According to results from a phase 3 trial, darolutamide plus androgen-deprivation therapy and docetaxel improved the overall survival (OS) of patients with metastatic hormone-sensitive prostate cancer regardless of disease volume or disease risk, compared with placebo plus androgen-deprivation therapy and docetaxel.

Maha H. A. Hussain, MD, Feinberg School of Medicine at Northwestern University, Chicago, IL, presented these results on Thursday, February 16, 2023, at the 2023 ASCO Genitourinary Cancers Symposium in San Francisco, CA.

It has previously been reported, in the phase 3 ARASENS trial, that darolutamide added to androgen-deprivation therapy and docetaxel significantly reduced the risk of death by 32.5% among patients with metastatic hormone-sensitive prostate cancer, compared with placebo plus androgen-deprivation therapy and docetaxel. This benefit was seen across all prespecified subgroups, including patients with de novo and recurrent disease.

There were 1305 patients within this population in the full analysis set of the ARASENS trial, randomized on a 1-to-1 basis to receive androgen therapy and docetaxel plus either 600mg darolutamide twice daily (n = 651) or placebo (n = 654). Of the patient in the full analysis set, 777% had high-volume disease, 70% had high-risk disease, 23% had low-volume disease, and 30% had low-risk disease. The OS benefit of darolutamide vs placebo was seen in patients with both high- (hazard ratio [HR], 0.68) and low-volume (hazard ratio [HR], 0.69), and high- and low-risk disease.

Incidences of treatment-related adverse events were consistent across all disease volumes and disease risks. As reported previously, there were also similar overall incidences of treatment-related adverse events between the darolutamide and placebo arms.

Dr Hussain and coauthors concluded, “The benefits of early treatment intensification with [darolutamide plus androgen-deprivation therapy and docetxel] on OS…vs [placebo plus androgen-deprivation therapy and docetaxel] were similar in patients with high- and low-volume as well as high- and low-risk [metastatic hormone-sensitive prostate cancer],” adding this regimen “sets a new standard of care for [patients] with [metastatic hormone-sensitive prostate cancer].”

Source:

Hussain MHA, 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 Genitourinary Cancers Symposium; February 17-19; San Francisco, CA. Abstract 15