Bayer met the primary endpoint in the Arasens Phase III trial to evaluate the oral androgen receptor inhibitor Nubeqa (darulutamide) in metastatic hormone-sensitive prostate cancer.
In the study, darulutamide in combination with docetaxel and androgen deprivation therapy (ADT) showed a significant increase in overall survival compared with docetaxel and ADT, Bayer said. The incidence of adverse events was similar in both treatment arms.
Bayer plans to present the results of the detailed study soon at a scientific conference.
Darolutamid under the brand name Nubeqa is approved for the treatment of patients with non-metastatic castration-resistant prostate cancer at high risk of developing metastases in the USA, the European Union, Japan and China, among others. Bayer has already submitted applications for approval for other regions or is in the planning stage. The product is jointly developed by Bayer and global pharmaceutical company Orion from Finland.
Bayer shares were temporarily down 1.24% in XETRA trading on Friday, to €44.38.
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