Orion's and Bayer's darolutamide has shown substantial efficacy and a favourable safety profile in the treatment of prostate cancer in the ARAMIS trial.
The a novel oral androgen receptor antagonist in combination with androgen deprivation therapy (ADT) has been found to significantly extend metastasis-free survival (MFS) compared to placebo, with a 29% reduction in risk of death at interim analysis.
The median MFS was 40.4 months in the darolutamide arm, compared with 18.4 months for the placebo arm - an overall improvement in median MFS of 22 months.
"In addition to a benefit in MFS, a favourable safety profile is critical for these largely asymptomatic nmCRPC patients because treatment decisions can impact their overall well-being, prognosis, compliance with the treatment as well as other medications that are typical for this patient population.” said Karim Fizazi, Professor of Medicine at the Institut Gustave Roussy, University of Paris Sud, France.
He continued: “These data are exciting for the prostate cancer community; they not only show darolutamide's significant efficacy in preventing the spread of prostate cancer, but also its favourable tolerability profile that, once approved, may allow patients to continue their day-to-day life without adding any burden.”
Bayer has been granted Fast Track designation by the U. Food and Drug Administration (FDA) for darolutamide in men with nmCRPC, which is currently being developed jointly by Bayer and Orion Corporation.
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide, as in 2018 alone an estimated 1.2 million men were diagnosed with the disease, and about 358,000 died as a result worldwide.