Nubeqa Plus Hormone Therapy May Slow Prostate Cancer Progression

Nubeqa plus androgen deprivation therapy may improve prostate cancer outcomes, according to recent research.

Among patients with metastatic hormone-sensitive prostate cancer, the treatment combination of Nubeqa (darolutamide) and androgen deprivation therapy (ADT) has reportedly displayed positive results regarding radiological progression-free survival (the time a patient lives without their disease spreading or worsening).

Topline data from the phase 3 ARANOTE trial announced by manufacturer, Bayer, stated that the combination met the trial’s primary endpoint (the main studied result of a trial) by demonstrating “a statistically significant and clinically meaningful” increase in radiological progression-free survival compared to placebo plus androgen deprivation therapy, according to a news release from the company.

Metastatic cancer is cancer that has spread from where it started to another part of the body. Hormone-sensitive prostate cancer requires male hormones, or androgens, to grow, according to the National Cancer Institute.

Learn more: Adding Nubeqa to Therapy May Reduce PSA Levels in Metastatic Hormone-Sensitive Prostate Cancer

“We are excited to share the positive results from this Phase 3 trial. Following potential regulatory approval, physicians will be able to tailor Nubeqa treatment plans with or without docetaxel [chemotherapy] based on [an] individual patient’s needs,” Christian Rommel, the head of research and development at Bayer’s Pharmaceuticals Division, said in the company’s news release. “Today’s results build on the established efficacy and tolerability profile of Nubeqa. We are looking forward to future outcomes of our clinical development program investigating the compound across multiple prostate cancer stages and indications.”

Nubeqa was approved by the Food and Drug Administration for the treatment of non-metastatic castration-resistant prostate cancer in 2019, and was then approved in combination with docetaxel for metastatic hormone-sensitive prostate cancer in 2022. According to the National Cancer Institute, the drug, an androgen receptor inhibitor, is indented to inhibit the growth of androgen receptor-expressing prostate cancer cells.

In the phase 3 ARANOTE trial assessing the safety and efficacy of Nubeqa and androgen deprivation therapy, 669 patients have been randomly assigned to receive either 600 milligrams of Nubeqa twice a day or placebo as well as androgen deprivation therapy, according to the news release. The study is estimated to be completed in September of 2025, according to its listing on clinicaltrials.gov.

Androgen deprivation therapy, according to the National Cancer Institute, is a form of treatment that reduces the androgen produced by the testicles. It is both the most commonly used hormone therapy for prostate cancer and the first form of hormone therapy many patients with prostate cancer receive.

Results of the trail, according to Bayer, have been consistent with Nubeqa’s established safety profile, and no new safety signals have been observed. The company stated that detailed results from the trial will be presented at an upcoming scientific meeting.

Learn More: Nubeqa, Hormone Therapy May Reduce Hospitalizations in Prostate Cancer

Earlier this year, the addition of Nubeqa to docetaxel and androgen deprivation therapy was shown to lower hospitalization rates among patients with metastatic hormone-sensitive prostate cancer but was also seen to possibly marginally increase the length of a patient’s hospital stay when compared with placebo, according to results from the ARASENS study which were presented at the 2024 ASCO Genitourinary Cancer Symposium.

Nubeqa is being evaluated in a number of stages of prostate cancer, including, in addition to the ARANOTE trial, the phase 3 ARASTEP trial evaluating Nubeqa plus androgen deprivation therapy versus standalone androgen deprivation therapy in patients with hormone-sensitive prostate cancer with high-risk biochemical recurrence, no evidence of metastatic disease and a positive PSMA (a protein found in elevated amounts on prostate cancer cells) test at baseline and the phase 3 DASL-HiCaP trial evaluating Nubeqa as a postsurgical treatment for patients with localized (cancer that has not spread to other parts of the body or nearby lymph nodes) prostate cancer with very high risk of recurrence.

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