Bayer and Orion said Thursday that results from the Phase III ARAMIS study showed that Nubeqa (darolutamide) significantly improved overall survival compared to placebo in men with non-metastatic castration-resistant prostate cancer. The non-steroidal androgen receptor inhibitor is currently approved in the US, Brazil and Japan based on data from the trial demonstrating a significant improvement in metastasis-free survival.
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. Bayer and Orion noted Thursday that detailed data on the updated overall survival results, which come from a preplanned final analysis, will be presented at an upcoming scientific meeting.
Bayer and Orion are jointly developing Nubeqa, with filings for the oral drug also under review in the European Union and other countries. A Phase III study, dubbed ARASENS, investigating Nubeqa in metastatic hormone-sensitive prostate cancer is also ongoing.
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