Bayer (BAYRY.US) announced that its phase 3 ARANOTE trial met its primary endpoint. The oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide, darolutamide) in combination with androgen deprivation therapy (ADT) significantly improved the radiographic progression-free survival (rPFS) in metastatic hormone-sensitive prostate cancer (mHSPC) patients. Bayer plans to present key data at an upcoming scientific meeting and discuss these data with the US FDA for relevant regulatory approval.

Prostate cancer is the most common cancer in men worldwide. At diagnosis, most men have localized prostate cancer, which can be treated with surgery or radiation therapy. When the disease has spread or metastasized, it becomes metastatic prostate cancer. Prostate cancer cells grow in an androgen-dependent manner, so metastatic prostate cancer patients are initially sensitive to ADT, i.e. mHSPC. Patients who progress despite continued ADT develop metastatic castration-resistant prostate cancer (mCRPC).

Nubeqa is an oral androgen receptor inhibitor with a unique chemical structure that binds to the androgen receptor with high affinity and shows robust antagonist activity, thereby inhibiting receptor function and prostate cancer cell growth. Nubeqa was developed by Bayer and Orion and is approved in the US for use in combination with docetaxel to treat mHSPC in adult patients and for the treatment of nmCRPC in adult patients. The medicine is also approved in over 60 countries and territories worldwide, including the EU, Japan, and China.