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Zhitong Finance APP learned that Bayer (BAYRY.US) announced that its Phase 3 ARANOTE trial reached its primary endpoint. Its oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) combined with androgen deprivation therapy (ADT) can significantly improve the radiological progression-free survival (rPFS) of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Bayer plans to release key data at an upcoming scientific conference and discuss these data with the US FDA to obtain relevant regulatory approval.

Prostate cancer is one of the most commonly diagnosed malignancies in men worldwide. At diagnosis, most men have localized prostate cancer, which can be treated with surgery or radiation therapy. When the disease metastasizes, or spreads, it develops into metastatic prostate cancer. Because prostate cancer cells grow in a way that is androgen-dependent, men with metastatic prostate cancer are initially sensitive to ADT treatment, known as mHSPC. Men whose disease progresses despite continued ADT develop metastatic castration-resistant prostate cancer (mCRPC).

Nubeqa is an oral androgen receptor inhibitor with a unique chemical structure that can bind to androgen receptors with high affinity, showing strong antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells. Nubeqa was jointly developed by Bayer and Orion and has been approved in the United States for combination with docetaxel for the treatment of adult patients with mHSPC and non-metastatic castration-resistant prostate cancer (nmCRPC). The drug has also been approved in more than 60 countries and regions around the world, including the European Union, Japan, and China.