July 22, 2025
The final analysis of the pivotal TITAN Phase III trial, presented in May 2024 after a median follow-up of nearly four years (~44 months), conclusively demonstrated Erleada’s long-term survival advantage in metastatic castration-sensitive prostate cancer (mCSPC). Patients receiving Erleada combined with androgen-deprivation therapy (ADT) experienced a consistent 35% reduction in the risk of death compared to ADT alone. This sustained benefit reaffirms earlier data from the trial’s initial phases and underscores Erleada’s substantial impact on patient survival. The safety profile remained favorable throughout the extended follow-up period, characterized by manageable side effects and minimal significant adverse events. These robust, long-term data provide compelling evidence supporting Erleada’s use as a primary therapeutic option in clinical guidelines for mCSPC, reinforcing its role in standard treatment protocols.
Citation: Globe Newswire, 2024; Johnson & Johnson Press Release, 2024. Available at: https://www.globenewswire.com/news-release/2024/05/03/2875293/0/en/Phase-2-data-for-ERLEADA-apalutamide-plus-androgen-deprivation-therapy-following-radical-prostatectomy-in-patients-with-high-risk-localised-prostate-cancer-shows-100-percent-bioche.html; https://www.jnj.com/media-center/press-releases/erleada-apalutamide-demonstrates-statistically-significant-and-clinically-meaningful-improvement-in-overall-survival-compared-to-enzalutamide-in-patients-with-metastatic-castration-sensitive-prostate-cancer
Implication: This reinforces Erleada’s long-term role as a preferred frontline treatment option for mCSPC.