Bayer Expands Global Clinical Program for NUBEQA® (darolutamide) in Prostate Cancer

Bayer further expands the global clinical development program for NUBEQA (darolutamide) in prostate cancer. The new Phase III clinical study, ARASTEP, will investigate the efficacy of NUBEQA plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

BCR is defined as rising prostate-specific antigen (PSA) levels with a doubling time of <12 months and no evidence of metastatic disease by conventional imaging. NUBEQA is currently indicated in the U.S. for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

“Many patients with rising PSA levels following surgery or radiation are at an increased risk of developing metastasis. With ARASTEP, we are optimistic about the potential to help patients at this earlier stage of the disease,” said Tara Frenkl, M.D., Senior Vice President and Head of Oncology Development at Bayer, “NUBEQA has already demonstrated efficacy and safety in nmCRPC with the Phase III ARAMIS trial, and in mHSPC with the Phase III ARASENS trial. Our goal is to ensure that as many patients as possible benefit from this therapy, therefore we continue to assess the potential of NUBEQA in earlier disease stages.”