Pfizer and Astellas Pharma Inc. today announced important long-term overall survival (OS) results for XTANDI™ (enzalutamide) in men with metastatic hormone-sensitive prostate cancer (mHSPC). The results are based on the Phase 3 ARCHES trial and further solidify XTANDI plus androgen deprivation therapy (ADT) as an essential treatment option.
The ARCHES trial proved that XTANDI with ADT decreased the risk of death by a remarkable 30% versus placebo plus ADT. Indeed, patients receiving the XTANDI regimen were 66% likely to survive at five years, which is a big jump from the 53% likelihood of survival in the placebo plus ADT cohort. This places XTANDI as the first and only androgen receptor inhibitor to prove an overall five-year survival benefit in this patient group.
The favorable outcomes were sustained in different patient subgroups with high-volume disease, previously untreated docetaxel, and synchronous disease. For patients with high-volume disease alone, there was a 36-month increase in median overall survival. These strong long-term results affirm XTANDI in combination with ADT as a treatment standard for mHSPC.
Further validating these results, investigator-sponsored ENZAMET study eight-year data also showed decreased mortality in men with mHSPC receiving XTANDI. In the ENZAMET trial, the median OS was 8.0 years for XTANDI versus 5.8 years for those receiving nonsteroidal antiandrogen (NSAA). Overall survival at 96 months (eight years) was 50% with XTANDI compared to 40% with NSAA. Progression-free survival was also in favor of the XTANDI treatment group.
The comprehensive results of the ARCHES trial will be featured in an ASCO Annual Meeting presentation in Chicago on Tuesday, June 3, 2025.
These long-term data reinforce the long-lasting effectiveness of XTANDI for the treatment of metastatic hormone-sensitive prostate cancer, bringing fresh hope and better treatment for patients struggling with this aggressive disease.
Last Modified:
