Even in the Prescence of Health Complications and Other Medications, Nubeqa Maintains Safety, Efficacy in Prostate Cancer Treatment

Nubeqa (darolutamide) is a safe and effective drug for patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) who have other health issues – known as comorbidities – or are taking other, concomitant medications, according to research presented at the 2022 ASCO Genitourinary Cancers Symposium.

For the study, patients with nmCRPC from the phase 3 ARAMIS trial were randomly selected to receive either Nubeqa (955 patients) or placebo (554 patients) while continuing treatment with androgen deprivation therapy. At the final data cut-off date of Nov. 15, 2019, overall survival (OS; the percentage of patients who were still alive) and side effects were evaluated in patients with a median of six or fewer or more than six comorbidities and 10 or fewer or more than 10 concomitant medications.

Comorbidities evaluated included metabolic, cardiovascular, and other (osteoarthritis and arthralgia and back pain, prostate enlargement, constipation and gastroesophageal reflux and renal insufficiency). Concomitant medication classes/subclasses included gastrointestinal/metabolic, cardiovascular (antihypertensives and non-antihypertensives), pain/inflammation, and urologic.

“More than 50% of the patients in the ARAMIS trial, which was a very significant number of patients…had a minimum of six or more comorbidities of significance,” commented study coauthor Dr. Neal D. Shore, in an interview with Urology Times®, a sister publication of CURE®. Specifically, 795 of the total cohort of 1,509 patients had at least six comorbidities, and 813 patients had received at least 10 concomitant medications.

The investigators reported that in patients with at least six and more than six comorbidities, Nubeqa prolonged OS compared with placebo. The OS benefit for Nubeqa was found to be consistent in patients with metabolic, cardiovascular and other comorbid conditions. OS was also prolonged in patients receiving up to 10 and more than 10 concomitant medications.

“Subgroups of (patients) receiving concomitant medications for gastrointestinal/metabolic disorders, CV disease, urologic disorders, and pain/inflammation achieved similar OS benefit with )Nubeqa vs placebo),” wrote the authors.

Regarding side effects, 447 patients with at least six comorbidities (83%) and 366 patients with more than six comorbidities (90%) experienced any side effect, compared to 242 (74%) and 195 patients (88%) receiving placebo, respectively.

A total of 127 patients with at least six comorbidities (24%) and 124 patients with more than six comorbidities (31%) experienced a grade 3 or 4 side effect, vs 58 (18%) and 61 (28%) patients receiving placebo, respectively. A total of 43 patients with at least six comorbidities (8%) and 42 patients with more than six comorbidities (10%) experienced an side effect leading to permanent study drug discontinuation, vs 20 (6%) and 28 patients receiving placebo (13%).

A total of 371 patients (77%) taking at least 10 concomitant medications and 442 patients taking more than 10 concomitant medications (95%) experienced any side effects, compared to 184 (68%) and 248 (91%) of patients receiving placebo, respectively.

Sixty-seven patients (14%) taking at least 10 concomitant medications and 183 patients (39%) taking more than 10 concomitant medications experienced a severe (grade 3 or 4) side effects, versus 36 (13%) and 82 patients (30%) receiving placebo, respectively.

Finally, 35 patients taking at least 10 concomitant medications (7%) and 50 patients taking more than 10 concomitant medications (11%) experienced a side effects leading to them stopping Nubeqa treatment, compared to 17 (6%) and 29 patients (11%) receiving placebo, respectively.

“I think what we're showing here is that the overall survival benefit, as well as the safety analysis, regardless of the number of comorbidities, was rather significant,” Shore said.

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