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Darolutamide improves OS in nmCRPC

Elaine Soliven
30 Dec 2020

Treatment with darolutamide significantly improved overall survival (OS) in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC), according to a prespecified final analysis of the ARAMIS* study presented at ESMO Asia 2020.

This phase III, multicentre, double-blind trial involved 1,509 patients with nmCRPC who were randomized in a 2:1 ratio to receive either darolutamide 600 mg twice daily (n=955) or placebo (n=554) in addition to androgen deprivation therapy (ADT). After unblinding, 170 patients in the placebo group crossed over to receive open-label darolutamide. [ESMO Asia 2020, abstract 740; N Engl J Med 2020;383:1040-1049]

At 3 years, the OS rate was higher in the darolutamide arm, with a 31 percent significant reduction in the risk of death, compared with the placebo arm (83 percent vs 77 percent; hazard ratio [HR], 0.69; p=0.003).

“The OS benefit was observed despite more than half of the patients in the placebo group receiving subsequent darolutamide or other life-prolonging therapy (docetaxel, abiraterone/abiraterone acetate, enzalutamide, sipuleucel-T, and cabazitaxel),” said lead author Dr Karim Fizazi from Institut Gustave Roussy and University of Paris-Saclay in Villejuif, France.

Darolutamide-treated patients also had significantly longer time to pain progression (median 40.3 vs 25.4 months; HR, 0.65; p<0.001), time to first use of cytotoxic chemotherapy (HR, 0.58; p<0.001), and time to first symptomatic skeletal event (HR, 0.48; p=0.005) at 3 years compared with placebo-treated patients.

Time to first prostate cancer-related invasive procedure (HR, 0.42; p<0.001) and time to initiation of subsequent antineoplastic therapy (HR, 0.36; p<0.001) were also significantly longer with darolutamide compared with placebo.

The incidence of treatment-emergent adverse events (AEs) was similar between the darolutamide and placebo arms (85.7 percent vs 79.2 percent). “With [this] extended follow-up, the safety profile of darolutamide was favourable and consistent with the primary analysis [that has been] previously reported. [Also,] incidences of most ARI**-associated AEs were not increased with darolutamide vs placebo, taking treatment exposure into account,” Fizazi said.

“[In conclusion,] darolutamide significantly improved OS vs placebo in men with nmCRPC, regardless of the effect of crossover (31 percent of men in the placebo group) and subsequent therapies ... [The study drug also] significantly delayed the onset of cancer-associated morbidity and subsequent chemotherapy,” noted Fizazi.

“These results provide further compelling evidence for early darolutamide treatment in men with nmCRPC,” he added.

 

*ARAMIS: Efficacy and safety study of darolutamide (ODM-201) in men with high-risk nonmetastatic castration-resistant prostate cancer

**ARI: Androgen receptor inhibitor

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Most Read Articles
02 Jun 2020
New drug applications approved by US FDA as of 16 - 31 May 2020 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date. 
Pearl Toh, Yesterday
While children with inflammatory bowel disease (IBD) see their conditions improve with biologic therapy, those with ulcerative colitis (UC) tend to have residual disease activity even after clinical remission, according to two separate studies presented at the 2021 Crohn’s and Colitis Congress.