The pharmaceutical company announced preliminary results on a phase 3 trial, which demonstrated that Nubeqa with docetaxel and androgen deprivation therapy may improve overall survival in men with metastatic hormone-sensitive prostate cancer.
Adding the oral androgen receptor inhibitor Nubeqa (darolutamide) with docetaxel and androgen deprivation therapy significantly increased survival compared to docetaxel and androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer, according to primary results from the phase 3 ARASENS trial.
In particular, Nubeqa with docetaxel and androgen deprivation therapy increased overall survival (the time from the start of treatment when a patient with cancer is still alive) compared with docetaxel and androgen deprivation therapy, which is considered standard of care for men with metastatic hormone-sensitive prostate cancer, according to a news release from Bayer, Nubeqa’s manufacturer.
“For patients with (metastatic hormone-sensitive prostate cancer), there remains a significant need for new therapeutic approaches that improve treatment outcomes,” said Dr. Scott Z. Fields, senior vice president and head of oncologist development at Bayer’s pharmaceutical division, in the release. “ARASENS was prospectively designed to investigate whether combining Nubeqa with docetaxel and (androgen deprivation therapy) could lead to an increase in overall survival for men with (metastatic hormone-sensitive prostate cancer).”
In the ARASENS trial, researchers are exploring Nubeqa plus docetaxel and androgen deprivation therapy in 1,306 patients with newly diagnosed, metastatic hormone-sensitive prostate cancer. Patients were randomly assigned either 600 milligrams of Nubeqa twice per day or placebo, along with docetaxel and standard androgen deprivation therapy. In addition to overall survival, other points of interest in the trial included time to castration-resistant prostate cancer, time to first symptomatic skeletal event, time to initiation of subsequent anticancer therapy and time to pain progression. These were assessed at 12-week intervals along with side effects, which helped researchers assess tolerability and safety of the combination.
According to the release, serious side effects occurred in 25% of patients treated with Nubeqa compared with 20% of those who received placebo in the ARASENS trial. Some serious side effects observed in at least 1% of patients in the Nubeqa group included pneumonia, urinary retention and blood in urine. Side effects led to death in 3.9% of patients assigned Nubeqa compared with 3.2% of those assigned placebo. Some of the causes of death were related to cardiac arrest (0.2%), cardiac failure (0.3%), pulmonary embolism (0.2%) and general physical health deterioration (0.2%). Other side effects that occurred more often in patients who received Nubeqa included pain in an extremity, fatigue and rash. In addition, some clinically significant side effects observed in at least 2% of patients treated with Nubeqa included heart failure and ischemic heart disease, according to the release.
Detailed results from the ARASENS trial may be presented at an upcoming oncology meeting, according to the release.
Of note, Nubeqa was previously approved by the Food and Drug Administration in July 2019 for the treatment of patients with non-metastatic, castration-resistant prostate cancer. This approval was based on findings from the ARAMIS trial, which compared 600 milligrams of Nubeqa with androgen deprivation therapy in 1,509 patients. Researchers are also assessing Nubeqa in other studies with patients of varying stages of prostate cancer.
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