Largest head-to-head real-world study in mCSPC demonstrated that ERLEADA reduced risk of death by 23 percent at 24 months compared to enzalutamide
LISBON, Portugal, Oct. 2, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the results of a landmark real-world, head-to-head study showing that ERLEADA (apalutamide) provided a statistically significant overall survival benefit at 24 months compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC). Presented at the 6th European Congress of Oncology Pharmacy (ECOP) in Lisbon, Portugal, on October 2 (Abstract #P31), this study of nearly 4,000 patients represents the largest real-world, head-to-head analysis of these two androgen receptor pathway inhibitors (ARPIs) in mCSPC.
The study applied U.S. Food and Drug Administration (FDA) real-world evidence guidance and employed robust methodology, data sources and a large, diverse cohort to ensure validity of its findings. The retrospective study identified mCSPC patients who initiated ERLEADA or enzalutamide between December 16, 2018 – December 31, 2023, based on patient data in electronic databases. There were 1,800 ERLEADA and 1,909 enzalutamide initiators who met study criteria.
The analysis demonstrated patients with mCSPC who initiated ERLEADA as their first ARPI had a statistically significant 23 percent reduction in their risk of death at 24 months compared to patients who initiated on enzalutamide (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62-0.96; P<0.019). The proportion of patients alive at 24 months (87.6 percent) observed in the ERLEADA cohort in this real-world analysis is consistent with that in the Phase 3 TITAN trial (82.4 percent).1 TITAN demonstrated a statistically significant superior overall survival benefit of ERLEADA plus androgen deprivation therapy (ADT) compared to ADT alone at the primary analysis after a median 22.7 months of follow-up (HR 0.67; 95% CI, 0.51-0.89; P=0.005) and at the final analysis after a median 44 months of follow-up (HR 0.65; 95% CI, 0.53-0.79; P<0.0001).1,2