Efficacy and safety of darolutamide in combination with androgen deprivation therapy and docetaxel in European patients from the phase 3 ARASENS trial.

BACKGROUND

In ARASENS, risk of death was significantly reduced by 32.5% with darolutamide in combination with androgen deprivation therapy (ADT) and docetaxel (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.57-0.80; p < 0.001) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We assessed efficacy and safety of darolutamide in European patients from ARASENS.

METHODS

Patients were randomized 1:1 to darolutamide 600 mg or placebo twice daily in combination with ADT and docetaxel. Primary endpoint was overall survival. Secondary endpoints included time to metastatic castration-resistant prostate cancer (mCRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent systemic antineoplastic therapy, and safety.

RESULTS

In ARASENS, 472 (36%) patients were from Europe; 240 received darolutamide and 232 received placebo. Patient baseline characteristics were similar to those of the overall population. Darolutamide reduced the risk of death by 37% (HR, 0.63; 95% CI, 0.48-0.83), and delayed time to mCRPC, time to pain progression, time to first SSE, and time to initiation of subsequent systemic antineoplastic therapy compared with placebo. Incidences of serious treatment-emergent adverse events (TEAEs) were lower with darolutamide versus placebo (37.9% vs. 43.1%) compared with the overall population (44.8% vs. 42.3%).

CONCLUSION

In European patients with mHSPC, darolutamide improved overall survival and secondary endpoints including time to mCRPC and time to pain progression. Darolutamide was well tolerated with similar incidence of TEAEs between treatment groups. Efficacy and safety findings in European patients were consistent with the overall ARASENS population.