Adding darolutamide to androgen deprivation therapy (ADT) and docetaxel improves overall survival for patients with metastatic hormone-sensitive prostate cancer (mHSPC), compared with ADT plus docetaxel alone, new research suggests.

These findings, from the phase 3 ARASENS trial, were presented at the ASCO Genitourinary Cancers Symposium 2022 and published concurrently in the New England Journal of Medicine.1,2

“Based on the results of ARASENS, we conclude that darolutamide in combination with ADT and docetaxel should become the new standard of care for the treatment of patients with mHSPC,” said Matthew R. Smith, MD, PhD, of Massachusetts General Hospital Cancer Center in Boston, when presenting the results at the meeting.


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The ARASENS trial (ClinicalTrials.gov Identifier: NCT02799602) included 1305 patients with mHSPC who were randomly assigned to receive darolutamide at 600 mg twice daily (651 patients) or placebo (654 patients), each in combination with ADT and docetaxel.

The treatment arms had similar demographics and clinical characteristics at baseline. The median age of patients in both groups was 67 years. The vast majority of patients — 85.7% in the darolutamide arm and 86.5% in the placebo arm — had metastatic disease at initial diagnosis.

The researchers found that darolutamide significantly decreased the risk of death by 32.5% (hazard ratio [HR], 0.68; 95% CI, 0.57-0.80; P <.001) compared with placebo.

The overall survival rate at 4 years was 62.7% in the darolutamide arm and 50.4% in the placebo arm. The survival benefit associated with darolutamide was consistent across prespecified subgroups, Dr Smith reported.

In addition, darolutamide significantly delayed the development of castration-resistant prostate cancer (CRPC) and time to pain progression.

The median time to CRPC was 19.1 months in the placebo arm and was not reached in the darolutamide arm (HR, 0.36; 95% CI, 0.30-0.42; P <.001). The median time to pain progression was 27.5 months in the placebo arm and was not reached in the darolutamide arm (HR, 0.79; 95% CI, 0.66-0.95; P =.01).

The 2 study arms had a similar incidence of treatment-related adverse events (TRAEs). The incidence of grade 3/4 TRAEs was 66.1% in the darolutamide arm and 63.5% in the placebo arm. The most common TRAE was neutropenia (33.7% and 34.2%, respectively).

Disclosures: This research was supported by Bayer in collaboration with Orion Corporation/Orion Pharma. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original references for a full list of disclosures.

References

  1. Smith MR, Hussain MHA, Saad F, et al. Overall survival with darolutamide versus placebo in combination with androgen-deprivation therapy and docetaxel for metastatic hormone-sensitive prostate cancer in the phase 3 ARASENS trial. Presented at ASCO GU 2022; February 17-19, 2022. Abstract 13.
  2. Smith MR, Hussain M, Saad F, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. Published online February 17, 2022. doi:10.1056/NEJMoa2119115

This article originally appeared on Cancer Therapy Advisor