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Expansion of global clinical program for darolutamide in prostate cancer.- Orion + Bayer.

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Published:24th Mar 2023

Bayer further expands the global clinical development program for the oral androgen receptor inhibitor (ARi) darolutamide in prostate cancer. The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide 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 after primary treatment (surgery or radiotherapy). darolutamide is already approved under the brand name nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmcrpc), who are at high risk of developing metastatic disease as well as metastatic hormone-sensitive prostate cancer (mhspc). bayer estimates that the peak sales potential for nubeqa will exceed €3 billion.></12>

"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. "Darolutamide 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 darolutamide in earlier disease stages."

The study is part of a robust global clinical development program for darolutamide. The compound is also being investigated in further studies across various stages of prostate cancer, including in the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC), as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

Condition: Prostate Cancer
Type: drug

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