WASHINGTON -- Darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) significantly improved outcomes compared with ADT alone in men with metastatic hormone-sensitive prostate cancer (mHSPC), the phase II ARASEC trial showed.
In the study, which used an external control arm from the historic CHAARTED trial, median progression-free survival (PFS) was not estimable with the combination of darolutamide plus ADT compared with 14.3 months with ADT alone (HR 0.29, 95% CI 0.20-0.40, P<0.001), reported Rana McKay, MD, of the University of California San Diego, at the American Urological Association annual meeting.
Median overall survival (OS) was also significantly improved in the darolutamide group (HR 0.50, 95% CI 0.30-0.82, P=0.003), with 2-year OS rates of 89% and 80% in the darolutamide and ADT-alone arms, respectively. This OS benefit was achieved despite proportionally more patients in the ADT-alone arm receiving subsequent life-prolonging therapies (65% vs 26%).
Additionally, prostate-specific antigen (PSA) response rates were more than doubled in the darolutamide arm compared with the ADT-alone arm at all time points, with 68% versus 33% of patients achieving a PSA of less than 0.2 ng/mL at any time during the study (P<0.001).
