Phase 3 Trial Demonstrates Positive Results for Enzalutamide in Prostate Cancer

Positive results were based on the PROSPER trial, which evaluated the overall survival of enzalutamide plus androgen deprivation therapy versus standard of care.

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.