Matching-adjusted indirect comparison of enzalutamide versus darolutamide doublet in mHSPC.

AIMS

To compare the efficacy of enzalutamide + androgen-deprivation therapy (ADT) versus darolutamide + ADT for treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) using a matching-adjusted indirect comparison (MAIC).

PATIENTS AND METHODS

Individual patient data from ARCHES (NCT02677896; enzalutamide + ADT,  = 1150) were weighted and adjusted to match published aggregated data on baseline characteristics from ARANOTE (NCT04736199; darolutamide + ADT,  = 669). The MAIC was anchored on the common comparator, placebo + ADT, and provided a (matching-adjusted) hazard ratio (HR) of enzalutamide versus darolutamide.

RESULTS

Treatment with enzalutamide + ADT significantly prolonged the primary endpoint of radiographic progression-free survival (HR [95% confidence interval, CI]: 0.54 [0.32-0.93],  = 0.03) and time to castration resistance (HR [95% CI]: 0.57 [0.34-0.94],  = 0.03) compared with darolutamide + ADT (effective sample size: 319). Time to prostate-specific antigen progression (HR [95% CI]: 0.61 [0.29-1.30],  = 0.20) and time to initiation of new antineoplastic therapy (HR [95% CI]: 0.65 [0.34-1.24],  = 0.19) favored enzalutamide over darolutamide, albeit the difference was not statistically significant.

CONCLUSIONS

Enzalutamide + ADT showed better efficacy than darolutamide + ADT for treatment of patients with mHSPC. These findings can help inform treatment decisions in clinical practice.