Nubeqa, ADT Combo Should Be New Standard of Care for Some Patients With Prostate Cancer

Regardless of risk and volume status of a patient’s metastatic hormone-sensitive prostate cancer, Nubeqa (darolutamide) in combination with androgen-deprivation therapy (ADT) and docetaxel reduced the risk of death by about 32%, according to recent study results.

Prior research reported that the triplet therapy improved overall survival (time from diagnosis or treatment start when patients are alive) in the overall population, and these updated results suggest that the benefit is also observed among subgroup of patients with high- and low-risk, and high- and low- volume disease.

“Therefore, we conclude that (Nubeqa) with androgen deprivation and docetaxel should be considered a new standard of care of patients with metastatic hormone sensitive prostate cancer,” noted Dr. Maha H. A. Hussain, lead author on the study and a professor of medicine at Northwestern University Feinberg School of Medicine in Chicago, during a presentation of the results at the 2023 ASCO Genitourinary Cancers Symposium.

The study included 1,305 patients: 1,005 (77%) had high volume disease, 912 (70%) had high-risk disease, 300 (23%) had low-volume disease and 393 (30%) had low-risk disease. High-volume disease was defined as visceral metastases and/or at least four or more bone metastases with at least one or more beyond the vertebral column or pelvis.

High-risk disease was defined as at least two of these risk factors: Gleason score (A way of describing prostate cancer based on how abnormal the cancer cells in a biopsy sample look under a microscope and how quickly they are likely to grow and spread) of eight or more, three or more bone lesions, and presence of measurable visceral metastasis (metastases in the liver, lung, ascites [fluid build up in the abdomen], pleural effusion [fluid build up between the lung and chest cavity] and central nervous system).

Results of the ARASENS trial demonstrated that an average overall survival was not reached in both the high- and low- volume disease groups with the Nubeqa combination.Of note, when a median overall survival is not reached it is because it cannot be calculated because more than half of the patients were still living.

Median overall survival was also not reached in both the high- and low -risk disease subgroups with the Nubeqa combination.

The Nubeqa combination also clinically improved key secondary endpoints in high/low volume and risk subgroups, compared with placebo, with similar data of those observed in the general population.

This includes time to castration resistant to progression (prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels) which favors the Nubeqa combination, in both the high – and low- volume disease groups; as well as the high- and low-risk groups.

Incidence of side effects were consistent with the overall population across subgroups by high/low volume and high/low risk.

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