ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Non-Metastatic Castration-Resistant Prostate Cancer

RARITAN, NJ, May 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA® (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.[i] Results will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program (Abstract #5516) beginning May 29th. ERLEADA® in combination with ADT prolonged median overall survival by 14 months and decreased the risk of death by 22 percent.1 Median OS was significantly longer, with 73.9 months for patients receiving treatment with ERLEADA® in combination with ADT compared to 59.9 months with patients receiving placebo in combination with ADT [HR=0.78; p=0.0161 (to reach statistical significance, a p-value of p<0.046 needed to be observed)].1 After the study met its primary endpoint of metastasis-free survival (MFS), the SPARTAN study was unblinded and patients on placebo were allowed to crossover to ERLEADA®. The OS results were achieved despite a crossover of 76 randomized placebo patients (19 percent) to ERLEADA® treatment.1 After adjusting for the crossover of patients in the placebo arm, the treatment effect of ERLEADA® plus ADT exceeded median OS compared to placebo plus ADT w...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news