Results of Phase III PROSPER trial in Xtandi for prostate cancer published in New England Journal of medicine.- Astellas Pharma.

Astellas Pharma announced that results from the pivotal Phase III PROSPER trial, which evaluated Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT in patients with non-metastatic castration-resistant prostate cancer (CRPC), were published in the New England Journal of Medicine. In the study, enzalutamide plus ADT significantly reduced the risk of developing metastases or death compared to ADT alone: 23% of patients in the enzalutamide and ADT arm had metastasis or had died, vs 49% in the ADT alone arm. The primary endpoint of median metastasis-free survival (MFS) was 36.6 months for men who received enzalutamide compared to 14.7 months with ADT alone (n=1401; HR=0.29 [95% CI: 0.24-0.35]; p<0.001).