Apalutamide Significantly Improved Overall Survival in Patients with Non-Metastatic Castration-Resistant Prostate Cancer
Apalutamide in combination with ADT prolonged median OS by 14 months and decreased the risk of death by 22%. Further, median OS was significantly longer, with 73.9 months for patients receiving treatment with apalutamide in combination with ADT compared with 59.9 months for patients receiving placebo in combination with ADT.
Results from the final analysis of the pivotal phase 3 SPARTAN study demonstrated that apalutamide (Erleada, Janssen Pharmaceutical) in combination with androgen deprivation therapy (ADT) leads to a significant improvement in overall survival (OS) compared with ADT alone in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at a high risk of developing metastases.
The SPARTAN study evaluated apalutamide in combination with ADT in men with nmCRPC with a rapidly rising prostate specific antigen. The study enrolled 1207 patients who were randomized 2:1 to receive either apalutamide orally at a dose of 240 mg once daily in combination with ADT or placebo once daily in combination with ADT.
Apalutamide in combination with ADT prolonged median OS by 14 months and decreased the risk of death by 22%. Further, median OS was significantly longer, with 73.9 months for patients receiving treatment with apalutamide in combination with ADT compared with 59.9 months for patients receiving placebo in combination with ADT.
After the study met its primary endpoint of metastasis-free survival, the SPARTAN study was unblinded and patients on placebo were allowed to crossover to apalutamide. The OS results were achieved despite a crossover of 76 randomized placebo patients to apalutamide treatment.
The treatment effect of apalutamide plus ADT exceeded median OS compared with placebo plus ADT with a difference of 21 months between the 2 arms. Further, treatment with apalutamide in combination with ADT significantly delayed patients’ time to cytotoxic chemotherapy compared with placebo in combination with ADT.
REFERENCE
ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Non-Metastatic Castration-Resistant Prostate Cancer. PR Newswire. https://www.prnewswire.com/news-releases/erleada-apalutamide-significantly-improved-overall-survival-in-patients-with-non-metastatic-castration-resistant-prostate-cancer-301058911.html?tc=eml_. Published May 13, 2020. Accessed June 10, 2020.
