Largest real-world study demonstrates significant survival advantage.
In a landmark study, Johnson & Johnson has announced that ERLEADA (apalutamide) significantly reduces the risk of death by 23% at 24 months compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC).
The findings were presented at the 6th European Congress of Oncology Pharmacy (ECOP) in Lisbon, Portugal.
The study, which is the largest real-world, head-to-head analysis of these two androgen receptor pathway inhibitors (ARPIs) in mCSPC, involved nearly 4,000 patients. It followed US Food and Drug Administration (FDA) real-world evidence guidance and employed robust methodology and diverse data sources to ensure the validity of its findings.
Patients who initiated ERLEADA between December 16, 2018, and December 31, 2023, showed a statistically significant 23% reduction in the risk of death at 24 months compared to those who started on enzalutamide.
“This real-world evidence showed a statistically significant and clinically meaningful improvement in survival with apalutamide over enzalutamide in patients with mCSPC at 24 months,” said Dr Neal Shore, Steering Committee Chair and Medical Director at the Carolina Urologic Research Center.
“This real-world study is provocative as the comprehensive data and rigorous methodology used in this study offers real-world insights on overall survival which can provide prescribers with information to consider when choosing an ARPI,” he added.
Dr Luca Dezzani, US Vice President of Medical Affairs, Solid Tumors at Johnson & Johnson, added: “ERLEADA is the only ARPI to demonstrate a survival benefit as early as 22 months, as seen in the TITAN study. With a decade-plus legacy in prostate cancer, we have pushed the field further with this additional evidence showing an overall survival benefit with ERLEADA, which is a patient-centric option taken as just one pill, once daily.”
The study did note some limitations, including potential miscoding or missing information in the data sources, but deemed the data sources fit for purpose to correctly identify the patient population and assess survival.
