Xtandi Plus ADT Bolsters Survival in High-risk Patients, Phase 3 Trial Finds

Xtandi Plus ADT Bolsters Survival in High-risk Patients, Phase 3 Trial Finds
Adding Xtandi (enzalutamide) to standard androgen deprivation therapy (ADT) significantly prolonged life by nearly a year for men with high-risk, non-metastatic castration-resistant prostate cancer (CRPC), final data from a Phase 3 clinical trial show. The results, “Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer,” were published in the New England Journal of Medicine and presented at the 2020 American Society of Clinical Oncology (ASCO) annual meeting — held virtually due to the COVID-19 pandemic. “Overall survival is a critical endpoint in evaluating a prostate cancer medicine,” Cora N. Sternberg, MD, the study’s first author and clinical director of the Englander Institute for Precision Medicine at Weill Cornell Medicine, in New York, said in a press release. “These results add to the body of evidence supporting Xtandi’s potential to reduce the risk of death in men with castration-resistant prostate cancer,” she added. Xtandi, an oral hormone therapy developed by Pfizer and Astellas Pharma, is currently approved in the U.S. and in Europe to treat three types of advanced prostate cancer: high-risk non-metastatic CRPC, metastatic CRPC, and metastatic castration-sensitive prostate cancer (mCSPC). Its approval for the treatment of men with high-risk non-metastatic CRPC was based on data from the PROSPER Phase 3 clinical trial (NCT02003924), which evaluated whether adding Xtandi to standard ADT was superior to ADT alone. The trial enrolled 1,401 men with non-metastatic CRPC and rapidly rising prostate-specific antigen (PSA) levels — a marker of disease progression — at more than 300 clinical sites across 32 countries. Participants, who had no symptoms or other evidence of metasta
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