Phase 3 Trial Demonstrates Positive Results for Enzalutamide in Prostate Cancer

Positive results have been announced from the phase 3 PROSPER trial, which evaluated the overall survival (OS) from enzalutamide (Xtandi, Astellas Pharma) plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC).¹

The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with enzalutamide plus ADT. In a preliminary analysis, adverse events were generally consistent with those previously reported from PROSPER.¹

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Published in The New England Journal of Medicine, PROSPER was a randomized, double-blind, placebo-controlled, multi-national trial, which enrolled approximately 1400 patients with nmCRPC. Participants had a previous diagnosis of prostate cancer that had progressed, measured by a rising prostate-specific antigen (PSA) level despite ADT, but had no symptoms and no prior or present evidence of metastatic disease. The trial evaluated enzalutamide at a dose of 160 mg taken orally once daily.²

The primary end point was metastasis-free survival, defined as the time from randomization to radiographic progression or as the time to death without radiographic progression. Among men with nmCRPC with a rapidly rising PSA level, enzalutamide treatment led to a clinically meaningful and significant 71% lower risk of metastasis or death than placebo.²

Detailed efficacy and safety results from the final OS analysis based on the PROSPER trial will be shared at a later date.¹

References

• XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC [news release]. Tokyo, Japan and New York, NY. PR Newswire website. Published February 11, 2020. https://www.prnewswire.com/news-releases/xtandi-enzalutamide-demonstrates-significant-improvement-in-overall-survival-in-phase-3-prosper-trial-of-patients-with-nmcrpc-301002463.html. Accessed February 11, 2020.
• Hussain, M, Fizazi, K, Saad, F, et al. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. The New England Journal of Medicine 2018; 378:2465-2474. DOI: 10.1056/NEJMoa1800536.