Erleada Cuts Risk of Death by 25% in Localized Castration-resistant Prostate Cancer, Phase 3 Trial Finds

Erleada Cuts Risk of Death by 25% in Localized Castration-resistant Prostate Cancer, Phase 3 Trial Finds
Add-on treatment with Erleada (apalutamide) lowers the risk of death by 25% in men on androgen deprivation therapy (ADT) for non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastases, according to updated results of a Phase 3 trial. The research, “Apalutamide (APA) and Overall Survival (OS) in Patients (pts) With Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): Updated Results From the Phase 3 SPARTAN Study,” was presented at the 2019 European Society for Medical Oncology (ESMO) Congress and published in the journal Annals of Oncology. The double-blind, placebo-controlled, and multicenter SPARTAN trial (NCT0194620) included 1,207 nmCRPC patients with rapidly rising prostate-specific antigen (PSA) levels, as assessed with a PSA Doubling Time of up to 10 months. (PSA Doubling Time refers to the period needed to double the blood level of PSA, and is a common predictor of cancer progression and survival.) Of these people, 806 were given a combination of once-daily Erleada (240 mg) and ADT, and 401 were treated with ADT and a placebo. In a prior analysis, which led to Erleada's approval in both the U.S. and the E.U. for this patient population, researchers showed that Erleada extended the time patients lived without their disease spreading by more than two years — 40.5 months (combo group) versus 16.2 months (placebo group) — representing a 72% reduction in the risk of disease spread or death. At that time, survival results were not mature enough to assess Erleada's superiority. Investigators now report that, after a median follow-up of 41 months, Erleada reduced the risk of death by 25% compared to ADT only. In fact, 72% of patients on Janssen Oncology’s Erleada reached the four
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