Astellas Pharma Inc. (TSE: 4503) and Pfizer Inc. (NYSE: PFE) today reported ground-breaking findings from the Phase 3 EMBARK trial, showing that leuprolide and XTANDI® (enzalutamide) significantly improve overall survival (OS) in men with high-risk biochemical recurrence (BCR) of non-metastatic hormone-sensitive prostate cancer (nmHSPC).
The study’s conclusions, which make XTANDI the first androgen receptor inhibitor-based treatment to show a statistically significant OS improvement, represent a turning point in the management of this particular patient population. The risk of death was significantly lower for patients treated with XTANDI and leuprolide than for those treated with a placebo and leuprolide.
Although there was a positive trend in overall survival in the trial’s arm assessing XTANDI as a monotherapy, the outcome was not statistically significant. Crucially, no new safety issues were found, and the safety profile of XTANDI as seen in the EMBARK study stayed true to its pre-existing safety profile.
XTANDI is the only androgen receptor inhibitor-based regimen to demonstrate a survival benefit in metastatic HSPC and nmHSPC with high-risk BCR, as well as castration-resistant prostate cancer, highlighting its significant patient impact in advanced prostate cancer,
These positive results add to the robust clinical support for the use of XTANDI and broaden clinical confidence, offering men with high-risk BCR evidence that they might live longer when they start XTANDI early.
Johanna Bendell
Considering the difficulties in treating nmHSPC with high-risk BCR, these findings are especially noteworthy. After receiving initial therapy for prostate cancer, a significant portion of men experience a recurrence, and many of these cases develop into metastatic disease. The EMBARK trial’s encouraging results imply that XTANDI early intervention may be essential to prolonging these patients’ lives.
Men with nmHSPC and high-risk BCR were recruited for the multi-national, randomized, double-blind, placebo-controlled EMBARK study. The purpose of the experiment was to assess XTANDI’s safety and effectiveness in this particular patient population.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
