analysis were recently presented in an e-poster, titled "Tolerability and treatment response to darolutamide (DARO) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in the phase III ARAMIS trial," at the ESMO Virtual Congress 2020, held online Sept. 19–21. Nubeqa, jointly developed by Bayer and Orion, is an oral medication approved for men with nmCRPC. The medication works by inhibiting androgen receptors — proteins found on the surface of cells that bind to male hormones — and interrupting the androgen signaling cascade, which promotes the growth of prostate cancer cells. Nubeqa’s approval last year was based on data from the ARAMIS trial (NCT02200614), which compared the safety and efficacy of Nubeqa plus androgen deprivation therapy (ADT) to those of a placebo plus ADT in a group of 1,509 nmCRPC patients. The trial was funded by Bayer and Orion. A primary analysis of the study showed that adding Nubeqa to standard ADT prolonged the time patients lived without having their cancer spread from 18.4 to 40.4 months, lowering the risk of cancer spreading or death by 59%. Nubeqa also prolonged the time patients lived without their disease worsening from 14.8 to 36.8 months, reducing the risk of disease progression or death by 62%. The incidence of side effects was found to be similar in the two treatment groups. The addition of Nubeqa to ADT did not increase the frequency of serious side effects,
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