Phase 3 ARASTEP study to investigate darolutamide plus ADT for hormone-sensitive prostate cancer

The phase 3 ARASTEP study investigating the efficacy of Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) vs ADT alone in hormone-sensitive prostate cancer has been initiated, Bayer announced.¹

The randomized trial is expected to enroll 750 patients with hormone-sensitive prostate cancer.

The randomized trial is expected to enroll 750 patients with hormone-sensitive prostate cancer with high-risk biochemical recurrence (BCR), no evidence of metastatic disease by conventional imaging, and a positive prostate-specific membrane antigen PET/CT at baseline. BCR is defined as a rising prostate-specific antigen (PSA) level with a doubling time of less than 12 months and no evidence of metastatic disease. The primary end point of the study is radiological progression-free survival.

“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. Nubeqa has already demonstrated efficacy and safety in nmCRPC [nonmetastatic castration-resistant prostate cancer] with the phase 3 ARAMIS trial, and in mHSPC [metastatic hormone-sensitive prostate cancer] with the phase 3 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,” said Tara Frenkl, MD. Frenkl is the senior vice president and head of Oncology Development at Bayer.

In the US, darolutamide is currently indicated for the treatment of patients with nmCRPC and for the treatment of adult patients with mHSPC in combination with docetaxel.

ARAMIS and ARASENS Trial Data

Darolutamide was granted FDA approval in 2019 based on findings from the ARAMIS trial (NCT02200614), which evaluated the safety and efficacy of darolutamide in patients with nmCRPC.² Primary data from the trial showed that darolutamide led to a 59% reduction in the risk of metastases or death compared with the placebo cohort (P < .001).

FDA approval for darolutamide was also granted for use in combination with docetaxel for the treatment of patients with mHSPC. This approval was based on a primary analysis of findings from the ARASENS trial (NCT02799602), which showed that adding darolutamide to standard ADT and docetaxel boosted overall survival (OS) vs ADT/docetaxel alone in patients with mHSPC.

A recent secondary analysis of data from the study showed that darolutamide plus ADT and docetaxel prolonged OS regardless of disease volume or risk. Specifically, the risk of death was reduced by 32% across all volume and subgroups in men with mHSPC treated with the darolutamide-based triplet regimen.³

References

1. Bayer expands global clinical program for Nubeqa (darolutamide) in prostate cancer. News release. Bayer. Published online and accessed March 23, 2023. https://bayer2019tf.q4web.com/news/news-details/2023/Bayer-Expands-Global-Clinical-Program-for-NUBEQA-darolutamide-in-Prostate-Cancer/default.aspx

2. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246. doi:10.1056/NEJMoa1815671

3.Hussain M, Tombal BF, Saad F, et al. Efficacy and safety of darolutamide (DARO) in combination with androgen-deprivation therapy (ADT) and docetaxel (DOC) by disease volume and disease risk in the phase 3 ARASENS study. Presented at: 2023 ASCO GU Cancers Symposium. February 16-18, 2023. San Francisco, CA